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  • 1. Abu-Elyazeed, R R
    et al.
    Heineman, T
    Dubin, G
    Fourneau, M
    Leroux-Roels, I
    Leroux-Roels, G
    Richardus, J H
    Ostergaard, L
    Diez-Domingo, J
    Poder, A
    Van Damme, P
    Romanowski, B
    Blatter, M
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Berglund, J
    Josefsson, A
    Cunningham, A L
    Flodmark, C E
    Tragiannidis, A
    Dobson, S
    Olafsson, J
    Puig-Barbera, J
    Mendez, M
    Barton, S
    Bernstein, D
    Mares, J
    Ratner, P
    Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial2013In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 31, no 51, p. 6136-6143Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed.

    METHODS: Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus.

    RESULTS: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants.

    CONCLUSION: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.

  • 2. Bucht, Göran
    et al.
    Sjölander, Katarina Brus
    Eriksson, Solveig
    Lindgren, Lena
    Lundkvist, Åke
    Elgh, Fredrik
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Virology.
    Modifying the cellular transport of DNA-based vaccines alters the immune response to hantavirus nucleocapsid protein2001In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 19, no 28-29, p. 3820-3829Article in journal (Refereed)
    Abstract [en]

    Puumala virus is a member of the hantavirus genus (family Bunyaviridae) and is one of the causative agents of hemorrhagic fever with renal syndrome (HFRS) in Europe. A genetic vaccination approach was conducted to investigate if the immune response could be modulated using different cellular secretion and/or localisation signals, and the immune responses were analysed in BALB/c mice and in a bank vole infectious model. Rodents vaccinated with DNA constructs encoding the antigen fused to an amino-terminal secretion signal raised significantly higher antibody levels when compared to using constructs lacking secretion signals. Furthermore, the ratios of the IgG subclasses (IgG2a/IgG1) were raised by the use of cellular localisation signals, indicating a more pronounced Th1-type of immune response. The majority of the mice, or bank voles, immunised with DNA encoding a secreted form of the antigen showed a positive lymphoproliferative response and were protected against challenge with Puumala virus (strain Kazan-wt).

  • 3.
    Carlsson, R. M.
    et al.
    Göteborg, Sweden; Public Health Agency of Sweden, Sweden.
    Gustafsson, L.
    Public Health Agency of Sweden, Sweden.
    Hallander, H. O.
    Public Health Agency of Sweden, Sweden.
    Ljungman, M.
    Public Health Agency of Sweden, Sweden.
    Olin, P.
    Public Health Agency of Sweden, Sweden.
    Gothefors, Leif
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics. Public Health Agency of Sweden, Sweden.
    Nilsson, L.
    Public Health Agency of Sweden, Sweden; Linköping, Sweden.
    Netterlid, E.
    Public Health Agency of Sweden, Sweden; Malmö, Sweden.
    Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years2015In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 33, no 31, p. 3717-3725Article in journal (Refereed)
    Abstract [en]

    Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed or separate injections of a reduced antigen vaccine (Tdap5, Sanofi Pasteur MSD) and an inactivated polio vaccine, and 230 adolescents received the same or another booster vaccine (Tdap1, SSI, Denmark). Pre-vaccination antibody concentrations against pertussis antigens were significantly higher at 15 than 5 years of age, probably due to natural boosting between the studies. Tdap5 induced comparable anti-PT concentrations at both ages, but antibody responses were significantly higher to filamentous haemagglutinin, pertactin and fimbriae 2/3 in adolescents. As expected, a higher amount of PT (Tdap1, 20 mu g) induced a stronger anti-PT response than a lower amount (Tdap5, 2.5 mu g). The frequency of adverse events was low and there were no serious adverse reactions. All local reactions had an early onset and a short duration. A large swelling or redness of more than half of the upper arm circumference was reported in 8/475 5-year-olds and in 6/230 15-year-olds. Children vaccinated with Tdap5 reported more moderate pain in adolescence than at preschool age, whereas itching was only reported in preschool children. Sweden introduced DTaP vaccines in 1996 after a 17-year hiatus with no general pertussis vaccination and pertussis was still endemic at the time of the studies. The frequency of adverse events was nevertheless low in both preschool children and adolescents and antibody responses were adequate. These studies document immunogenicity and reactogenicity in a trial cohort consecutively vaccinated with acellular pertussis vaccines from infancy to adolescence. (C) 2015 Elsevier Ltd. All rights reserved.

  • 4.
    Conlan, J Wayne
    et al.
    NRC, Kanada.
    Shen, Hua
    Golovliov, Igor
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Clinical Bacteriology.
    Zingmark, Carl
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Clinical Bacteriology.
    Oyston, Petra CF
    Chen, Wangxue
    House, Robert V
    Sjöstedt, Anders
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Clinical Bacteriology.
    Differential ability of novel attenuated targeted deletion mutants of Francisella tularensis subspecies tularensis strain SCHU S4 to protect mice against aerosol challenge with virulent bacteria: effects of host background and route of immunization2010In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 28, no 7, p. 1824-1831Article in journal (Refereed)
    Abstract [en]

    Francisella tularensis subspecies tularensis is a highly virulent facultative intracellular pathogen of humans and a potential biological weapon. A live vaccine strain, F. tularensis LVS, was developed more than 50 years ago by pragmatic attenuation of a strain of the less virulent holarctica subspecies. LVS was demonstrated to be highly effective in human volunteers who were exposed to intradermal challenge with fully virulent subsp. tularensis, but was less effective against aerosol exposure. LVS faces regulatory hurdles that to date have prevented its licensure for general use. Therefore, a better defined and more effective vaccine is being sought. To this end we have created gene deletion mutants in the virulent subsp. tularensis strain and tested them for their ability to elicit a protective immune response against systemic or aerosol challenge with the highly virulent wild-type subsp. tularensis strain, SCHU S4. Both oral and intradermal (ID) primary vaccination routes were assessed in BALB/c and C3H/HeN mice as was oral boosting. One SCHU S4 mutant missing the heat shock gene, clpB, was significantly more attenuated than LVS whereas a double deletion mutant missing genes FTT0918 and capB was as attenuated as LVS. In general mice immunized with SCHU S4DeltaclpB were significantly better protected against aerosol challenge than mice immunized with LVS. A single ID immunization of BALB/c mice with SCHU S4DeltaclpB was at least as effective as any other regimen examined. Mice immunized with SCHU S4Delta0918DeltacapB were generally protected to a similar degree as mice immunized with LVS. A preliminary examination of immune responses to vaccination with LVS, SCHU S4DeltaclpB, or SCHU S4Delta0918DeltacapB provided no obvious correlate to their relative efficacies.

