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Author Bischoff, A.L.; Folsgaard, N.V.; Carson, C.G.; Stokholm, J.; Pedersen, L.; Holmberg, M.; Bisgaard, A.; Birch, S.; Tsai, T.F.; Bisgaard, H. url  doi
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  Title Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial Type Journal Article
  Year (down) 2013 Publication PloS one Abbreviated Journal PLoS One  
  Volume 8 Issue 4 Pages e56700  
  Keywords Adjuvants, Immunologic; Adult; Female; Humans; Influenza A Virus, H1N1 Subtype/*immunology; Influenza Vaccines/*administration & dosage/adverse effects/immunology; Influenza, Human/*prevention & control; Polysorbates; Pregnancy; Pregnancy Complications, Infectious/*prevention & control; Prospective Studies; Seroepidemiologic Studies; Squalene; Vaccination  
  Abstract BACKGROUND: Pregnant women were suspected to be at particular risk when H1N1pnd09 influenza became pandemic in 2009. Our primary objective was to compare the immune responses conferred by MF59(R)-adjuvanted vaccine (Focetria(R)) in H1N1pnd09-naive pregnant and non-pregnant women. The secondary aims were to compare influences of dose and adjuvant on the immune response. METHODS: The study was nested in the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC2010) pregnancy cohort in 2009-2010 and conducted as a single-blinded block-randomised [1ratio1ratio1] controlled clinical trial in pregnant women after gestational week 20: (1) 7.5 microg H1N1pnd09 antigen with MF59-adjuvant (Pa7.5 microg); (2) 3.75 microg antigen half MF59-adjuvanted (Pa3.75 microg); (3) 15 microg antigen unadjuvanted (P15 microg); and in non-pregnant women receiving (4) 7.5 microg antigen full adjuvanted (NPa7.5 microg). Blood samples were collected at baseline, 3 weeks, 3 and 10 months after vaccination, adverse events were recorded prospectively. RESULTS: 58 pregnant women were allocated to Pa7.5 microg and 149 non-pregnant women were recruited to NPa7.5 microg. The sero-conversion rate was significantly increased in non-pregnant (NPa7.5 microg) compared with pregnant (Pa7.5 microg) women (OR = 2.48 [1.03-5.95], p = 0.04) and geometric mean titers trended towards being higher, but this difference was not statistically significant (ratio 1.27 [0.85-1.93], p = 0.23). The significant titer increase rate showed no difference between pregnant (Pa7.5 microg) and non-pregnant (NPa7.5 microg) groups (OR = 0.49 [0.13-1.85], p = 0.29). CONCLUSION: Our study suggests the immune response to the 7.5 microg MF59-adjuvanted Focetria(R) H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women. TRIAL REGISTRATION: ClinicalTrials.gov NCT01012557.  
  Address Copenhagen Prospective Studies on Asthma in Childhood (COPSAC), Health Sciences, University of Copenhagen, Copenhagen University Hospital, Gentofte, Denmark  
  Corporate Author Thesis  
  Impact Factor 03,234 First Author Bischoff, A.L. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Bisgaard, H.  
  ISSN 1932-6203 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:23637733; PMCID:PMC3630160 Approved no  
  Call Number Serial 93  
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