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Silfverdal, Sven-Arne
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Publications (10 of 70) Show all publications
Gustafsson, A. M., Fransson, E., Dubicke, A., Hjelmstedt, A. K., Ekman-Ordeberg, G., Silfverdal, S.-A., . . . Bohlin, K. (2018). Low levels of anti-secretory factor in placenta are associated with preterm birth and inflammation. Acta Obstetricia et Gynecologica Scandinavica, 97(3), 349-356
Open this publication in new window or tab >>Low levels of anti-secretory factor in placenta are associated with preterm birth and inflammation
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2018 (English)In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 97, no 3, p. 349-356Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: Anti-secretory factor is a protein that regulates secretory and inflammatory processes and preterm birth is associated with inflammation. Therefore, our hypothesis was that anti-secretory factor might play a role in immune reactivity and homeostasis during pregnancy.

MATERIAL AND METHODS: Following spontaneous onset of labor and preterm or term delivery, placenta biopsies were collected. The levels of anti-secretory factor and markers of inflammation (CD68, CD163) and vascularization (CD34, smooth muscle actin) were analyzed by immunohistochemistry.

RESULTS: The 61 placental biopsies included 31 preterm (<37 weeks of gestation) and 30 term (37-41 weeks) samples. The preterm placentas exhibited lower levels of anti-secretory factor (p = 0.008) and larger numbers of CD68-positive cells (p < 0.001) compared to term. Preterm placentas had blood vessel of smaller diameter (p = 0.036) indicative of immaturity. The level of interleukin-6 in cord blood was higher after very preterm than term birth, suggesting a fetal inflammatory response. The placenta level of anti-secretory factor was positively correlated to the length of gestation (p = 0.025) and negatively correlated to the levels of the inflammatory markers CD68 (p = 0.015) and CD163 (p = 0.028).

CONCLUSIONS: Preterm delivery is associated with low levels of anti-secretory factor in placenta. Inflammation, a potential trigger of preterm birth, is more pronounced in the preterm placenta and inversely related to the placental level of anti-secretory factor, suggesting both a link and a potential target for intervention.

Place, publisher, year, edition, pages
Wiley-Blackwell, 2018
Keywords
Anti-secretory factor, inflammation, placenta, preterm birth, vascularization
National Category
Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:umu:diva-146059 (URN)10.1111/aogs.13282 (DOI)000426055500014 ()29265188 (PubMedID)
Available from: 2018-05-03 Created: 2018-05-03 Last updated: 2018-06-09Bibliographically approved
Gustafsson, A., Granström, E., Stecksén-Blicks, C., West, C. E. & Silfverdal, S.-A. (2018). The Antisecretory Factor in Plasma and Breast Milk in Breastfeeding Mothers: A Prospective Cohort Study in Sweden. Nutrients, 10(9), Article ID 1227.
Open this publication in new window or tab >>The Antisecretory Factor in Plasma and Breast Milk in Breastfeeding Mothers: A Prospective Cohort Study in Sweden
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2018 (English)In: Nutrients, ISSN 2072-6643, E-ISSN 2072-6643, Vol. 10, no 9, article id 1227Article in journal (Refereed) Published
Abstract [en]

Inflammation and infection postpartum threaten the mother and her infant. Human milk provides a defense for the infant, but inflammatory complications like mastitis may lead to the cessation of breastfeeding. Antisecretory factor (AF) has a role in the regulation of secretory processes and inflammation. The objective of the study was to describe AF-levels in plasma and breast milk, and in relation to breast complications. Breastfeeding mothers (n = 95) were consecutively recruited at a Well Baby Clinic in Umeå, Sweden. At inclusion four weeks postpartum, samples of venous blood (10 mL) and breast milk (10 mL) were collected. Active AF was analyzed with ELISA using a monoclonal antibody mAb43, and was detected in all samples of plasma and breast milk with a positive correlation (Spearman coefficient = 0.40, p < 0.001; Pearson correlation = 0.34, p < 0.01). High AF-levels in plasma correlated with high AF-levels in breast milk. The results suggest a co-regulation between active AF in plasma and breastmilk, and/or a local regulation of AF in the breast. Further studies are needed to determine the pathways for the activation of AF-levels in breast milk and plasma.