  • 5. Gessner, Bradford D
    et al.
    Wilder-Smith, Annelies
    Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Institute of Public Health, University of Heidelberg, Germany.
    Estimating the public health importance of the CYD-tetravalent dengue vaccine: vaccine preventable disease incidence and numbers needed to vaccinate2016In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 34, no 20, p. 2397-2401Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: To evaluate the potential public health impact of the live attenuated tetravalent Sanofi Pasteur dengue vaccine (CYD-TDV) we analyzed data from the reported clinical trials to calculate vaccine preventable disease incidence (VPDI) and number needed to vaccinate (NNV) based on the licensure indication for persons age 9 years and above.

    METHODS: VPDI is defined as incidence in an unvaccinated population X vaccine efficacy (VE), and thus incorporates both VE and the underlying burden of disease. NNV was calculated as 100,000 divided by VPDI divided by 2-year length of study. We compared these values to data for three newer vaccines that are currently integrated into some national immunization programs in Asia and Latin America, namely pneumococcal conjugate, Haemophilus influenzae type b, and rotavirus vaccines.

    RESULTS: In the Asian-Pacific trial, in the first 25 months after the first dose of the dengue vaccine, CYD-TDV prevented annually 2639 cases of virologically confirmed dengue for every 100,000 persons vaccinated, for an NNV of 18. In the Latin American trial, given the overall lower annual dengue incidence compared to Asia, VPDI was 1707, and NNV 28. For the Asian-Pacific and Latin American studies, the VPDIs for hospitalized virologically confirmed disease at the trials' end were 638 and 239 per 100,000 population per year, respectively, with NNVs of 75 and 201. VPDI for confirmed dengue hospitalization was higher than that for Hib vaccine against Hib meningitis or all cause severe pneumonia while lower than that for rotavirus vaccine against severe rotavirus gastroenteritis.

    CONCLUSIONS: Our analysis found that the CYD-TDV dengue vaccine had favorable VPDI and NNV, also when compared to existing vaccines used in Latin America and Asia. VPDI and NNV varied by serotype distribution, extent of prior dengue exposure (baseline seroprevalence) and country. These findings will help policy-makers decide where and how to introduce this vaccine post-licensure.

  • 6. Harrison, Lee H
    et al.
    Pelton, Stephen I
    Wilder-Smith, Annelies
    Institute of Public Health, University of Heidelberg, Germany.
    Holst, Johan
    Safadi, Marco A P
    Vazquez, Julio A
    Taha, Muhamed-Kheir
    LaForce, F Marc
    von Gottberg, Anne
    Borrow, Ray
    Plotkin, Stanley A
    The global Meningococcal initiative: recommendations for reducing the global burden of meningococcal disease2011In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 29, no 18, p. 3363-3371Article in journal (Refereed)
    Abstract [en]

    The Global Meningococcal Initiative (GMI) is composed of an international group of scientists, clinicians and public health officials with expertise in meningococcal immunology, epidemiology and prevention. The primary goal of the GMI is the promotion of the global prevention of invasive meningococcal disease through education and research. The GMI members reviewed global meningococcal disease epidemiology, immunization strategies, and research needs. Over the past decade, substantial advances in meningococcal vaccine development have occurred and much has been learned about prevention from countries that have incorporated meningococcal vaccines into their immunization programs. The burden of meningococcal disease is unknown for many parts of the world because of inadequate surveillance, which severely hampers evidence-based immunization policy. As the field of meningococcal vaccine development advances, global surveillance for meningococcal disease needs to be strengthened in many regions of the world. For countries with meningococcal vaccination policies, research on vaccine effectiveness and impact, including indirect effects, is crucial for informing policy decisions. Each country needs to tailor meningococcal vaccination policy according to individual country needs and knowledge of disease burden. Innovative approaches are needed to introduce and sustain meningococcal vaccination programs in resource-poor settings with a high incidence of meningococcal disease.

  • 7.
    Jacquet, J M
    et al.
    GlaxoSmithKline Biologicals, Rixensart, Belgium.
    Bégué, P
    Hôpital d’enfants Armand Trousseau, Paris, France.
    Grimprel, E
    Hôpital d’enfants Armand Trousseau, Paris, France.
    Reinert, P
    Hôpital Intercommunal de Créteil, France.
    Sandbu, S
    Norwegian Institute of Public Health, Oslo, Norway.
    Silfverdal, S A
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Faldella, G
    Universita di Bologna, Italy.
    Nolan, T
    Murdoch Children's Research Institute, and the School of Population Health at the University of Melbourne, Parkville, Australia.
    Lambert, S
    Murdoch Children's Research Institute, and the School of Population Health at the University of Melbourne, Parkville, Australia.
    Richmond, P
    University of Western Australia, Perth, Australia.
    Marshall, H
    University of Adelaide, North Adelaide, Australia.
    Roberton, D
    University of Adelaide, North Adelaide, Australia.
    Schuerman, L
    GlaxoSmithKline Biologicals, Rixensart, Belgium.
    Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age: a review2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 13, p. 2440-2448Article in journal (Refereed)
    Abstract [en]

    A combined DTPa-IPV booster vaccine was administered as a 4th or 5th dose after DTPa or DTPw priming. Over 99% vaccines developed antibody levels considered to be protective to diphtheria, tetanus and poliovirus, and >95% mounted a response to acellular pertussis antigens. Rectal temperature >39.5 degrees C was observed in at most 3.2% of vaccinees. Swelling >50 mm occurred in 24% of DTPa-primed compared to 5.5% of DTPw-primed children. Large swelling involving the entire upper arm (extending to involve the elbow joint) was reported for up to 1.2% of DTPa-primed subjects, which is consistent with literature reports for other DTPa vaccines.

