HVTN 302 is another ExMed trial launched in March that has a direct link to COVID-19. It will test whether the same mRNA technology that was used to provide genetic instructions to make the SARS-CoV-2 spike protein could be used to provide, instead, ingredients to make components of three experimental vaccines. different against HIV/AIDS.
Up to 108 HIV-negative adults will be enrolled in the study. The mRNA ingredients in the vaccines will instruct muscle cells near the injection site to produce proteins that look like the spikes on HIV, but not the virus itself. The hope is that, like the mRNA-induced spikes in COVID-19 vaccines, these HIV spike fragments will stimulate the production of perfectly tuned HIV antibodies to attack the real virus.
“The application of this technology to HIV vaccine research is a watershed moment for the field,” said Fred Hutch virologist Larry Corey, MD, in an HVTN Community Compass article marking the launch of the ‘test.
At the request of Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Corey founded HVTN in 1999 and he remains co-principal investigator of its Fred Hutch-based Leadership and Operations Center.
“We’ve been studying various HIV vaccines for decades, and the science continues to advance, especially with major advances in COVID-19 vaccines involving the use of mRNA technology,” Corey said.
Test combinations of vaccine antigens
Another ExMed trial, HVTN 303, will enroll up to 70 participants in a series of stages evaluating up to three different candidate vaccines alone or in combination. Launched in August, the trial is a collaboration involving multiple HVTN network research centers, including the University of Pittsburgh and Harvard, although no site was established in Seattle.
The first of three vaccines being tested is a so-called fusion peptide conjugate, developed by the NIAID Vaccine Research Center, which used genetic engineering to create pairs of small proteins that normally appear on the surfaces of HIV . Vaccines are designed to stimulate antibodies that block these proteins. The trial will also evaluate an adjuvant – an immune-boosting component that can enhance the effectiveness of the main ingredients. If this first vaccine and its adjuvant show promise, study volunteers could test them in various combinations and dosages with two other vaccines. The antigens in these vaccines are made up of different dummy proteins that mimic the molecular characteristics on the surface of HIV.
“What I like about these studies is that we don’t typically look at vaccine combinations in early phase studies,” said Stephaun Wallace, PhD, MS, Fred Hutch principal investigator and relationship manager. exteriors for HVTN. “Doing this in these studies speaks to the fast pace and step-by-step, or iterative, nature of these trials.”
Elsewhere at Fred Hutch, researchers are exploring ways to improve the delivery of HIV prevention interventions so that people in need can choose a model that best suits their preferences and could also improve their access to care. The field even has a name, “implementation science,” and Fred Hutch researcher Katrina Ortblad, ScD, MPH, is a trained implementation scientist.
Much of his work is focused on finding ways to improve the delivery of HIV pre-exposure prophylaxis, or PrEP, in which people who do not have HIV – but are at risk of getting it – are taking antiviral drug formulations that can protect them against HIV infection.
“When we think about HIV, we have some really good tools available, but a lot of people don’t use them,” Ortblad said. “We have interventions that have been shown to be very effective in clinical trials conducted in controlled environments; so now we’re working to achieve those same effects in real-world settings, breaking down barriers to access and delivery when things aren’t so tightly controlled.
#World #AIDS #Day #overview #continuing #work