title: Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial.
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®-adjuvanted vaccine (Focetria®) in H1N1pnd09-naïve 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 [1∶1∶1] controlled clinical trial in pregnant women after gestational week 20: (1) 7.5 µg H1N1pnd09 antigen with MF59-adjuvant (Pa7.5 µg); (2) 3.75 µg antigen half MF59-adjuvanted (Pa3.75 µg); (3) 15 µg antigen unadjuvanted (P15 µg); and in non-pregnant women receiving (4) 7.5 µg antigen full adjuvanted (NPa7.5 µg). 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 µg and 149 non-pregnant women were recruited to NPa7.5 µg. The sero-conversion rate was significantly increased in non-pregnant (NPa7.5 µg) compared with pregnant (Pa7.5 µg) 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 µg) and non-pregnant (NPa7.5 µg) groups (OR = 0.49 [0.13-1.85], p = 0.29).
  
  
  CONCLUSIONS
  Our study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01012557.
authors: Copenhagen Prospective Studies on Asthma in Childhood (COPSAC), Health Sciences, University of Copenhagen, Copenhagen University Hospital, Gentofte, Denmark.
authors: Anne Louise
authors: AL
authors: Bischoff
authors: Nilofar Vahman
authors: NV
authors: Følsgaard
authors: Charlotte Giwercman
authors: CG
authors: Carson
authors: Jakob
authors: J
authors: Stokholm
authors: Louise
authors: L
authors: Pedersen
authors: Maria
authors: M
authors: Holmberg
authors: Amalie
authors: A
authors: Bisgaard
authors: Sune
authors: S
authors: Birch
authors: Theodore F
authors: TF
authors: Tsai
authors: Hans
authors: H
authors: Bisgaard
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D011136:Polysorbates; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011446:Prospective Studies; D016036:Seroepidemiologic Studies; D013185:Squalene; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; C558220:focetria; D013185:Squalene
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