  • 8.
    Johansson, Patrik
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Virology.
    Lindgren, Therese
    Lundström, Marlene
    Holmström, Anna
    Swedish Defence Research Agency, Division of CBRN Defence and Security, SE-901 82 Umeå, Sweden.
    Elgh, Fredrik
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Virology.
    Bucht, Göran
    PCR-generated linear DNA fragments utilized as a hantavirus DNA vaccine2002In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 20, no 27-28, p. 3379-3388Article in journal (Refereed)
    Abstract [en]

    The field of DNA vaccines has grown rapidly, and since most such vaccines involve the inoculation of large circular DNA molecules previously propagated in bacteria, several inconveniences (e.g. the presence of antibiotic resistance genes, impurities from bacterial cultures or inefficient uptake of the large and bulky plasmid DNA molecules to the nucleus) are debated. In this study, we have explored the possibility of using smaller and more flexible PCR-generated linear DNA fragments instead. Phosphorothioate (PTO)-modified primers were used successfully to protect the PCR-generated DNA fragments from exonuclease degradation, and by using a nuclear localization signal-peptide to target the linear DNA to the nucleus the immune response against the encoded antigen was further improved. This approach was tested in cell culture using a sensitive reporter system and in vivo with DNA encoding the amino-terminus of the Puumala hantavirus nucleocapsid protein. Our results indicate that linear DNA fragments have a great potential as a genetic vaccine and phosphorothioate modification in combination with a nuclear localization signal peptide increase the stability and targets the linear DNA molecules to the nucleus resulting in an improved biological response examined both in vitro and in vivo.

  • 9. Jones, James F
    et al.
    Kohl, Katrin S
    Ahmadipour, Nooshin
    Bleijenberg, Gijs
    Buchwald, Dedra
    Evengård, Birgitta
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Jason, Leonard A
    Klimas, Nancy G
    Lloyd, Andrew
    McCleary, Kimberly
    Oleske, James M
    White, Peter D
    Fatigue: case definition and guidelines for collection, analysis, and presentation of immunization safety data.2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 31, p. 5685-96Article in journal (Refereed)
  • 10.
    Lindkvist, Marie
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Lahti, Katarina
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Lilliehöök, Bo
    Holmström, Anna
    Swedish Defence Research Agency, Division of CBRN Defence and Security, SE-901 82 Umeå, Sweden.
    Ahlm, Clas
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Bucht, Göran
    Cross-reactive immune responses in mice after genetic vaccination with cDNA encoding hantavirus nucleocapsid proteins.2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 9, p. 1690-1699Article in journal (Refereed)
    Abstract [en]

    Hantaviruses cause hemorrhagic fever with renal syndrome (HFRS) in about 150,000 individuals in Eurasia, and several hundred cases of hantavirus pulmonary syndrome (HPS) on the American continent annually. There is consequently a need for rapid diagnostics and effective prevention of hantaviral infections. In this study we have performed DNA-vaccination of mice with full-length genes encoding the immunogenic nucleocapsid protein (NP) of Puumala (PUUV), Seoul (SEOV) and Sin Nombre virus (SNV). The antibody reactivity towards the NPs, and deleted or truncated variants thereof, were studied to localise and investigate the major polyclonal B-cell epitopes. Our findings clearly show that the antibody reactivity in each immunised mouse is unique, not only in a quantitative respect (titers) but also in cross-reactivity and most likely also in the epitope specificity. Our experimental data in combination with B-cell prediction software indicate that strong homologous virus species specific and cross-reactive epitopes are located around amino acid residue 40 in the nucleocapsid proteins.

  • 11. Mallet, Eric
    et al.
    Belohradsky, Bernd H
    Lagos, Rosanna
    Gothefors, Leif
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Camier, Patrice
    Carrière, Jean-Pierre
    Kanra, Güler
    Hoffenbach, Agnès
    Langue, Jacques
    Undreiner, François
    Roussel, François
    Reinert, Philippe
    Flodmark, Carl-Erik
    Stojanov, Silvia
    Liese, Johannes
    Levine, Myron M
    Muñoz, Alma
    Schödel, Florian
    Hessel, Luc
    A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety.2004In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 22, no 11-12, p. 1343-57Article in journal (Refereed)
    Abstract [en]

    To reduce the number of injections needed to comply with paediatric vaccination requirements, a liquid, hexavalent vaccine (DTaP-IPV-PRP-T-HBs; Hexavac; Aventis Pasteur MSD) has been developed for primary and booster vaccination of infants and toddlers. In extensive clinical studies, Hexavac has been shown to be highly immunogenic. Seroconversion or seroprotective titres of antibodies against all antigens were achieved in the majority of infants following a primary series of three doses administered at 1-2-month intervals from 2 months of age. Hexavac also induced immunologic memory, as evidenced by the anamnestic response to booster vaccination at 12-18 months of age. These responses were comparable with those seen following concomitant administration of Pentavac (DTaP-IPV//PRP-T) and monovalent hepatitis B vaccine (H-B-Vax II), and were also within the ranges observed for other relevant licensed vaccines. Clinical studies comparing the immunogenicity of Hexavac administered at either 2, 3 and 4 months or 2, 4 and 6 months demonstrated that it can be used by either vaccination schedule. A further study also supported the use of primary doses of Hexavac at 3 and 5 months with a booster at 12 months of age. Hexavac demonstrated a good reactogenicity and tolerability profile. The most frequently reported adverse events after both primary and booster doses were local reactions of redness and swelling/induration and a systemic response of mild fever, irrespective of the vaccine used for priming. Hexavac provided immunity against six important childhood diseases with a single injection at each visit.

