Military Health System participating in COVID-19 vaccine trial
Military Health System participating in COVID-19 vaccine trial
Five military medical treatment facilities in the National Capital Region, Texas, and California are participating in a phase 3 clinical trial testing the AstraZeneca COVID-19 vaccine in development under Operation Warp Speed. The DoD sites are actively enrolling study participants, with a goal to recruit up to 1,000 volunteers in each of the three market areas towards the total AstraZeneca clinical trial enrollment of 30,000 people.
Operation Warp Speed, a multiagency U.S. Government effort led by the Department of Health and Human Services and the Department of Defense, is working with the private sector with the aims to deliver safe and effective COVID-19 vaccine doses to the American public beginning January 2021.
OWS is funding clinical trials evaluating several vaccine candidates which were selected based on promising data on safety, immune response, and protection in animal studies and safety and immune response data in early-stage trials in humans. Each of the trials is designed to collect data on how well a vaccine candidate protects against COVID-19 and on the safety of the vaccine candidate in a larger population, including people most at risk.
“The Department of Defense continues to play a key role in the development of a potential COVID-19 vaccine,” said Thomas McCaffery, assistant secretary of Defense for Health Affairs. “Now that vaccines have passed the first phases of testing for safety, dosing, and response, we have moved into the next phase where volunteers are needed to join large clinical studies. We are excited to have several sites supporting these next steps in the vaccine development process.”
Large phase 3 clinical trials are a necessary part of the rigorous scientific process to test the efficacy and safety of a vaccine in a real-world setting with a large population sample, said Air Force Col (Dr.) Jessica Cowden, chief medical officer of the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnology Vaccine Acceleration Project.
“Phase 3 studies are designed to evaluate if the vaccine can prevent disease in the populations of people that the vaccine is being developed to protect,” said Cowden. “Phase 3 studies are large and usually involve some people who are at risk for infection and disease.”
The National Institute of Allergy and Infectious Diseases at the National Institutes of Health established a network of infectious disease experts and research partners, termed the Coronavirus Prevention Network, or CoVPN, to rapidly and thoroughly evaluate U.S. government-sponsored COVID-19 vaccines. The CoVPN website (https://www.coronaviruspreventionnetwork.org/) provides general information about products being developed to prevent COVID-19 and about clinical trials.
According to the CoVPN, interested volunteers must be adults aged 18 and older to be screened for these initial trials. The CoVPN recognizes the importance of including volunteers who are more likely to get COVID-19, such as those over the age of 65 or with underlying medical conditions; as well as people who work in an essential job, live in a densely populated area, or represent a racial and ethnic group greatly impacted by the epidemic.
Representation by such groups matters in Phase 3 trials because vaccines need to be tested in populations who are at most risk of being exposed to the disease and getting sick in the real world, explained Cowden. “At-risk populations shouldn’t bear a disproportionate burden of research, but they need to be represented,” she said
The selected DoD sites are currently enrolling volunteers for the AstraZeneca clinical trial, according to Cowden. The trial is a randomized control, double-blind study, meaning volunteers will either receive the study vaccine or saline. “The study team and the participant will be blinded so that they won’t know which the participant received until the end of the study,” Cowden said. AstraZeneca’s vaccine candidate is in late-stage clinical trials ongoing in the U.K., Brazil and South Africa.
“Participating in a vaccine clinical trial is voluntary but is also critically vital to ensure that the overall effort is ultimately successful,” said Dr. Sean Biggerstaff, acting deputy director, DHA Research and Development Directorate. “Volunteers should also know safety remains an overriding priority for anyone participating in clinical trials.”
Military health beneficiaries who wish to volunteer for the AstraZeneca COVID-19 vaccine at a nearby military medical treatment facility (or at a civilian site close to home) can contact the local study team directly to request more information or can register on the CoVPN website and consent to be contacted by a research team. If registering on the CoVPN site, interested volunteers should enter the appropriate code in parenthesis from the list below, or enter their ZIP code to join the registry. Site contact information is included here:
- Naval Medical Center San Diego, California – 253-341-5328 or 253-341-6007; firstname.lastname@example.org; (CoVPN Site Code: NMSD)
- Brooke Army Medical Center – 253-924-9458; email@example.com; (CoVPN Site Code: BAMC)
- Wilford Hall Ambulatory Surgical Center – 253-341-6170; firstname.lastname@example.org; (CoVPN Site Code: WHMC)
- Walter Reed National Military Medical Center – 253-341-6542; email@example.com; (CoVPN Site Code: WRMC)
- Fort Belvoir Community Hospital – 253-341-5163; firstname.lastname@example.org; (CoVPN Site Code: FBCH)
At this point, the DoD is only participating in the AstraZeneca study. Additional DoD sites are being prepared for participation in other clinical trials of vaccines and monoclonal antibodies to prevent COVID-19, said Cowden.
“Having a safe and effective COVID-19 vaccine is what we need to protect people and get life back to normal, but in order to get to that point, we have to do these clinical trials,” explained Cowden. “These big Phase 3 clinical trials with a lot of people participating are critical so we can get the information we need to determine if a vaccine candidate is safe and can prevent COVID-19.”
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