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Title
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Safety and immunogenicity of 3 formulations of an investigational respiratory syncytial virus vaccine in nonpregnant women : results from 2 phase 2 trials
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Author
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Abstract
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| Background. Respiratory syncytial virus (RSV) causes bronchiolitis and pneumonia in neonates and infants. RSV vaccination during pregnancy could boost preexisting neutralizing antibody titers, providing passive protection to newborns. Methods. Two observer-blinded, controlled studies (RSV F-020 [clinical trials registration NCT02360475] and RSV F-024 [NCT02753413]) evaluated immunogenicity and safety of an investigational RSV vaccine in healthy, nonpregnant 18-45-year-old women. Both studies used a licensed adult formulation of combined tetanus toxoid-diphtheria toxoid-acellular pertussis (Tdap) vaccine as a control. RSV F-020 evaluated immunogenicity and safety: participants were randomized (1:1:1:1) to receive 1 dose of RSV-prefusion F protein (PreF) vaccine containing 30 mu g or 60 mu g of nonadjuvanted RSV-PreF, 60 mu g of aluminum-adjuvanted RSV-PreF, or Tdap. RSV F-024 evaluated safety: participants were randomized 1:1 to receive 1 dose of 60 mu g of nonadjuvanted RSV-PreF or Tdap. Results. Both studies showed similar reactogenicity profiles for RSV-PreF and Tdap. No serious adverse events were considered vaccine related. In RSV F-020, geometric mean ratios of RSV-A neutralizing antibody levels at day 30 versus prevaccination were 3.1-3.9 in RSV-PreF recipients and 0.9 in controls. Palivizumab-competing antibody concentrations increased > 14-fold in RSV-PreF recipients on day 30. RSV antibody titers waned after day 30 but remained well above baseline through day 90. Conclusions. All formulations of RSV-PreF boosted preexisting immune responses in 18-45-year old women with comparable immunogenicity. The RSV-PreF safety profile was similar to that of Tdap vaccine. |
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Language
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English
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Source (journal)
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The journal of infectious diseases. - Chicago, Ill.
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Publication
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Chicago, Ill.
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2018
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ISSN
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0022-1899
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DOI
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10.1093/INFDIS/JIY065
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Volume/pages
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217
:10
(2018)
, p. 1616-1625
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ISI
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000430729800016
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Full text (Publisher's DOI)
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Full text (open access)
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