  • 12. Munster, Vincent J
    et al.
    Veen, Jan
    Olsen, Björn
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Vogel, Rob
    Osterhaus, Albert D M E
    Fouchier, Ron A M
    Towards improved influenza A virus surveillance in migrating birds.2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 44-46, p. 6729-33Article in journal (Refereed)
    Abstract [en]

    The last decade has seen a marked increase in highly pathogenic avian influenza (HPAI) outbreaks around the world. This increase and the zoonotic potential of some of the HPAI viruses are of great concern to animal and public health as well as biodiversity. It is now well recognized that global influenza virus surveillance in wild birds can play a key role in the early recognition of and preparation for these threats. Here we summarize the most important results from our wild bird surveillance studies in Northern Europe over the last 8 years and conclude that surveillance studies in wild birds are indeed useful to generate prototypic vaccine candidates and to design and evaluate diagnostic tests, prior to the occurrence of outbreaks in animals and humans. Through this 8-year experience we also identified gaps in our knowledge on influenza A viruses and their natural hosts which may help to assist in the design of improved surveillance studies. This is particularly relevant if wild bird surveillance studies are used as an "early warning system" for the arrival of the H5N1 HPAI virus in a country or region and to assess the risk posed by these viruses in general.

  • 13. Mvundura, Mercy
    et al.
    Kien, Vu Duy
    Nga, Nguyen Tuyet
    Robertson, Joanie
    Cuong, Nguyen Van
    Tung, Ho Thanh
    Hong, Duong Thi
    Levin, Carol
    How much does it cost to get a dose of vaccine to the service delivery location? Empirical evidence from Vietnam's Expanded Program on Immunization.2014In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 32, no 7, p. 834-8Article in journal (Refereed)
    Abstract [en]

    Few studies document the costs of operating vaccine supply chains, but decision-makers need this information to inform cost projections for investments to accommodate new vaccine introduction. This paper presents empirical estimates of vaccine supply chain costs for Vietnam's Expanded Program on Immunization (EPI) for routine vaccines at each level of the supply chain, before and after the introduction of the pentavalent vaccine. We used micro-costing methods to collect resource-use data associated with storage and transportation of vaccines and immunization supplies at the national store, the four regional stores, and a sample of provinces, districts, and commune health centers. We collected stock ledger data on the total number of doses of vaccines handled by each facility during the assessment year. Total supply chain costs were estimated at approximately US$65,000 at the national store and an average of US$39,000 per region, US$5800 per province, US$2200 per district, and US$300 per commune health center. Across all levels, cold chain equipment capital costs and labor were the largest drivers of costs. The cost per dose delivered was estimated at US$0.19 before the introduction of pentavalent and US$0.24 cents after introduction. At commune health centers, supply chain costs were 104% of the value of vaccines before introduction of pentavalent vaccine and 24% after introduction, mainly due to the higher price per dose of the pentavalent vaccine. The aggregated costs at the last tier of the health system can be substantial because of the large number of facilities. Even in countries with high-functioning systems, empirical evidence on current costs from all levels of the system can help estimate resource requirements for expanding and strengthening resources to meet future immunization program needs. Other low- and middle-income countries can benefit from similar studies, in view of new vaccine introductions that will put strains on existing systems.

  • 14. Nzenze, S. A.
    et al.
    Shiri, T.
    Nunes, M. C.
    Klugman, K. P.
    Kahn, Kathleen
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa ; INDEPTH Network, Accra, Ghana.
    Twine, R.
    de Gouveia, L.
    von Gottberg, A.
    Madhi, S. A.
    Temporal association of infant immunisation with pneumococcal conjugate vaccine on the ecology of Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus nasopharyngeal colonisation in a rural South African community2014In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 32, no 42, p. 5520-5530Article in journal (Refereed)
    Abstract [en]

    Background: Immunisation of children with pneumococcal conjugate vaccines (PCV) may affect the bacterial-ecology of the nasopharynx, including colonisation by Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus. The aim of this study was to evaluate the effect of infant PCVimmunisation on the nasopharyngeal ecology of these potentially pathogenic bacteria in a rural African setting. Methods: Two cross sectional surveys were undertaken from May to October in 2009 (Period-1) which coincided with the introduction of 7-valent PCV (PCV7) and in May-October 2011 (Period-2). Consenting household members, where there was a child <2 years of age in residence, had nasopharyngeal swabs undertaken for culture. Results: From Period-1 to Period-2 in children 0-2 years and 3-12 years, prevalence of overall S. pneumoniae colonisation decreased from 74.9% to 67.0% (p < 0.001) and H. influenzae declined among children 3-12 years (55.1-45.3%, p < 0.001) but not among those <2 years. The prevalence of S. aureus remained unchanged in all children. Competitive associations were found between S. pneumoniae and S. aureus and between H. influenzae and S. aureus among children. In individuals >12 years, the prevalence of colonisation decreased from 11.2% to 6.8%, 16.7% to 8.8% and 31.2% to 23.7% for S. pneumoniae, H. influenzae and S. aureus, respectively; p < 0.001 for all comparions. Synergistic relationships for S. aureus with H. influenzae and S. pneumoniae were observed in both periods among this group.

  • 15. Prymula, Roman
    et al.
    Szenborn, Leszek
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Wysocki, Jacek
    Albrecht, Piotr
    Traskine, Magali
    Gardev, Asparuh
    Song, Yue
    Borys, Dorota
    Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: results from a randomized phase II study in infants2017In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 35, no 35B, p. 4603-4611Article in journal (Refereed)
    Abstract [en]

    Introduction: Vaccination with formulations containing pneumococcal protein antigens such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) may extend serotype-related protection of pneumococcal conjugate vaccines (PCVs) against Streptococcus pneumoniae.

    Methods: This phase II, multi-center, observer-blind trial conducted in Europe (NCT01204658) assessed 2 investigational vaccines containing 10 serotype-specific polysaccharide conjugates of PHiD-CV and either 10 or 30 mu g of dPly and PhtD each. Infants randomized 1:1:1:1 received 4 doses of PHiD-CV/dPly/PhtD-10, PHiD-CV/c1Ply/PhtD-30, PHiD-CV, or 13-valent PCV (PCV13), co-administered with DTPa-HBV-IPV/Flib, at ages 2, 3, 4 and 12-15 months. Occurrences of fever >40.0 degrees C following primary vaccination with PHiD-CV/dPly/PhtD vaccines compared to PHiD-CV (non-inferiority objective), dose superiority, safety and immunogenicity were assessed.

