Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years

Summary

This randomized, active comparator trial will compare the clinical efficacy of recombinant influenza vaccine (RIV) to standard-dose egg-based inactivated influenza vaccine (SD IIV) among adults aged 18-64 years. The primary study hypothesis is that the clinical efficacy of RIV is superior to that of SD IIV to prevent and attenuate influenza-like illness (ILI)-associated influenza virus infection. Relative efficacy will be assessed by comparing rates of ILI-associated reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza virus infection and measures of infection and illness attenuation among participants who receive RIV versus SD IIV. A secondary hypothesis is that humoral and cell-mediated immune responses to RIV are superior to responses to SD IIV. Relative immunogenicity will be assessed by comparing markers of humoral and cell-mediated immune responses post-vaccination among a subset of participants who receive RIV versus SD IIV.

Timeline

Start

2022-09-13

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Grant L, Whitaker JA, Yoon SK, Lutrick K, Bhargava S, Brown CP, Zaragoza E, Fink RV, Meece J, Wielgosz K, El Sahly H, Hegmann KT, Lowe AA, Southworth A, Tatum T, Ball SW, Levine MZ, Thiese MS, Battan-Wraith S, Barnes J, Phillips AL, Fry AM, Dawood FS; Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN). Relative Effectiveness and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Versus Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years: Results and Experience From a Randomized, Double-Blind Trial. Open Forum Infect Dis. 2024 Sep 26;11(10):ofae559. doi: 10.1093/ofid/ofae559. eCollection 2024 Oct.

Drugs

Indications