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El Sahly, Hana M; Yildirim, Inci; Frey, Sharon E; Winokur, Patricia; Jackson, Lisa A; Bernstein, David I; Creech, C Buddy; Chen, Wilbur H; Rupp, Richard E; Whitaker, Jennifer A; Phadke, Varun; Hoft, Daniel F; Ince, Dilek; Brady, Rebecca C; Edwards, Kathryn M; Ortiz, Justin R; Berman, Megan A; Weiss, Julia; Wegel, Ashley; Keitel, Wendy A; Atmar, Robert L; Rostad, Christina A; Rouphael, Nadine; Anderson, Evan J; [...]

Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial

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  • Media type: E-Article
  • Title: Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
  • Contributor: El Sahly, Hana M; Yildirim, Inci; Frey, Sharon E; Winokur, Patricia; Jackson, Lisa A; Bernstein, David I; Creech, C Buddy; Chen, Wilbur H; Rupp, Richard E; Whitaker, Jennifer A; Phadke, Varun; Hoft, Daniel F; Ince, Dilek; Brady, Rebecca C; Edwards, Kathryn M; Ortiz, Justin R; Berman, Megan A; Weiss, Julia; Wegel, Ashley; Keitel, Wendy A; Atmar, Robert L; Rostad, Christina A; Rouphael, Nadine; Anderson, Evan J; [...]
  • Published: Oxford University Press (OUP), 2024
  • Published in: The Journal of Infectious Diseases, 229 (2024) 2, Seite 327-340
  • Language: English
  • DOI: 10.1093/infdis/jiad276
  • ISSN: 1537-6613; 0022-1899
  • Origination:
  • Footnote:
  • Description: Abstract Background Influenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown. Methods We recruited participants who had received monovalent inactivated A/Shanghai/2/2013 (H7N9) vaccine (MIV) approximately 5 years earlier, as follows: MIV with MF59 (MF59 × 2 group), MIV with AS03 (AS03 × 2 group), unadjuvanted MIV (No Adj group), MIV with MF59 or AS03 followed by unadjuvanted MIV (Adjx1 group), and A/H7-naive (unprimed group). Participants were randomized to receive 1 dose of AS03-adjuvanted or unadjuvanted A/Hong Kong/125/2017 (H7N9) MIV and were followed for safety and immunogenicity using hemagglutination inhibition (HAI) and neutralizing antibody assays. Results We enrolled 304 participants: 153 received the adjuvanted boost and 151 received the unadjuvanted boost. At 21 days postvaccination, the proportion of participants with HAI antibody titers against the boosting vaccine strain of ≥40 in the adjuvanted and unadjuvanted arms, respectively, were 88% and 49% in MF59 × 2 group, 89% and 75% in AS03 × 2 group, 59% and 20% in No Adj group, 94% and 55% in Adjx1group, and 9% and 11% in unprimed group. Conclusions Serologic responses to a heterologous A(H7N9) MIV boost were highest in participants primed and boosted with adjuvant-containing regimens. Clinical Trials Registration NCT03738241.