    Results: 575 children received primary vaccination, and 564 booster vaccination. The non-inferiority objective was met; no fever >40.0 degrees C causally related to vaccination was reported during primary vaccination. Incidence of adverse events appeared similar between the 3 PHiD-CV groups. Serious adverse events were reported in 13, 9, 21 (1 related to vaccination), and 17 children in the PHiD-CV/c1Ply/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV, and PCV13 groups, respectively. PHiD-CV/dPly/PhtD-30 was superior to PHiD-CV/c1Ply/PhtD-10 in terms of post-dose 3 anti-Ply and Anti-PhtD antibody levels. Anti-Ply and anti-PhtD antibody levels were higher in both PHiD-CV/dPly/PhtD groups than in controls and increased from post-primary to post-booster timepoint. Post-primary and booster vaccination, for each PHiD-CV serotype, >= 98.5% of participants in PHiD-CV/dPly/PhtD groups had antibody concentrations >= 0.2 mu g/mL, except for 6B (>= 72.3%) and 23 F (>= 82.7%) post-primary vaccination. Similar results were observed in the PHiD-CV group. Immune responses to protein D and DTPa-HBV-IPV/Hib were within similar ranges for the 3 PHiD-CV groups.

    Conclusion: Both PHiD-CV/dPly/PhtD formulations co-administered with DTPa-HBV-IPV/Hib in infants were well-tolerated and immunogenic for dPly and PhtD antigens, while immune responses to serotype-specific, protein D and co-administered antigens did not appear altered in comparison to PHiD-CV group. 

  • 16. Seele, Jana
    et al.
    Hillermann, Lena-Maria
    Beineke, Andreas
    Seitz, Maren
    von Pawel-Rammingen, Ulrich
    Umeå University, Faculty of Medicine, Department of Molecular Biology (Faculty of Medicine). Umeå University, Faculty of Medicine, Umeå Centre for Microbial Research (UCMR).
    Valentin-Weigand, Peter
    Baums, Christoph G.
    The immunoglobulin M-degrading enzyme of Streptococcus suis, Ide(Ssuis), is a highly protective antigen against serotype 22015In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 33, no 19, p. 2207-2212Article in journal (Refereed)
    Abstract [en]

    Streptococcus suis (S. suis) is a major porcine pathogen causing meningitis, arthritis and several other pathologies. Recently, we identified a highly specific immunoglobulin M degrading enzyme of S. suis, designated IdeSsuis, which is expressed by various serotypes. The objective of this work was to access the immunogenicity and protective efficacy of a recombinant vaccine including IdeSsuis. Vaccination with rIdeSsuis elicited antibodies efficiently neutralizing the IgM protease activity. Importantly, 18 piglets vaccinated with rIdeSsuis alone or in combination with bacterin priming were completely protected against mortality and severe morbidity after S. suis serotype 2 challenge. In contrast, 12 of the 17 piglets either treated with the placebo or primed with the bacterin only, succumbed to S. suis disease. Immunity against Idessuis was associated with increased killing of S. suis wt in porcine blood ex vivo leading to a tenfold difference in the bacterial survival factor in blood of placebo-treated and rIdeSsuis-vaccinated piglets. In conclusion, the results of this study indicate that rIdeSsuis is a highly protective antigen in pigs.

  • 17.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Clinical Sciences, Paediatrics.
    Berg, Stefan
    Hemlin, Claes
    Jokinen, Iiro
    The cost-burden of paediatric pneumococcal disease in Sweden and the potential cost-effectiveness of prevention using 7-valent pneumococcal vaccine.2009In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 27, no 10, p. 1601-1608Article in journal (Refereed)
    Abstract [en]

    AIMS: A cost-effectiveness model was used to estimate the change in disease burden that might be expected if PCV7 was included as part of the routine 3-dose vaccination schedule in Sweden. METHODS: An economic model was populated with data from the main clinical PCV7 efficacy trials, demographic data from government sources, surveillance and epidemiologic data from the US and Nordic region, and average treatment costs, considering the impact of disease on the whole national population. RESULTS: The model estimated that PCV7 would prevent 18,856 cases of AOM, 684 of pneumonia, 86 of pneumococcal bacteraemia and 21 cases of pneumococcal meningitis in children <10 years, further 221 cases of IPD would be avoided in older children and adults and 397 cases of pneumonia in adults aged 18-39 years. Annually, 4 childhood (<10 years) deaths and 39 deaths in older children and adults would be prevented, resulting in an annual saving of 632 life years. The reduction of cost for the society was estimated to 27.9 (-205, +160) million SEK. The sensitivity analysis showed that it was most sensitive to the efficacy of the vaccine against AOM, the cost of managing infections and the incidence of all disease. CONCLUSION: This model demonstrates that implementing a universal vaccine programme in Sweden with PCV7 would be cost-effective with an estimated net reduction of costs for the society.

  • 18.
    Silfverdal, Sven Arne
    et al.
    Department of Paediatrics, Örebro University Hospital, Örebro, Sweden.
    Ehlin, A
    Clinical Epidemiology Unit, Department of Medicine, Karolinska Hospital, Karolinska Institutet, Sweden.
    Montgomery, S M
    Clinical Research Centre, Örebro University Hospital, Örebro, Sweden.
    Protection against clinical pertussis induced by whole-cell pertussis vaccination is related to primo-immunisation intervals2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 43, p. 7510-7515Article in journal (Refereed)
    Abstract [en]

    AIMS: Information on subjects who had at least three immunisations against pertussis was provided by longitudinal data from the 1970 British Cohort Study (BCS70) and used to assess whether three whole-cell pertussis (wP) immunisations given within less than 5 months confer less effective protection in childhood compared with a schedule with a longer interval. METHODS: Age at pertussis infection was the dependent variable in a Cox regression analysis, to investigate associations with duration between first and third pertussis immunisation; with third immunisation modelled as a time-dependent covariate. Adjustment was for number of pertussis immunisations (three or four), sex, social class and other potential confounding factors. RESULTS: A total of 8545 children were included in the analysis and 556 had a history of whooping cough. A duration of over 4 months between first and third pertussis immunisations is statistically significantly associated with a reduced risk of pertussis infection by age 10 years, compared with three immunisations given over a shorter period, producing a statistically significant adjusted hazard ratio of 0.74 (0.62-0.92). A fourth immunisation against pertussis further enhanced the protective effect with a hazard ratio of 0.59 (0.44-0.82). CONCLUSION: These results were based on a historical UK cohort using wP vaccine, and indicate that a vaccination schedule with an interval between the immunisations greater than 4 months, and also including a fourth immunisation, would be more effective in this population than a three dose schedule within a shorter interval without booster.

