A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered with and without AS03 Adjuvant in Healthy US Adults

Christina A Rostad; Robert L Atmar; Emmanuel B Walter; Sharon Frey; Jeffery L Meier; Amy C Sherman; Lilin Lai; Rachel Tsong; Carol M Kao; Vanessa Raabe; Hana M El Sahly; Wendy A Keitel; Jennifer A Whitaker; Michael J Smith; Kenneth E Schmader; Geeta K Swamy; Getahun Abate; Patricia Winokur; Wendy Buchanan; Kaitlyn Cross; Ashley Wegel; Yongxian Xu; Inci Yildirim; Satoshi Kamidani; Nadine Rouphael; Paul C Roberts; Mark J Mulligan; Evan J Anderson

doi:10.1093/cid/ciae173

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A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered with and without AS03 Adjuvant in Healthy US Adults

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A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered with and without AS03 Adjuvant in Healthy US Adults

Christina A Rostad, Robert L Atmar, Emmanuel B Walter, Sharon Frey, Jeffery L Meier, Amy C Sherman, Lilin Lai, Rachel Tsong, Carol M Kao, Vanessa Raabe, …

Clinical infectious diseases, Vol.78(6), pp.1757-1768

06/15/2024

DOI: 10.1093/cid/ciae173

PMCID: PMC11175706

PMID: 38537255

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Abstract

A surge of human influenza A(H7N9) cases began in 2016 in China due to an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 adjuvant, prime-boost interval, and priming effects of 2013 and 2017 A(H7N9) IIVs. Healthy adults (n=180), ages 19-50 years, were enrolled into this partially-blinded, randomized, multi-center Phase 2 clinical trial. Participants were randomly assigned to 1 of 6 vaccination groups evaluating homologous versus heterologous prime-boost strategies with two different boost intervals (21 versus 120 days) and two dosages (3.75 or 15 μg of hemagglutinin) administered with or without AS03 adjuvant. Reactogenicity, safety, and immunogenicity measured by hemagglutination inhibition (HAI) and neutralizing antibody titers were assessed. Two doses of A(H7N9) IIV were well tolerated, and no safety issues were identified. Although most participants had injection site and systemic reactogenicity, these symptoms were mostly mild to moderate in severity; injection site reactogenicity was greater in vaccination groups receiving adjuvant. Immune responses were greater after an adjuvanted second dose, and with a longer interval between prime and boost. The highest HAI GMT (95%CI) observed against the 2017 A(H7N9) strain was 133.4 (83.6, 212.6) among participants who received homologous, adjuvanted 3.75 ug+AS03/2017 doses with delayed boost interval. Administering AS03 adjuvant with the second H7N9 IIV dose and extending the boost interval to 4 months resulted in higher peak antibody responses. These observations can broadly inform strategic approaches for pandemic preparedness. (NCT03589807).

2017 H7N9

2013 H7N9

boost

antibody

Avian Influenza

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Title: Subtitle: A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered with and without AS03 Adjuvant in Healthy US Adults
Creators: Christina A Rostad - Emory University
Robert L Atmar - Baylor College of Medicine
Emmanuel B Walter - Duke University
Sharon Frey - Saint Louis University
Jeffery L Meier - University of Iowa
Amy C Sherman - HOPE Clinic
Lilin Lai - HOPE Clinic
Rachel Tsong - Emmes (United States)
Carol M Kao - Emory University
Vanessa Raabe - HOPE Clinic
Hana M El Sahly - Baylor College of Medicine
Wendy A Keitel - Baylor College of Medicine
Jennifer A Whitaker - Baylor College of Medicine
Michael J Smith - Duke University
Kenneth E Schmader - Duke University
Geeta K Swamy - Duke University
Getahun Abate - Saint Louis University
Patricia Winokur - University of Iowa
Wendy Buchanan - National Institute of Allergy and Infectious Diseases
Kaitlyn Cross - Emmes (United States)
Ashley Wegel - Emmes (United States)
Yongxian Xu - HOPE Clinic
Inci Yildirim - Children's Healthcare of Atlanta
Satoshi Kamidani - Emory University
Nadine Rouphael - Emory University
Paul C Roberts - National Institute of Allergy and Infectious Diseases
Mark J Mulligan - Emory University
Evan J Anderson - Emory University
Resource Type: Journal article
Publication Details: Clinical infectious diseases, Vol.78(6), pp.1757-1768
DOI: 10.1093/cid/ciae173
PMID: 38537255
PMCID: PMC11175706
NLM abbreviation: Clin Infect Dis
eISSN: 1537-6591
Grant note: DOI: 10.13039/100000060, name: National Institute of Allergy and Infectious Diseases; DOI: 10.13039/100000002, name: National Institutes of Health, award: HHSN272201300018I, UL1 TR002537; DOI: 10.13039/100006939, name: Emory, award: HHSN272201300015I; DOI: 10.13039/100007856, name: Baylor College of Medicine, award: HHSN272201300020I; name: University of Iowa and National Center for Advancing Translational Sciences; DOI: 10.13039/100008893, name: University of Iowa, award: HHSN27220130021I; DOI: 10.13039/501100008137, name: Saint Louis University, award: HHSN2722013000017I; DOI: 10.13039/100006510, name: Duke University; DOI: 10.13039/100008065, name: Georgia Research Alliance; DOI: 10.13039/100007623, name: Emory University School of Medicine; DOI: 10.13039/100012423, name: Children’s Healthcare of Atlanta; DOI: 10.13039/100016027, name: NYU Grossman School of Medicine; DOI: 10.13039/100000016, name: US Department of Health and Human Services; DOI: 10.13039/100021704, name: Administration for Strategic Preparedness and Response; DOI: 10.13039/100012399, name: BARDA, award: HHSO100201600004I, HHSO100201600006I
Language: English
Electronic publication date: 03/27/2024
Date published: 06/15/2024
Academic Unit: Infectious Diseases; Epidemiology; Medicine Administration; Internal Medicine
Record Identifier: 9984577112602771

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