Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial

Kenneth E Schmader; Christine K Liu; Brendan Flannery; Wes Rountree; Heidi Auerbach; Elizabeth D Barnett; Elizabeth P Schlaudecker; Christopher A Todd; Marek Poniewierski; Mary A Staat; Theresa Harrington; Rongxia Li; Karen R Broder; Emmanuel B Walter

doi:10.1186/s12979-023-00355-7

Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial

Immun Ageing. 2023 Jul 1;20(1):30. doi: 10.1186/s12979-023-00355-7.

Authors

Kenneth E Schmader^{1

2}, Christine K Liu^{3

4

5}, Brendan Flannery⁶, Wes Rountree⁷, Heidi Auerbach⁵, Elizabeth D Barnett⁸, Elizabeth P Schlaudecker⁹, Christopher A Todd⁷, Marek Poniewierski⁷, Mary A Staat⁹, Theresa Harrington¹⁰, Rongxia Li¹⁰, Karen R Broder¹⁰, Emmanuel B Walter^{7

11}

Affiliations

¹ Division of Geriatrics, Department of Medicine and Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA. kenneth.schmader@duke.edu.
² Geriatric Research Education and Clinical Center (GRECC), Durham VA Health Care System, Box 3003, Durham, NC, 27710, USA. kenneth.schmader@duke.edu.
³ Section of Geriatrics, Division of Primary Care and Population Health, Stanford University, Stanford, CA, USA.
⁴ Geriatric Research and Education Clinical Center (GRECC), Palo Alto Veterans Affairs Health Care System, Palo Alto, CA, USA.
⁵ Geriatrics Section, Department of Medicine, School of Medicine and Boston Medical Center, Boston University, Chobanian & Avedisian, Boston, MA, USA.
⁶ Infuenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
⁷ Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
⁸ Department of Pediatrics, Section of Pediatric Infectious Diseases, School of Medicine and Boston Medical Center, Boston University, Chobanian & Avedisian, Boston, MD, USA.
⁹ Department of Pediatrics Division of Infectious Diseases, University of Cincinnati College of Medicine and Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
¹⁰ Immunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
¹¹ Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.

Abstract

Background: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.

Results: The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, - 5.8%; 95%CI, - 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.

Conclusions: Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.

Trial registration: ClinicalTrials.gov Identifier: NCT03183908.

Keywords: Adjuvanted influenza vaccine; Aged; High dose influenza vaccine; Immunogenicity; Influenza vaccine.

Associated data

ClinicalTrials.gov/NCT03183908