Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
07/2023
Journal Article
Authors:
El Sahly, H. M.;
Yildirim, I.;
Frey, S. E.;
Winokur, P.;
Jackson, L. A.;
Bernstein, D. I.;
Creech, C. B.;
Chen, W. H.;
Rupp, R. E.;
Whitaker, J. A.;
Phadke, V.;
Hoft, D. F.;
Ince, D.;
Brady, R. C.;
Edwards, K. M.;
Ortiz, J. R.;
Berman, M. A.;
Weiss, J.;
Wegel, A.;
Dmid Study Group
Journal:
J Infect Dis
PMID:
37466221
URL:
https://www.ncbi.nlm.nih.gov/pubmed/37466221
Keywords:
avian influenza influenza A(H7N9) pandemic pandemic preparedness
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 x 2 Group), MIV with AS03 (AS03 x 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 one 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 (Neut) antibody assays. RESULTS: We enrolled 304 participants: 153 received the adjuvanted boost, and 151 received the unadjuvanted boost. At 21 days post vaccination, 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 x 2 Group, 89% and 75% in AS03 x 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.
