Clinical Trials Unit lands major grant renewalFeb. 11, 2021, 9:41 AM
by Bill Snyder
Vanderbilt University Medical Center and Washington University School of Medicine in St. Louis have received renewal of a major federal grant to continue their collaboration to test and develop new treatments and vaccines against HIV/AIDS — and now COVID-19.
The grant from the National Institute of Allergy and Infectious Diseases of the National Institute of Health will provide an estimated $17.5 million over the next seven years to the AIDS Clinical Trials Units (CTUs) at both institutions.
Vanderbilt’s CTU consists of the Vanderbilt Therapeutics Clinical Research Site (VTCRS), part of the national AIDS Clinical Trials Group, and also the Vanderbilt Vaccine Clinical Research Site (VVCRS), part of the national HIV Vaccine Trials Network. In addition to continuing the work on AIDS, both entities have joined the fight against COVID-19.
“Vanderbilt has been at the forefront of HIV vaccine research and clinical trials since the beginning of the epidemic,” said VVCRS principal investigator Spyros Kalams, MD, associate professor of Medicine at VUMC. “Our research team is extremely proud to continue these efforts to develop an effective HIV vaccine.”
“I am exceptionally proud of our Vanderbilt ACTG research team, and grateful to our study volunteers for making this award possible,” added VTCRS principal investigator David Haas, MD, professor of Medicine. “Our entire research team is thrilled and honored to be able to continue our noble mission to help end the AIDS pandemic.”
Rachel Presti, MD, PhD, medical director of Washington University’s Infectious Diseases Clinical Trials Unit, is co-principal investigator with Haas and Kalams of the renewed grant. All three are now heavily involved in clinical COVID-19 studies.
Kalams and Presti are leading efforts at their institutions to test the safety and effectiveness of investigational vaccines against SARS-CoV-2, the virus that causes COVID-19.
“The infrastructure of the HIV Vaccine Trials Network has taken years to develop and has played a vital role in the rapid testing of SARS-CoV-2 vaccines,” Kalams said. “We look forward to our new expanded mission to end the SARS-CoV-2 epidemic.”
In December the U.S. Food and Drug Administration granted emergency use authorization to Moderna’s COVID-19 vaccine, which was tested at VUMC, following approval of the Pfizer vaccine.
Haas and Presti are co-principal investigators of the ACTIV-2 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) protocol, which is evaluating the safety and efficacy of new potential therapeutics to limit COVID-19 illness in patients with mild to moderate symptoms.
One of the treatments, bamlanivimab, an investigational monoclonal antibody given by intravenous infusion, was approved for emergency use in November and is now being offered through the COVID Infusion Clinic at VUMC.
“When people are infected with COVID-19, they may feel pretty well at first, but they can become very sick very fast, no matter their age,” Haas said in announcing the ACTIV-2 study at VUMC last fall. “Our hope is that the treatment keeps people alive and out of the hospital.”