1. Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial.
- Author
-
Sahly, Hana M El, 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, and Group, DMID 17-0090 Study
- Subjects
AVIAN influenza ,CLINICAL trials ,IMMUNE response ,CLINICAL trial registries ,ANTIBODY titer - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF