GeoVax Labs, a biotechnology company developing human vaccines for Ebola and HIV, today announced that the HIV Vaccine Trials Network (HVTN) has assigned a trial number, HVTN 114, to the next clinical trial of its clade B preventive HIV vaccine candidate.
HVTN 114, titled: "A Phase 1 clinical trial to evaluate the immunogenicity of AIDSVAX® B/E bivalent gp120 vaccine and MVA/HIV62B in healthy, HIV-1 uninfected adult participants who previously received MVA/HIV62B in DNA/MVA or MVA/MVA regimens in HVTN 205," is expected to begin enrolling patients during the second half of 2015.
HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GeoVax vaccine (concluded in 2012) and will test the ability of late boosts to increase the antibody responses elicited by the GeoVax vaccine. The late boosts will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, will be supplied by Global Solutions for Infectious Diseases (GSID) and is the same protein used to boost immune responses in the partially successful RV144 vaccine trial in Thailand. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone. HVTN 205 included two different vaccine regimens; HVTN 114 will allow for five separate study groups (up to 20 in each group), and participants will be assigned to each group depending upon their initial vaccine regimen from HVTN 205.
The primary objectives of the trial are (a) to determine the safety of MVA62B and AIDSVAX B/E given separately or together as boost injections after prolonged immunologic rest, to participants who received vaccinations in HVTN 205, and (b) to compare HIV-specific antibody responses to MVA62B and AIDSVAX B/E given separately or together. Secondary objectives are to further characterize HIV-specific antibody and T cell responses to MVA62B and AIDSVAX B/E given separately or together, and to compare durability of the responses at 6 months after the boosts.
Harriet L. Robinson, Ph.D., GeoVax's Chief Scientific Officer, commented, "Protein boosts were important for the one partially successful HIV vaccine trial, RV144, and we will be testing the effect of the same boost used in RV144 on our vaccine. We believe the HVTN and its funding agency, the National Institute of Allergy and Infectious Disease (NIAID), are taking the prudent step to evaluate the impact of protein boosts in combination with GeoVax vaccines. Information from this trial will inform the design of future, larger, clinical trials. We are pleased that HVTN approved the concept protocol for HVTN 114 and we look forward to taking the steps necessary for initiation of the trial and commencement of patient enrollment."