Place, publisher, year, edition, pages
MDPI, 2018
Keywords
antisecretory factor, breast milk, breastfeeding, candida, human milk, inflammation, lactoferrin
National Category
Pediatrics Nutrition and Dietetics
Identifiers
urn:nbn:se:umu:diva-151722 (URN)10.3390/nu10091227 (DOI)30181494 (PubMedID)2-s2.0-85053077078 (Scopus ID)
Available from: 2018-09-11 Created: 2018-09-11 Last updated: 2018-10-10Bibliographically approved
Åkeson, P. K., Åkesson, K. E., Lind, T., Hernell, O., Silfverdal, S.-A. & Öhlund, I. (2018). Vitamin D Intervention and Bone: A Randomized Clinical Trial in Fair- and Dark-skinned Children at Northern Latitudes. Journal of Pediatric Gastroenterology and Nutrition - JPGN, 67(3), 388-394
Open this publication in new window or tab >>Vitamin D Intervention and Bone: A Randomized Clinical Trial in Fair- and Dark-skinned Children at Northern Latitudes
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2018 (English)In: Journal of Pediatric Gastroenterology and Nutrition - JPGN, ISSN 0277-2116, E-ISSN 1536-4801, Vol. 67, no 3, p. 388-394Article in journal (Refereed) Published
Abstract [en]

Objectives: The aim of the study was to evaluate vitamin D status and effects of vitamin D intervention on bone mineral density (BMD) and content (BMC) in children with fair and dark skin in Sweden during winter.

Methods: In a 2-center prospective double-blinded randomized intervention study 5- to 7-year-old children (n = 206) with fair and dark skin in Sweden (55 degrees N-63 degrees N) received daily vitamin D supplements of 25 mu g, 10 mu g, or placebo (2 mu g) during 3 winter months. We measured BMD and BMC for total body (TB), total body less head (TBLH), femoral neck (FN), and spine at baseline and 4 months later. Intake of vitamin D and calcium, serum 25-hydroxy vitamin D (S-25 [OH]D), and related parameters were analyzed.

Results: Despite lower S-25(OH)D in dark than fair-skinned children, BMD of TB (P = 0.012) and TBLH (P = 0.002) and BMC of TBLH (P = 0.04) were higher at baseline and follow-up in those with dark skin. Delta (Delta) BMD and BMC of TB and TBLH did not differ between intervention and placebo groups, but FN-BMC increased more among dark-skinned children in the 25 mu g (P = 0.038) and 10 mu g (P = 0.027) groups compared to placebo. We found no associations between Delta S-25(OH)D, P-parathyroid hormone, P-alkaline phosphatase, and Delta BMD and BMC, respectively.

Conclusions: BMD and BMC remained higher in dark- than fair-skinned children despite lower vitamin D status. Even though no difference in general was found in BMD or BMC after vitamin D intervention, the increase in FN-BMC in dark-skinned children may suggest an influence on bone in those with initially insufficient vitamin D status.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2018
Keywords
bone mineral content, bone mineral density, child, 25-hydroxyvitamin D, skin color
National Category
Orthopaedics Pediatrics
Identifiers
urn:nbn:se:umu:diva-152216 (URN)10.1097/MPG.0000000000002031 (DOI)000442252100024 ()29851760 (PubMedID)
Available from: 2018-10-25 Created: 2018-10-25 Last updated: 2018-10-25Bibliographically approved
Vesikari, T., Silfverdal, S.-A., Jordanov, E. & Feroldi, E. (2017). A Randomized, Controlled Study of DTaP-IPV-HB-PRP-T, a Fully Liquid Hexavalent Vaccine, Administered in a 3-,5-and 11-to 12-month Schedule. The Pediatric Infectious Disease Journal, 36(1), 87-93
Open this publication in new window or tab >>A Randomized, Controlled Study of DTaP-IPV-HB-PRP-T, a Fully Liquid Hexavalent Vaccine, Administered in a 3-,5-and 11-to 12-month Schedule
2017 (English)In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 36, no 1, p. 87-93Article in journal (Refereed) Published
Abstract [en]

Background: To assess the immunogenicity and safety of a fully liquid, ready-to-use hexavalent DTaP-IPV-HB-PRP-T vaccine when administered in a 2 + 1 schedule at 3, 5 and 11-12 months of age.

