While the Military Health System continues to support the development and distribution of COVID-19 vaccines to counter the ongoing public health threat of the disease, it’s investing in other efforts to counter the SARS-CoV-2 virus.
One of those includes evolving therapeutics as part of the U.S. government’s COVID-19 response through clinical trials of a long-acting antibody combination medicine to prevent COVID-19 among people who have been exposed to the disease.
The intramuscular long-acting antibody product, called AZD7442 and developed by AstraZeneca, is undergoing a phase III clinical trial at five Department of Defense sites to study its efficacy among eligible MHS beneficiaries who have recently been exposed to others with SARS-CoV-2 infection.
“This study will run for one year, although interim and primary analyses will likely occur much earlier in 2021,” said Dr. Simon Pollett, associate scientific director and COVID-19 research area director at the Uniformed Services University of the Health Science’s (USU) Infectious Diseases Clinical Research Program (IDCRP).
Under the name STORM CHASER, Pollett’s program is coordinating teams of physicians, nurses, pharmacists, and clinical research staff at Tripler Army Medical Center in Hawaii, Madigan Army Medical Center in Washington, William Beaumont Army Medical Center in Texas, Naval Medical Center Portsmouth in Virginia, and USU in Maryland. The lead investigators at these sites are Army Col. Viseth Ngauy, Army Col. Anjali Kunz, Dr. Gina Kubicz, Navy Lt. Cmdr. Tida Lee, and Army Lt. Col. Jeffrey Livezey, respectively.
This study is designed to prevent the development of illness in people who have been exposed to COVID-19 in care homes and sites with enhanced risk of disease transmission, under the sponsorship of AstraZeneca with support from the U.S. health information technology and clinical research firm IQVIA. IDCRP is supported through a cooperative agreement with The Henry M. Jackson Foundation for the Advancement of Military Medicine.
Primarily, STORM CHASER seeks to determine if the antibody injection can prevent COVID-19 in people who were exposed to the SARS-CoV-2 virus – which causes the disease – within the last eight days, but have not yet developed symptoms, explained Pollett. “This may include those exposed by household contacts, in crowded working conditions, in health care settings, and other scenarios,” he added.
A secondary objective of the study is examining whether the antibody injection can reduce viral shedding in those who may develop the disease after receiving the injection, said Pollett. Viral shedding occurs when the virus replicates inside the body and is released to the environment, making the host person contagious to others.
“Reduced viral shedding may perhaps correlate with reduced transmissibility, but this requires further study,” said Pollett.
STORM CHASER also aims to see if individuals who receive the AZD7442 injection after SARS-CoV-2 exposure experience less severe symptoms of COVID-19. Likewise, the clinical trial seeks to explore “sequencing of breakthrough virus to look at antibody escape mutations,” said Navy Capt. Timothy Burgess, IDRCP director. This will help determine whether AZD7442 protects across a range of SARS-CoV-2 strains, including newly emerged variants.
AZD7442 contains infection-fighting proteins called monoclonal antibodies that work to neutralize the virus, thus preventing COVID-19. Each dose is given once as two intramuscular shots in each gluteal region, within eight days of exposure.
If clinical trials are successful and the product receives emergency use authorization from the Food and Drug Administration, this investigational product would become another tool to defeat the COVID-19 pandemic. Two vaccines, by Pfizer-BioNTech and Moderna, are available to the U.S. population older than 16 and 18 years of age, respectively, under FDA’s EUA, with three more vaccines, including AstraZeneca’s, currently in clinical trials.
The vaccines work inside the body by triggering the immune system to make antibodies that will block or kill the SARS-CoV-2 spike protein if it enters the body, which results in immunity to coronavirus. They are given to healthy individuals who have not been exposed to the virus to protect them against getting seriously ill from the disease if they become infected or exposed, and studies are still being conducted to gauge their ability to keep people from spreading the virus.
AZD7442 may provide very rapid protection against COVID-19 in individuals who have been exposed because it is given while the virus is incubating, said Burgess. But those who have already received the COVID-19 vaccine are not eligible to participate in the study.
“The investigational product is intended to provide rapid immunity after exposure, with up to six months of protection thereafter,” said Burgess. “STORM CHASER is examining the efficacy of this.”
If the study is successful in achieving its objective of preventing COVID-19 after exposure, the hope, according to Pollett, is that transmission chains will also be stopped by preventing such COVID-19 cases, but further study is required.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense; under Contract No. W911QY-21-9-0001.
If interested in participating in the STORM CHASER trial - please contact Julia Rozman at: julia.rozman.ctr@usuhs.edu.