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; Inci Yildirim; Sharon E Frey; Patricia Winokur; Lisa A Jackson; David I Bernstein; C Buddy Creech; Wilbur H Chen; Richard E Rupp; Jennifer A Whitaker; Varun Phadke; Daniel F Hoft; Dilek Ince; Rebecca C Brady; Kathryn M Edwards; Justin R Ortiz; Megan A Berman; Julia Weiss; Ashley Wegel; DMID 17-0090 Study Group

doi:10.1093/infdis/jiad276

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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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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, Inci Yildirim, Sharon E Frey, Patricia Winokur, Lisa A Jackson, David I Bernstein, C Buddy Creech, Wilbur H Chen, Richard E Rupp, Jennifer A Whitaker, …

The Journal of infectious diseases, Vol.229(2), pp.327-340

02/14/2024

DOI: 10.1093/infdis/jiad276

PMCID: PMC10873179

PMID: 37466221

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Abstract

Influenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown. 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. 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. Serologic responses to a heterologous A(H7N9) MIV boost were highest in participants primed and boosted with adjuvant-containing regimens.

avian influenza

pandemic

influenza A(H7N9)

pandemic preparedness

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Title: Subtitle: Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
Creators: Hana M El Sahly - Baylor College of Medicine
Inci Yildirim - Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
Sharon E Frey - Saint Louis University
Patricia Winokur - University of Iowa, Infectious Diseases
Lisa A Jackson - Kaiser Permanente Washington Health Research Institute
David I Bernstein - University of Cincinnati
C Buddy Creech - Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA
Wilbur H Chen - University of Maryland, Baltimore
Richard E Rupp - The University of Texas Medical Branch at Galveston
Jennifer A Whitaker - Baylor College of Medicine
Varun Phadke - HOPE Clinic
Daniel F Hoft - Saint Louis University
Dilek Ince - University of Iowa, Infectious Diseases
Rebecca C Brady - Cincinnati Children's Hospital Medical Center
Kathryn M Edwards - Vanderbilt University Medical Center
Justin R Ortiz - Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA
Megan A Berman - Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, TX, USA
Julia Weiss - Emmes
Ashley Wegel - Emmes
DMID 17-0090 Study Group
Resource Type: Journal article
Publication Details: The Journal of infectious diseases, Vol.229(2), pp.327-340
Publisher: Oxford University Press (OUP)
DOI: 10.1093/infdis/jiad276
PMID: 37466221
PMCID: PMC10873179
ISSN: 0022-1899
eISSN: 1537-6613
Grant note: DOI: 10.13039/100015691, name: Division of Microbiology and Infectious Diseases; DOI: 10.13039/100000002, name: National Institutes of Health, award: HHSN272201300015I, HHSN272201300018I, HHSN272201300021I, HHSN272201300020I, HHSN272201300019I, HHSN272201300016I, HHSN272201300023I, HHSN272201300022I, 75N93021C00012; DOI: 10.13039/100019822, name: Institute for Clinical and Translational Research, University of Maryland, Baltimore;; DOI: 10.13039/100006108, name: National Center for Advancing Translational Sciences, award: 1UL1TR003098; name: General Clinical Research Center, University of Maryland; DOI: 10.13039/100000016, name: Department of Health and Human Services; DOI: 10.13039/100021704, name: Administration for Strategic Preparedness and Response; DOI: 10.13039/100012399, name: Biomedical Advanced Research and Development Authority, award: HHSO100201600006I, HHSO1002012000131I, HHSO100201600004I; DOI: 10.13039/100014588, name: Sanofi Pasteur; DOI: 10.13039/100004330, name: GSK
Language: English
Electronic publication date: 07/19/2023
Date published: 02/14/2024
Academic Unit: Infectious Diseases; Medicine Administration; Internal Medicine
Record Identifier: 9984473208902771

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