Methods: Phase III, randomized, active-controlled, observer-blind, multi-center study. Infants were randomized to receive DTaP-IPV-HB-PRP-T (N = 275) or a licensed control hexavalent vaccine (DTaP-IPV-HB//PRPNT: N = 275), both given in coadministration with Prevenar 13. Serum was analyzed for immune responses to all vaccine antigens. Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was tested at completion of the primary series using predefined seroprotection (SP) rate and vaccine response (VR) rates. Safety was assessed using parental reports.

Results: Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was demonstrated postdose 3 for each antigen, and the SP (for D, T, poliovirus 1, 2 and 3, hepatitis B and polyribosylribitol phosphate) and VR rates (for pertussis toxin and filamentous hemagglutinin) were high in each group. SP rates for D, T, polio 1, 2, 3 and VR rates for pertussis toxin and filamentous hemagglutinin were similar in each group. For hepatitis B, SP rate was slightly higher for DTaP-IPV-HB//PRP similar to T (99.6%) than DTaP-IPV-HB-PRP-T (96.4%), and for PRP, SP rate was higher for DTaP-IPV-HB-PRP-T (93.5%) than DTaP-IPV-HB//PRP similar to T (85.2%). For Prevenar 13, the SP rate was high for each serotype and similar for both groups. All vaccines were well tolerated.

Conclusions: These study findings confirm the safety and immunogenicity and thus the suitability of this fully liquid hexavalent vaccine for administration in a 2 + 1 schedule.

Keywords
hexavalent vaccine, 2+1 schedule, immunogenicity, safety
National Category
Pediatrics Immunology in the medical area
Identifiers
urn:nbn:se:umu:diva-131092 (URN)10.1097/INF.0000000000001358 (DOI)000391259900021 ()
Available from: 2017-02-15 Created: 2017-02-15 Last updated: 2018-06-09Bibliographically approved
Öhlund, I., Lind, T., Hernell, O., Silfverdal, S.-A. & Karlsland Åkeson, P. (2017). Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial. American Journal of Clinical Nutrition, 106(1), 105-112
Open this publication in new window or tab >>Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial
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2017 (English)In: American Journal of Clinical Nutrition, ISSN 0002-9165, E-ISSN 1938-3207, Vol. 106, no 1, p. 105-112Article in journal (Refereed) Published
Abstract [en]

Background: Dark skin and low exposure to sunlight increase the risk of vitamin D insufficiency in children. Objective: The aim of the study was to evaluate the amount of vitamin D needed to ascertain that most children >4 y of age attain sufficient serum25-hydroxyvitamin D [S-25(OH) D; i.e., >= 50 nmol/L] during winter regardless of latitude and skin color. Design: In a longitudinal, double-blind, randomized, food-based intervention study, 5- to 7-y-old children from northern (638 degrees N) and southern (558 degrees N) Sweden with fair (n = 108) and dark (n = 98) skin were included. Children, stratified by skin color by using Fitzpa-trick's definition, were randomly assigned to receive milk-based vitamin D-3 supplements that provided 2 (placebo), 10, or 25 mu g/d during 3 winter months. Results: Mean daily vitamin D intake increased from 6 to 17 mu g and 26 mu g in the intervention groups supplemented with 10 and 25 mu g, respectively. In the intention-to-treat analysis, 90.2% (95% CI: 81.1%, 99.3%) of fair-skinned children randomly assigned to supplementation of 10 mu g/d attained sufficient concentrations, whereas 25 mu g/d was needed in dark-skinned children to reach sufficiency in 95.1% (95% CI: 88.5%, 100%). In children adherent to the study product, 97% (95% CI: 91.3%, 100%) and 87.9% (95% CI: 76.8%, 99%) of fair-and dark-skinned children, respectively, achieved sufficient concentrations if supplemented with 10 mu g/d. By using 95% prediction intervals for 30 and 50 nmol S-25(OH) D/L, intakes of 6 and 20 mu g/d are required in fair-skinned children, whereas 14 and 28 mu g/d are required in children with dark skin. Conclusion: Children with fair and dark skin require vitamin D intakes of 20 and 28 mu g/d, respectively, to maintain S-25(OH) D >= 50 nmol/L, whereas intakes of 6 and 14 mu g/d, respectively, are required to maintain concentrations >= 30 nmol/L during winter.

