Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial. Issue 23 (20th May 2022)

• Record Type: Journal Article
• Authors: Ortiz, Justin R.; Spearman, Paul W.; Goepfert, Paul A.; Cross, Kaitlyn; Buddy Creech, C.; Chen, Wilbur H.; Parker, Susan; Overton, Edgar T.; Dickey, Michelle; Logan, Heather L.; Wegel, Ashley; Neuzil, Kathleen M.
• Is Part Of: Vaccine. Volume 40:Issue 23(2022)
• Page Start: 3253
• Page End: 3262
• Publication Date: 2022-05-20
• Subjects: Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2022.03.055
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: Influenza A/H7N9 viruses have pandemic potential. Methods: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety. Results: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt. Conclusions: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule. Clinical Trials Registration: NCT03318315