tetano
Editor, Senior Moderator
J Infect Dis
. 2023 Jul 19;jiad276.
doi: 10.1093/infdis/jiad276. Online ahead of print. Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
Hana M El Sahly[SUP] 1 [/SUP], Inci Yildirim[SUP] 2 [/SUP], Sharon E Frey[SUP] 3 [/SUP], Patricia Winokur[SUP] 4 [/SUP], Lisa A Jackson[SUP] 5 [/SUP], David I Bernstein[SUP] 6 [/SUP], C Buddy Creech[SUP] 7 [/SUP], Wilbur H Chen[SUP] 8 [/SUP], Richard E Rupp[SUP] 9 [/SUP], Jennifer A Whitaker[SUP] 1 [/SUP], Varun Phadke[SUP] 10 [/SUP], Daniel F Hoft[SUP] 3 [/SUP], Dilek Ince[SUP] 4 [/SUP], Rebecca C Brady[SUP] 6 [/SUP], Kathryn M Edwards[SUP] 7 [/SUP], Justin R Ortiz[SUP] 8 [/SUP], Megan A Berman[SUP] 9 [/SUP], Julia Weiss[SUP] 11 [/SUP], Ashley Wegel[SUP] 11 [/SUP]; DMID 17-0090 Study Group
Collaborators, Affiliations
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-naïve (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 × 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.
Keywords: avian influenza; influenza A(H7N9); pandemic; pandemic preparedness.
. 2023 Jul 19;jiad276.
doi: 10.1093/infdis/jiad276. Online ahead of print. Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
Hana M El Sahly[SUP] 1 [/SUP], Inci Yildirim[SUP] 2 [/SUP], Sharon E Frey[SUP] 3 [/SUP], Patricia Winokur[SUP] 4 [/SUP], Lisa A Jackson[SUP] 5 [/SUP], David I Bernstein[SUP] 6 [/SUP], C Buddy Creech[SUP] 7 [/SUP], Wilbur H Chen[SUP] 8 [/SUP], Richard E Rupp[SUP] 9 [/SUP], Jennifer A Whitaker[SUP] 1 [/SUP], Varun Phadke[SUP] 10 [/SUP], Daniel F Hoft[SUP] 3 [/SUP], Dilek Ince[SUP] 4 [/SUP], Rebecca C Brady[SUP] 6 [/SUP], Kathryn M Edwards[SUP] 7 [/SUP], Justin R Ortiz[SUP] 8 [/SUP], Megan A Berman[SUP] 9 [/SUP], Julia Weiss[SUP] 11 [/SUP], Ashley Wegel[SUP] 11 [/SUP]; DMID 17-0090 Study Group
Collaborators, Affiliations
- PMID: 37466221
- DOI: 10.1093/infdis/jiad276
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-naïve (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 × 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.
Keywords: avian influenza; influenza A(H7N9); pandemic; pandemic preparedness.