Place, publisher, year, edition, pages
American Society for Nutrition, 2017
Keywords
serum 25-hydroxyvitamin D, intervention, season, latitude, vitamin D, child
National Category
Pediatrics Nutrition and Dietetics
Identifiers
urn:nbn:se:umu:diva-138554 (URN)10.3945/ajcn.116.147108 (DOI)000404593900015 ()28615261 (PubMedID)
Available from: 2017-09-14 Created: 2017-09-14 Last updated: 2018-06-09Bibliographically approved
Vaezghasemi, M., Sundberg, L., Ivarsson, A., Eurenius, E., Silfverdal, S. A. & Lindkvist, M. (2017). Psychometric analysis of Age and Stages Questionnaire: Social-Emotional (ASQ:SE) among 3-year-olds. Paper presented at 10th European Public Health Conference Sustaining resilient and healthy communities Stockholm, Sweden 1–4 November 2017. European Journal of Public Health, 27(Suppl_3), 173-174
Open this publication in new window or tab >>Psychometric analysis of Age and Stages Questionnaire: Social-Emotional (ASQ:SE) among 3-year-olds
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2017 (English)In: European Journal of Public Health, ISSN 1101-1262, E-ISSN 1464-360X, Vol. 27, no Suppl_3, p. 173-174Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Mental health is an urgent public health challenge, and for some individuals the problem starts already in pre-school age. Increased knowledge is needed to guide evidence-based health-promoting interventions and early identification for adequate parental support. Valid and reliable instruments to measure children’s mental health are called for. Our aim is to analyze psychometric properties of the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) among 3-year-olds.

Methods: Within Child Health Care (CHC) in Västerbotten (Sweden) the 3-year-olds’ health check-up includes parent-rated socio-emotional health by scoring the ASQ:SE. This instrument has seven psychological domains (self-regulation, compliance, communication, adaptive functioning, autonomy, affect, and interaction); built up by 31 items, responded on a 3-point Likert scale with total scores 0-465. Item scores are combined into a total score with high values indicating social-emotional vulnerability. Most parents give informed consent for research and the study has ethical approval.

Results: During 2014-2016 we have ASQ:SE responses for 5434 children having had their 3-year health check-up (boys=2802, girls=2632), with total scores 0-215. Generally, boys scored higher (mean 31, SD 24; median 25) than girls (mean 25, SD 21; median 20), and 12% of boys, compared to 6% of girls, scored above the cut-off value (59). The internal consistency based on Cronbach’s alpha was 0.78. Confirmatory factor analysis was done and normative values were also reported for the ASQ:SE.

Conclusions: Our psychometric analyses of ASQ:SE among 3-year-olds indicates the relevance of an instrument for screening pre-school children’s social and emotional health. This is promising for future use of the instrument within ordinary CHC in Västerbotten and elsewhere.

Key messages:

  • The ASQ:SE instrument is a valuable asset within CHC to increase awareness about 3-year-olds social-emotional health.
  • The ASQ:SE instrument is a promising tool for low-cost screening of early social-emotional vulnerability.
Place, publisher, year, edition, pages
OXFORD UNIV PRESS, 2017
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
urn:nbn:se:umu:diva-143146 (URN)10.1093/eurpub/ckx187.443 (DOI)000414389801209 ()
Conference
10th European Public Health Conference Sustaining resilient and healthy communities Stockholm, Sweden 1–4 November 2017
Available from: 2017-12-20 Created: 2017-12-20 Last updated: 2018-06-09Bibliographically approved
Silfverdal, S. A., Coremans, V., Francois, N., Borys, D. & Cleerbout, J. (2017). Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Review of Vaccines, 16(2), 109-121
Open this publication in new window or tab >>Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)
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2017 (English)In: Expert Review of Vaccines, ISSN 1476-0584, E-ISSN 1744-8395, Vol. 16, no 2, p. 109-121Article, review/survey (Refereed) Published
Abstract [en]

Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.

Place, publisher, year, edition, pages
Taylor & Francis, 2017
Keywords
Pneumococcal conjugate vaccine, PHiD-CV, pneumococcal disease, safety, reactogenicity, adverse events, children, infants, clinical trial, post-licensure
National Category
Immunology in the medical area
Identifiers
urn:nbn:se:umu:diva-132132 (URN)10.1586/14760584.2016.1164044 (DOI)000392988900004 ()26954689 (PubMedID)
Available from: 2017-03-09 Created: 2017-03-09 Last updated: 2018-06-09Bibliographically approved
Prymula, R., Szenborn, L., Silfverdal, S.-A., Wysocki, J., Albrecht, P., Traskine, M., . . . Borys, D. (2017). Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: results from a randomized phase II study in infants. Vaccine, 35(35B), 4603-4611
Open this publication in new window or tab >>Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: results from a randomized phase II study in infants
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2017 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 35, no 35B, p. 4603-4611Article in journal (Refereed) Published
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. 

