Since the emergence of HIV and AIDS, the world has searched for a vaccine that would prevent the pandemic from spreading. Thirty years later, an HIV Vaccine is still a dream, primarily because the virus has been able to outsmart its human prey.
The long-term goal of the HVTN project is to develop a vaccine that is 100 percent effective and protects everyone from infection.
According to Wakefield, “the Network has successfully opened over 60 studies with more than 20 in active follow up. Those completed have provided a wealth of information on the safety and immunogenicity of a large number of diverse products and regimens. Vaccine candidates that progress into efficacy trials have the greatest potential to advance the field and generate knowledge about what will be needed for protection.” Phase 1 involves a small number of HIV-negative participants who test the safety and various doses of the vaccine. Phase 2 increases the number of participants to the hundreds while Phase 3 involves thousands of HIV-negative participants.
“A variety of studies are in process simultaneously to move with urgency to new knowledge that will ensure the design of a safe and effective vaccine strategy,” Wakefield continues. HVTN itself, “the largest ongoing HIV vaccine clinical study,” is a Phase 2b study that tests a vaccine regimen developed at the National Institute of Allergy and Infectious Diseases (NIAID). This regimen, which Wakefield describes as “a DNA prime followed by a recombinant adenovirus type 5 (Ad5) boost, was found to be the most immunogenic in any HVTN study to date.”
According to the HVTN web site (hopetakesaction.org), the project needs 2,200 volunteers for the vaccine trial. The volunteers must be men who love men or transwomen who love men; 18-50 years old; HIV-negative; and circumcised.
“Circumcision is just one of the criteria for participation,” Wakefield explains. “It was added to ensure safety with this particular product after another trial showed some risk. Persons must be sexually active, willing to participate in counseling sessions and attempt to use the best possible tools available for protection, including condoms. They must also report all drug use (prescription and non-prescription).”
The HVTN vaccine trial involves four shots per participant. These shots could be the research vaccine itself or placebos.
“The original study design was for 1,350 participants. After the results of the iPrEx trial showed evidence that daily PrEP (PreExposure Prohoylaxis) TDF/FTC (Daily tenofovir/emtricitabine) reduced HIV infection risk in gay men and transwomen, the HVTN 505 team examined the data and its protocol and consulted with scientists, advocates and other community leaders,” Wakefield said. “In August 2011, the trial changed its scope to include prevention of HIV infection as a primary endpoint. The trial expanded enrollment from 1,350 to 2,200.”
HVTN 505 trials are being held across the USA, including one in Orlando where, Wakefield attests, “we are fortunate to work with the Orlando Immunology Center under the leadership of Dr. Edwin DeJesus and his talented staff.”
Anyone who would like to learn more about the HVTN 505 study, or to participate in the program, should visit www.hopetakesaction.org.
“HIV negative men and women who are willing to roll up their sleeves are the true heroes in this search,” Wakefield said.
The Orlando Immunity Center is located at 1701 N. Mills Avenue, in Orlando. Its phone number is 407-956-8027.