A trial for a new AIDS vaccine is set to begin soon. While there have been over 100 AIDS vaccines developed over the years, Dr. Robert Gallo, who in 1984 co-discovered that HIV triggered AIDS, has worked on this one for the last 15. It is a bit different than other vaccines available, and researchers hope it will change the future of HIV/AIDS research.
Dr. Gallo has been an important figure in the crusade against HIV/AIDS for decades. In addition to discovering the link between HIV and AIDS, he helped to develop the HIV blood test, which allowed screening for AIDS. He holds 32 honorary doctorates, is the author of over 1,200 scientific publications, and was the most referenced scientist in the world in the 1980s and 1990s.
The vaccine trial has been largely funded by the Bill & Melinda Gates Foundation and is being launched by Gallo and his team at the Institute of Human Virology (IHV) in Baltimore, Maryland, in partnership with Profectus BioSciences, a biotech company derived from IHV. IHV was co-founded by Dr. Gallo in 1996 and was the first of its kind. They combine the disciplines of research, patient care, and prevention programs to hasten the speed of medical breakthroughs. IHV has cared for and treated more than one million HIV-positive individuals in seven African nations, two Caribbean nations, and over 6,000 HIV-positive individuals in Baltimore.
The phase I study plans to enroll 60 people, 20 of which will initially receive the vaccine. This stage will assess the safety of the vaccine and the immune responses. The steps to FDA approval are as follows:
Phase I: Tests the safety of a vaccine candidate in up to 100 volunteers for up to two years.
Phase II: Continues testing the safety of a drug candidate and whether it provokes an immune response in several hundred volunteers at risk of acquiring HIV.
Phase IIb: Tests the vaccine’s effectiveness in a larger population of several thousand at-risk individuals. (The combined Phase II trials may last longer than two years.)
Phase III: Tests the vaccine’s effectiveness in at least 10,000 at-risk individuals and monitors for adverse reactions for up to four years.
The science behind the vaccine is a bit complicated for the layperson, but essentially, HIV works by attaching itself to two T-cell receptors, which infect the immune cells, turning a person’s immune system against them. The goal of this vaccine is to stop HIV from attaching itself to the second T-cell receptor.
According to Gallo, “The results in monkeys are interesting, but they’re not perfect. If we keep just using monkeys, we’re never going anywhere. We need for humans to respond.”
Gallo, who is now 78, says that it has taken such a long time to develop this vaccine because of difficulties in securing funding, time-intensive and extensive testing that has been done on monkeys, and the significant challenge of developing the vaccine into a human-grade product.
Researchers are optimistic, and hope this represents a significant breakthrough in HIV/AIDS research, which affects approximately 35 million people worldwide.