Q&A: Millions of volunteers needed for COVID-19 vaccine trials

The NIH recently announced the launch of a collaborative effort to test vaccine candidates for COVID-19 in the United States.

The collaboration, known as the COVID-19 Prevention Network (CoVPN), merges four existing clinical trial networks funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID): the HIV Vaccine Trials Network (HVTN), based in Seattle; the HIV Prevention Trials Network, based in Durham, N.C.; the Infectious Diseases Clinical Research Consortium, based in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles.

“Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against COVID-19,” NIAID Director Anthony S. Fauci, MD, said in a press release.

Fred Hutchinson Cancer Research Center is the coordinating center for CoVPN’s vaccine trials. Several vaccine candidates will be tested, including the investigational mRNA-1273 vaccine.

Millions of volunteers are needed for phase 3 trials to meet the appropriate demographics, according to Jim Kublin, MD, MPH, executive director of CoVPN’s operations program. As of July 24, about 180,000 people have signed up on the registry, he said.

Healio Primary Care spoke with Kublin, who is also principal staff scientist in the vaccine and infectious disease division at Fred Hutchinson and clinical professor of global health at the University of Washington, to learn more about CoVPN and how primary care physicians can help patients who are interested in becoming volunteers sign up for the clinical trials registry.

Q: How did this project get started? What are the biggest challenges you are facing?

A: CoVPN was formed by the NIAID to respond to the global pandemic. The Network is leveraging the infectious disease expertise of its existing research networks and global partners to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. We are coordinating COVID-19 vaccine trials that are inclusive of all communities, and with a focus on communities who are at higher risk for COVID-19. Our biggest challenge, which is to enroll an estimated 30,000 volunteers for each phase 3 trial, is also an opportunity to encourage communities from diverse racial/ethnic, geographic and age groups to enroll. Their enrollment will help find a safe vaccine that is generalizable to many populations.

Q: What criteria do patients need to meet in order to be a volunteer?

A: Deciding to join the COVID-19 vaccine trials is completely voluntary.

• We encourage people interested in volunteering for the trials to register online, and a local trial site will be in touch as more information becomes available.
• A physical exam will be done to do health screens to check a volunteer’s weight, temperature, BP, etc. to help determine their eligibility to enroll.
• We need everyone who is willing to volunteer enter their information in the Volunteer Screening Registry. We have no cap on the number of volunteers.

Q: What can primary care physicians in the U.S. do to help?

A: Clinical trials for any investigational drug have a rigorous informed consent process that describes the risks and the benefits of participating. Physicians can help volunteers understand the importance of the informed consent process and encourage volunteers to make informed decisions when their questions are answered.

Physicians can familiarize themselves with the CoVPN website FAQs. If any of their patients or their patient family members are interested in volunteering, direct them to the website.

Q: When do you predict the first clinical trial results will be released?

A: It’s too soon to say when the first clinical trial results will be released. Our most immediate objective is to coordinate inclusive and scientifically rigorous studies that communities trust to be safe.

*Photo credit for Kublin’s headshot: Fred Hutchinson Cancer Research Center