NMCSD Participates in Operation Warp Speed COVID-19 Vaccine Trial

Photo By Petty Officer 2nd Class Jacob L. Greenberg | 201217-N-DA693-1062 SAN DIEGO (Dec. 17, 2020) Davina Fanning, a registered nurse and clinical research coordinator assigned to Naval Medical Center San Diego’s (NMCSD) Naval Branch Health Clinic (NBHC) Kearny Mesa, administers a shot to a patient for the Phase III trial of AstraZeneca’s coronavirus (COVID-19) vaccine candidate Dec. 17. The injection is either the vaccine candidate or a placebo. The trial is part of Operation Warp Speed, a national initiative to accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics. NMCSD’s mission is to prepare service members to deploy in support of operational forces, deliver high quality healthcare services and shape the future of military medicine through education, training and research. NMCSD employs more than 6,000 active duty military personnel, civilians, and contractors in Southern California to provide patients with world-class care anytime, anywhere. (U.S. Navy photo by Mass Communication Specialist 3rd Class Jake Greenberg)  

SAN DIEGO, CA, UNITED STATES

12.10.2020

Story by Petty Officer 3rd Class Jacob L. Greenberg 

Naval Medical Center San Diego

SAN DIEGO – Naval Medical Center San Diego (NMCSD) is one of five Department of Defense (DOD) locations taking part in the Phase III trial to evaluate the COVID-19 trial vaccine under development by AstraZeneca.
The other sites include Brooke Army Medical Center in San Antonio, Wilford Hall Ambulatory Surgical Center in San Antonio, Walter Reed National Military Medical Center in Bethesda, Maryland, and Fort Belvoir Community Hospital in Virginia.
The trial is part of Operation Warp Speed, a national initiative to accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics.
“Planning for the trial began in the summer, and enrollment began in early November,” said Capt. Ryan Maves, NMCSD’s site principle investigator for the vaccine trial. “The trial at NMCSD is open to any adult Military Health System (MHS) beneficiary, such as active duty service members, retirees and dependents. The study is to evaluate a vaccine to prevent COVID-19. Our volunteers should not have an active infection at the time of enrollment.
In general, there are relatively few exclusion criteria.
“We are specifically looking to recruit participants who are at an increased risk of COVID-19 infection due to their occupation, racial or ethnic background, or any chronic medical conditions, such as cardiac, respiratory or kidney disease,” said Maves, who works in NMCSD’s Infectious Diseases Division and is an associate professor of medicine at the Uniformed Services University of the Health Sciences.
The AstraZeneca vaccine trial is one of many national trials being conducted through Operation Warp Speed, and the first vaccine trial to include the DOD. With more than 80 sites in communities nationwide, the trial has an overall target enrollment of 30,000 participants. Military sites are looking to draw 3,000 of those volunteers, according to a DOD release.
The AstraZeneca vaccine trial began in November after a voluntary pause in October to investigate a single event of an unexplained illness in one of the UK participants. After a review of an independent committee’s recommendations, health authorities across the world, including the U.S. Food and Drug Administration, concluded the trials were safe to resume.
“This study is a randomized, double-blinded, placebo-controlled trial of the ChAdOx1 vaccine, developed at the University of Oxford and manufactured by AstraZeneca,” said Maves. “In this study, two-thirds of volunteers will receive the active vaccine candidate, which comes in a two-dose series. One third of participants will receive a placebo injection. We will then monitor them for up to two years, both with blood tests to monitor their immune responses and clinically for any evidence of infection with SARS-CoV-2, the virus that causes COVID-19.”
DOD sites, including NMCSD, are open on a voluntary basis to MHS beneficiaries.
“We are not enrolling pregnant women or children at this time, and potential participants with weakened immune systems due to cancer treatment, immunosuppressant medication use, or other significant conditions that affect the immune system are also not able to be recruited right now,” said Maves. “However, people living with well-controlled HIV infections on antiretroviral therapy are eligible.”
According to a DOD release, the study is looking for people who are at an increased risk of COVID-19. Those who work in high-risk jobs, such as healthcare professionals, emergency response personnel, grocery workers, meat-packing plant workers, restaurant staff and public transit staff are especially encouraged to participate. People who live in densely-populated residential environments, or live or work in congregated living facilities, such as nursing homes, are also encouraged. Members of some of the most COVID-19-impacted communities, such as the elderly, individuals with underlying health conditions, and racial or ethnic groups such as African-Americans, Latinos and Native American populations are among the target demographics for the trial vaccine candidate. Participants will receive two doses of the vaccine candidate or placebo, approximately one month apart.
Along with scheduled visits, participants will be asked to come in if they have symptoms throughout the year to be tested for COVID-19. Study participants will be followed-up with for two years to determine the vaccine’s efficacy, while being compensated for their participation.
“The goal of the trial is to determine whether the ChAdOx1 vaccine is safely able to protect people from COVID-19, both in terms of total infections, as well as protecting those who get infected from severe disease,” said Maves.
NMCSD’s mission is to prepare service members to deploy in support of operational forces, deliver high quality healthcare services and shape the future of military medicine through education, training and research. NMCSD employs more than 6,000 active duty military personnel, civilians and contractors in Southern California to provide patients with world-class care anytime, anywhere.
Visit navy.mil or facebook.com/NMCSD for more information.

• Date Taken: 12.10.2020
• Date Posted: 12.17.2020 17:47
• Story ID: 385108
• Location: SAN DIEGO, CA, US