  • 19.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Ekholm, L
    Department of Paediatrics, Örebro University Hospital, Örebro, Sweden.
    Bodin, L
    Clinical Research Centre, Biostatistics and Epidemiology Unit, Örebro University Hospital, Örebro, Sweden.
    Breastfeeding enhances the antibody response to Hib and Pneumococcal serotype 6B and 14 after vaccination with conjugate vaccines2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 8, p. 1497-1502Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: This study was performed in order to investigate the relationship between breastfeeding and the antibody response after vaccination with conjugate vaccines against Hib and pneumococcal diseases. METHODS: This was an open non-randomised multi-centre study enrolling 101 healthy Swedish infants. PncCRM was administered concomitantly with DTaP/IPV/Hib at 3, 5, and 12 months at separate site. Duration of breastfeeding was calculated for days of almost exclusive as well as of total (any form of) breastfeeding. RESULTS: At 13 months of age 6 out of 83 children did not reach 0.2mug/ml against serotype 6B, and five of these were breastfed less than 90 days (Fisher's Exact test, P=0.011). Four children did not reach 1mug/ml against Hib and all those were breastfed less than 90 days (Fisher's Exact test, P=0.008). One month after the second dose, at 6 months of age, children breastfed 90 days or more showed significantly higher GMC against serotype 14 (P=0.003). CONCLUSION: This study indicates that children exclusively breastfed 90 days or more might get a better serological protection against Hib, and the pneumococcal serotypes 6B and 14 after vaccination, compared to children less breastfed.

  • 20.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Flodmark, Carl-Erik
    Rombo, Lars
    Tansey, Susan P.
    Sidhu, Mohinder
    Trammel, James
    Emini, Emilio A.
    Gruber, William C.
    Scott, Daniel A.
    Gurtman, Alejandra
    13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): A phase 3, open-label trial2013In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 31, no 9, p. 1284-1292Article in journal (Refereed)
    Abstract [en]

    Background: As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This open-label phase 3 study evaluated immunogenicity and safety of PCV13 in Swedish infants and toddlers previously given 1 or 2 doses of PCV7 during infancy. Methods: Healthy infants previously given PCV7 at ages 3 months (group 1; n = 118) or 3 and 5 months (group 2; n = 116) received PCV13 at ages 5 (group 1) and 12 months (both groups). IgG responses were assessed 1 month after each PCV13 dose and before the 12-month dose. Local reactions and systemic events were collected for 7 days postvaccination. Other adverse events were also collected. Results: Post-5-month dose, IgG geometric mean concentrations (GMCs) in group 1 were 1.56-4.70 mu g/ml for most PCV7 serotypes except 6B (0.40 mu g/ml) and 23F (0.57 mu g/ml) and 0.72-1.88 mu g/ml for most of the 6 additional serotypes, except 6A (0.28 mu g/ml). Post-12-month dose, IgG GMCs for the PCV7 serotypes were 2.93-9.63 mu g/ml (group 1) and 3.33-9.30 mu g/ml (group 2); and for the 6 additional serotypes, 1.85-14.65 mu g/ml (group 1) and 1.34-13.16 mu g/ml (group 2). GMCs increased by >4-fold in both groups from pre- to post-12-month dose. Proportions of subjects in group 1 with pneumococcal serotype-specific IgG concentrations >= 0.35 mu g/ml (WHO-designated postprimary reference antibody level) post-5-month dose were 92.2-99.1% for most PCV7 serotypes except 6B (53.0%) and 23F (62.6%) and 80.9-100.0% for most of the 6 additional serotypes except 6A (36.8%). Local reactions and fever were mostly mild or moderate. Conclusions: PCV13 was immunogenic and safe in infants and toddlers previously partially immunized with PCV7. Even a single dose in an infant or toddler induces an immune response to the 6 additional serotypes. (C) 2013 Published by Elsevier Ltd.

  • 21.
    Silfverdal, Sven-Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Icardi, Giancarlo
    Vesikari, Timo
    Flores, Sheryl A.
    Pagnoni, Marco F.
    Xu, Jin
    Liu, Frank
    Stek, Jon E.
    Boisnard, Florence
    Thomas, Stephane
    Ziani, Eddy
    Lee, Andrew W.
    A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months2016In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 34, no 33, p. 3810-3816Article in journal (Refereed)
    Abstract [en]

    Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational, fully-liquid, combination vaccine designed to protect against 6 infectious diseases, including 5 pertussis antigens and OMPC instead of PT as conjugated protein for Hib component.

    Methods: In this multicenter, double-blind, comparator-controlled, Phase III study (NCT01480258) conducted in Sweden, Italy, and Finland, healthy infants were randomized 1:1 to receive one two immunization regimens. The DTaP5-HB-IPV-Hib Group received the investigational hexavalent vaccine (DTaP5-HB-IPV-Hib) and the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11-12 months of age. Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4 months of age and PCV13 at 11-12 months. Subjects administered RV5 received a 3rd dose at 5 months of age.

