RAIVEN

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.

Study phase: IV

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Individuals who are 18-64 years of age, comfortably read and speak English and/or Spanish, work a minimum of 20 hours per week in public-facing/frontline worker jobs or a full-time college student, have access to an internet connection, and plan to remain living in the Tucson area for the next 9 months, are invited to participate in this study. 

Additional information:

Study participants will be asked to do the following activities:

  1. Receive one of two FDA-licensed flu vaccines
  2. Respond to weekly text messages before and during the flu season
  3. Swab your nose if you experience flu-like symptoms
  4. Answer 1 questionnaire at the end of the study
     

Primary disease category: Healthy Volunteers

Secondary disease categories: Healthy Volunteers

This study is enrolling healthy volunteers.

Sponsor: Influenza Division, U.S. Centers for Disease Control and Prevention

Projected enrollment dates: September 2022 to December 2022

Official study title: Randomized Participant- and Investigator-Blinded Trial to Compare the Clinical Efficacy of Recombinant Influenza Vaccine to Standard Dose Egg-Based Inactivated Influenza Vaccine among Adults Aged 18-64 Years in the United States: Centers for Disease Control and Prevention & Westat

External link(s):
http://RAIVENstudy.org/uaz

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT05514002