Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP

Summary

This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.

Timeline

Start

2018-09-12

Primary completion

2020-07-31

Completion

2020-07-31

Publications

• Liu F, Gross FL, Joshi S, Gaglani M, Naleway AL, Murthy K, Groom HC, Wesley MG, Edwards LJ, Grant L, Kim SS, Sambhara S, Gangappa S, Tumpey T, Thompson MG, Fry AM, Flannery B, Dawood FS, Levine MZ. Redirecting antibody responses from egg-adapted epitopes following repeat vaccination with recombinant or cell culture-based versus egg-based influenza vaccines. Nat Commun. 2024 Jan 4;15(1):254. doi: 10.1038/s41467-023-44551-x.
• Gaglani M, Kim SS, Naleway AL, Levine MZ, Edwards L, Murthy K, Dunnigan K, Zunie T, Groom H, Ball S, Jeddy Z, Hunt D, Wesley MG, Sambhara S, Gangappa S, Grant L, Cao W, Gross FL, Mishina M, Fry AM, Thompson MG, Dawood FS, Flannery B. Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1168-e1176. doi: 10.1093/cid/ciac683.
• Dawood FS, Naleway AL, Flannery B, Levine MZ, Murthy K, Sambhara S, Gangappa S, Edwards L, Ball S, Grant L, Belongia E, Bounds K, Cao W, Gross FL, Groom H, Fry AM, Rentz Hunt D, Jeddy Z, Mishina M, Kim SS, Wesley MG, Spencer S, Thompson MG, Gaglani M. Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized Open-Label Trial. Clin Infect Dis. 2021 Dec 6;73(11):1973-1981. doi: 10.1093/cid/ciab566.

Drugs

Indications