    Results: A total of 656 subjects were randomized to the DTaP5-HB-IPV-Hib Group and 659 subjects to Control Group. Immune responses to all vaccine antigens post-toddler dose were non-inferior in the DTaP5-HB-IPV-Hib Group as compared to the Control Group. Additionally, the post-dose 2 and pre-toddler DTaP5-HB-IPV-Hib anti-PRP responses were superior. The DTaP5-HB-IPV-Hib Group responses to concomitant RV1 were non-inferior compared to the Control Group. Solicited adverse event rates after any dose were similar in both groups, except for higher rates of pyrexia (6.4% difference; 95% CI: 1.5,11.3) and somnolence (5.8% difference; 95% CI: 1.7,9.8) in the DTaP5-HB-IPV-Hib Group. Vaccine-related serious adverse events occurred infrequently in the DTaP5-HB-IPV-Hib Group (0.3%) and the Control Group (0.5%).

    Conclusions: The safety and immunogenicity of DTaP5-HB-IPV-Hib is generally comparable to Control when administered in the 2, 4, 11-12 month schedule. Early Hib responses were superior versus Control. DTaP5-HB-IPV-Hib could provide a new hexavalent option for pediatric combination vaccines, aligned with recommended immunizations in Europe.

  • 22. Tambyah, Paul A
    et al.
    Wilder-Smith, Annelies
    Institute of Public Health, University of Heidelberg, Germany.
    Pavlova, Borislava G
    Barrett, P Noel
    Oh, Helen M L
    Hui, David S
    Yuen, Kwok-yung
    Fritsch, Sandor
    Aichinger, Gerald
    Loew-Baselli, Alexandra
    van der Velden, Maikel
    Maritsch, Friedrich
    Kistner, Otfried
    Ehrlich, Hartmut J
    Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine.2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 2, p. 329-35Article in journal (Refereed)
    Abstract [en]

    A successful vaccine development strategy for areas with clustered H5N1 events requires conduct of vaccine trials in potentially non-naïve subjects and evaluation of post-vaccination responsiveness. An open-label, randomized, phase I/II study therefore assessed the immunogenicity and safety of two different dose levels of an inactivated, non-adjuvanted, whole virus clade 2.1 (A/Indonesia/05/2005) H5N1 Vero cell-derived influenza vaccine in healthy adults (21-45 years) from a region where the virus has been circulating (Hong Kong) as well as Singapore. Subjects (N=110) were randomized 1:1 to receive two vaccinations with either 3.75 μg or 7.5 μg H5N1 haemagglutinin antigen 21 days apart. Safety, immunogenicity (microneutralization [MN] and single radial haemolysis [SRH] at baseline and post-vaccination) and cross-reactivity against a heterologous clade 1 strain (A/Vietnam/1203/2004) of the vaccine were assessed. Pre-existing immunity to the vaccine strain was 14% which is higher than previously reported for these regions. Two vaccinations with either vaccine formulation induced high seroprotection rates (MN titre ≥ 1:20) against the vaccine strain A/Indonesia/05/2005: 82.7% and 86.5% in the 3.75 μg and 7.5 μg dose groups. Seroconversion rates and fold increase exceeded the CPMP criterion of >40% and >2.5 for MN and SRH in both dose groups after the second vaccination, while the seroprotection rate in the 7.5 μg dose group determined by SRH was only marginally lower (69.2%) than the CPMP criterion of >70%. Thus, 11 of 12 CHMP criteria were fulfilled. A cross-reactive antibody response against the heterologous A/Vietnam/1203/2004 strain was demonstrated after the second vaccination (>21% by MN and ≥ 25% by SRH). Persistence of antibodies against the vaccine strain was also demonstrated 6 months after the first vaccination, indicating that a booster vaccination would be effective in those who have received two priming doses. No serious adverse events were reported. The H5N1 influenza vaccine against clade 2.1 strain A/Indonesia/05/2005 was well tolerated and immunogenic after two vaccinations, and induced a cross-neutralizing antibody response, with no dose effect.

  • 23. Twine, Susan
    et al.
    Shen, Hua
    Harris, Gregory
    Chen, Wangxue
    Sjöstedt, Anders
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Clinical Bacteriology.
    Ryden, Patrik
    Umeå University, Faculty of Science and Technology, Department of Mathematics and Mathematical Statistics.
    Conlan, Wayne
    BALB/c mice, but not C57BL/6 mice immunized with a Delta clpB mutant of Francisella tularensis subspecies tularensis are protected against respiratory challenge with wild-type bacteria: Association of protection with post-vaccination and post-challenge immune responses2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 24, p. 3634-3645Article in journal (Refereed)
    Abstract [en]

    Francisella tularensis subspecies tularensis is highly virulent for humans especially when it is inhaled. Therefore, it has the potential to be used as a biothreat agent. Vaccines against F. tularensis will need to be approved in accordance with the FDA Animal Rule. This will require identification of robust correlates of protection in experimental animals and the demonstration that similar immune responses are generated in vaccinated humans. Towards this goal, we have developed an experimental live vaccine strain by deleting the gene, clpB, encoding a heat shock protein from virulent subsp. tularensis strain, SCHU S4. SCHU S4 Delta clpB administered intradermally protects BALB/c, but not C57BL/6 mice from subsequent respiratory challenge with wildtype SCHU S4. A comparison of post-vaccination and post-challenge immune responses in these two mouse strains shows an association between several antibody and cytokine responses and protection. In particular, elevated IFN gamma levels in the skin 2 days after vaccination, sero-conversion to hypothetical membrane protein ETT_778c, and to 30S ribosomal protein Si (FTT_0183c) of F. tularensis after 30 days of vaccination, and elevated levels of pulmonary IL-17 on day 7 after respiratory challenge with SCHU S4 were all associated with protection. (C) 2012 Wayne Conlan. Published by Elsevier Ltd. All rights reserved.