Place, publisher, year, edition, pages
ELSEVIER SCI LTD, 2017
Keywords
Pneumococcal protein, dPly, PhtD, PIED-CV vaccination, Reactogenicity, Immunogenicity, Infants
National Category
Pediatrics Infectious Medicine
Identifiers
urn:nbn:se:umu:diva-140058 (URN)10.1016/j.vaccine.2017.07.008 (DOI)000410017500019 ()28729019 (PubMedID)
Available from: 2017-10-09 Created: 2017-10-09 Last updated: 2018-06-09Bibliographically approved
Hasslöf, P., Karlsson Videhult, F., Silfverdal, S. A., West, C. E. & Stecksén-Blicks, C. (2017). Vitamin D Insufficiency among Women Post-Partum in Northern Sweden: A Public Health Concern. Food and Nutrition Sciences (8), 99-109
Open this publication in new window or tab >>Vitamin D Insufficiency among Women Post-Partum in Northern Sweden: A Public Health Concern
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2017 (English)In: Food and Nutrition Sciences, ISSN 2157-944X, E-ISSN 2157-9458, no 8, p. 99-109Article in journal (Refereed) Published
Abstract [en]

Pregnancy and post-partum represent a period of susceptibility for vitamin D insufficiency. This study investigated S-25 [OH] D levels in women in northern Sweden 4 weeks post-partum and its association with selected background factors. Blood from 100 healthy women were analyzed for iron status and serum levels of S-25[OH] D using ionization-mass spectrometry (HPLC-APCI-MS). <50 nmol/L was categorized as insufficiency and <25 nmol/L as deficiency. Maternal BMI, dietary habits, fungal infections during pregnancy, and infant birth characteristics were collected using questionnaires and medical charts. 58% were vitamin D insufficient whereas 10% had deficiency. Insufficiency was most common during winter (OR = 2.77; 95% CI = 1.1-6.96) and women with deficiency reported lower milk consumption; 11.3 ± 22.8 intakes per months vs. 34.0 ± 28.9 for those above 25 nmol/L (p < 0.05). Vitamin D-insufficient women had lower serum ferritin levels (p < 0.01) and higher serum transferrin levels (p < 0.05). A history of vaginal fungal infection during pregnancy was associated with insufficiency (OR = 5.10; 95% CI = 1.01-25.73), however, the confidence interval of the estimate was wide, resulting in uncertainty. It is concluded that vitamin D insufficiency 4 weeks post-partum was common in women living at 63°49'N. The odds of being insufficient were increased during winter whereas milk consumption was negatively associated with deficiency. The low vitamin D-levels particularly during winter is a public health concern. From a public health perspective it has to be considered whether dietary advices alone should be modified or if supplementation with vitamin D during pregnancy and the post-partum period also is needed.

Place, publisher, year, edition, pages
Scientific Research Publishing, 2017
Keywords
Vitamin D Insufficiency, Fungal Infection, Postpartum, Public Health, Season
National Category
Nutrition and Dietetics
Identifiers
urn:nbn:se:umu:diva-130490 (URN)10.4236/fns.2017.81007 (DOI)
Available from: 2017-01-20 Created: 2017-01-20 Last updated: 2018-06-09Bibliographically approved
Silfverdal, S.-A., Icardi, G., Vesikari, T., Flores, S. A., Pagnoni, M. F., Xu, J., . . . Lee, A. W. (2016). A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine, 34(33), 3810-3816
Open this publication in new window or tab >>A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months
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2016 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 34, no 33, p. 3810-3816Article in journal (Refereed) Published
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.

Keywords
DTaP, Polio, Hib, Hepatitis B, Hexavalent, Vaccine, Safety, Immunogenicity
National Category
Pediatrics
Identifiers
urn:nbn:se:umu:diva-125589 (URN)10.1016/j.vaccine.2016.05.054 (DOI)000380418600017 ()27288217 (PubMedID)
Available from: 2016-09-23 Created: 2016-09-13 Last updated: 2018-06-07Bibliographically approved
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