RAIVEN Study Will Examine Efficacy of Flu Vaccines

University of Arizona Health Sciences researchers will conduct a phase 4 clinical trial to assess how well two different influenza vaccines protect people from the flu as part of the Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN), a research collaboration between the Centers for Disease Control and Prevention, Westat and multiple sites in the United States.

The study will evaluate the efficacy of two vaccines: the recombinant influenza vaccine and the standard-dose egg-based inactivated influenza vaccine (SD IIV). The recombinant influenza vaccine (RIV) is a Food and Drug Administration-approved alternative option to SD IIV, which has been used in adults for almost a century.

“We are excited to conduct a real-world test of the RIV vaccine and see how effective it is in protecting college students and frontline workers from influenza,” said Karen Lutrick, PhD, assistant professor in the UArizona College of Medicine – Tucson’s Department of Family and Community Medicine. “An important goal of the RAIVEN study is to increase the accessibility of this type of research. We are proud to represent Arizona in this national network.”

Dr. Lutrick and Ashley Lowe, PhD, MSPH, postdoctoral fellow in the UArizona Health Sciences Asthma and Airway Disease Research Center, are leading the Arizona study site, which is one of six in the United States. Westat is managing the $1 million subcontract with funding provided by the Centers for Disease Control and Prevention.

People between the ages of 18 and 64 who live in Tucson are eligible to participate in the study, though researchers are specifically seeking to enroll college students and frontline workers. Both populations have frequent face-to-face community contact, placing them at higher risk for contracting the flu.

Participants will be randomly assigned to receive either the SD IIV vaccine or the RIV vaccine. Throughout the winter and spring, they will answer surveys about potential illness and take self-administered influenza tests to evaluate how well the vaccines prevented illness.

“If RIV demonstrates improved clinical efficacy as compared with SD IIV, health officials can provide updated vaccine recommendations to clinicians, county and state health departments, and the general public,” Dr. Lowe said.

“Drs. Lutrick and Lowe are respected researchers and have the experience and expertise to lead this important CDC study in Arizona,” said Kristen Rundell, MD, professor and chair of the Department of Family and Community Medicine. “Our department values research that has a direct impact on the patients and the community we serve.”

To learn more or enroll in the RAIVEN study, visit: https://raivenstudy.org/uaz

The study, “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,” a.k.a. “The RAIVEN Study,” is funded by the Centers for Disease Control and Prevention under award #75D30121C12393.