  • 24. Verguet, Stephane
    et al.
    Jassat, Waasila
    Hedberg, Calle
    Tollman, Stephen
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Jamison, Dean T.
    Hofman, Karen J.
    Measles control in Sub-Saharan Africa: South Africa as a case study2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 9, p. 1594-1600Article in journal (Refereed)
    Abstract [en]

    Background: Due to intensified measles immunization efforts, measles mortality has decreased substantially worldwide, particularly in Sub-Saharan Africa (SSA). The World Health Organization (WHO) estimated a 92% decrease in measles-related deaths in the WHO AFRO region for the period 2000-2008. Recently, the AFRO region established a measles pre-elimination goal and experts have suggested engaging in a measles eradication campaign at the global level. However, recent large-scale outbreaks in many Sub-Saharan African countries present a challenge to measles control efforts. This paper examines measles immunization and the impact of measles supplemental immunization activities (SlAs) on routine immunization coverage in South Africa (SA). Methods: We reported on immunization coverage trends in SA for the period 2001-2010 at the province and district levels. The data included routine immunization for 1st and 2nd doses of measles vaccine (MCV1, MCV2), SlAs, 1st dose of Bacille Calmette-Guerin vaccine, 1st and 3rd doses of oral polio vaccine (OPV1, OPV3), 3rd dose of Diphtheria-Tetanus-Pertussis-Haemophilus-influenzae-B vaccine (DTP-Hib3), and the number of under-one-year-olds having completed a primary course of immunization (Imm1). A regression model looked at the SIA impact on routine coverage. Results: Over the past decade, MCV1 and MCV2 coverage have increased nationally from 68% and 57% in 2001 to 95% and 83% in 2010, respectively. SIA coverage has remained at high levels, around 90%, over the same period. Substantial heterogeneity in MCV1 and MCV2 coverage is present across SA districts, with differences in coverage of 56% (MCV1) and 51% (MCV2) in 2010. In any given year, occurrence of SlAs was associated with a decrease in routine immunization coverage of MCV1, MCV2, OPV1, OPV3, DTP-Hib3, and Imm1, at the district level. Conclusions: The heterogeneity in measles vaccination coverage across SA districts challenges the goal of measles elimination in SA and SSA. The reduction in routine immunization coverage associated with the occurrence of SlAs raises the legitimate concern that SlAs may negatively impact health systems' functioning. (C) 2012 Elsevier Ltd. All rights reserved.

  • 25. Vesikari, Timo
    et al.
    Itzler, Robbin
    Karvonen, Aino
    Korhonen, Tiina
    Van Damme, Pierre
    Behre, Ulrich
    Bona, Gianni
    Gothefors, Leif
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Heaton, Penny M
    Dallas, Michael
    Goveia, Michelle G
    RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe2009In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 28, no 2, p. 345-351Article in journal (Refereed)
    Abstract [en]

    A pentavalent human-bovine reassortant oral rotavirus vaccine, RotaTeq, was evaluated among nearly 70,000 infants in the Rotavirus Efficacy and Safety Trial (REST), of which 30,523 were from Europe. All infants were followed for serious adverse events as well as hospitalizations and emergency department (ED) visits. All adverse events, health care utilization, and RVGE regardless of severity were evaluated in the clinical efficacy cohort (N=2686) in Finland. RotaTeq was 98.3% (95% CI, 90.2-100%) and 68.0% (95% CI 60.3-74.4%) efficacious against severe rotavirus gastroenteritis (RVGE) and all RVGE due to any serotype for two rotavirus seasons post-vaccination. The combined rate of hospitalizations and ED visits due to RVGE of any serotype was reduced by 94.5% (95% CI, 91.3-96.8%) for up to 2 years after vaccination. There were no statistically significant differences between RotaTeq and placebo for any of the safety outcomes. In Europe, RotaTeq was highly efficacious and well tolerated.

  • 26. Wallensten, Anders
    et al.
    Munster, Vincent J
    Karlsson, Malin
    Lundkvist, Ake
    Brytting, Mia
    Stervander, Martin
    Osterhaus, Albert D M E
    Fouchier, Ron A M
    Olsen, Björn
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    High prevalence of influenza A virus in ducks caught during spring migration through Sweden.2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 44-46, p. 6734-5Article in journal (Refereed)
    Abstract [en]

    As part of our ongoing screening of wild birds in Northern Europe, 358 mallards (Anas platyrhynchos) and 203 shelducks (Tadorna tadorna) were caught in southern Sweden during the spring 2003. Faecal samples were analyzed by real time RT-PCR for the presence of influenza A virus. In contrast to what has been found in North American studies; Eurasian spring migrating ducks passing through Sweden had a relatively high prevalence of influenza A virus.

  • 27.
    Wiström, Johan
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Ahlm, Clas
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Lundberg, Sonia
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Settergren, Bo
    Tärnvik, Arne
    Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Infectious Diseases.
    Booster vaccination with recombinant hepatitis B vaccine four years after priming with one single dose1999In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 17, no 17, p. 2162-2165Article in journal (Refereed)
    Abstract [en]

    We here studied the antibody response to a booster dose four years after the administration of one single dose of recombinant HB vaccine. Before receiving the booster dose, levels of protective antibodies (anti-HBs) were generally low and 24/41 (59%) individuals lacked detectable antibodies (< 1 IU/L). Within 14 d of booster vaccination, 36/38 (95%) vaccinees showed levels of antibodies > 100 IU/L. Notably, these levels were at least as high as those of a reference group 12 months after initiation of vaccination according to the standard three-dose vaccination at intervals of 0, 1 and 6 months. In conclusion, one single dose of HB vaccine seemed to confer on young healthy individuals a well preserved B cell memory, disclosed as a rapid and strong antibody response to a second dose four years later.

  • 28. Østergaard, Lars
    et al.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Berglund, Johan
    Flodmark, Carl-Erik
    West, Christina
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Bianco, Veronique
    Baine, Yaela
    Miller, Jacqueline M.
    A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: An open, randomised, controlled trial.2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 4, p. 774-783Article in journal (Refereed)
    Abstract [en]

    The co-administration of the tetravalent meningococcal conjugate vaccine, MenACWY-TT, with a licensed hepatitis A and B vaccine, HepA/B (Twinrix(®)), was compared to their separate administration in this open, randomised, controlled study. Healthy subjects 11-17 years of age (n=611) were randomised (3:1:1) to receive both vaccines, MenACWY-TT alone or HepA/B alone. The co-administration of both vaccines was shown to be non-inferior to their individual administration. At seven months after the first vaccination, 99.4-100% of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1% of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity, safety and reactogenicity of either of the vaccines.

1 - 28 of 28
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