- National Institute of Allergy and Infectious Diseases (NIAID) announced that it has halted the Uhambo (HVTN 702) clinical trial because of ineffectiveness of the trial HIV vaccine.
Why this matters
- NIAID emphasized that there was no concern over HVTN 702 vaccine safety, which was closely monitored throughout the trial by an independent data and safety monitoring board (DSMB).
- Participant monitoring continues.
- Additional vaccine regimens (novel mosaic vaccine regimen, effectiveness of broadly neutralizing antibodies) are involved in late-stage investigational trials.
- Starting in 2016, HVTN enrolled and randomized 5407 sexually active South African HIV-negative adults (ages, 18-35 years) across 14 sites to investigational vaccine or placebo injections (6 injections over 18 months) plus preventative HIV standard of care (including oral preexposure prophylaxis).
- HVTN 702 vaccine regimen was modified to be specific for HIV subtype Clade C:
- Canarypox vector-based vaccine (ALVAC-HIV).
- 2-component, adjuvanted gp120 protein subunit vaccine.
- Booster shots were administered at 1 year, 19 months to prolong previously observed protective effect.
- A January 23 DSMB interim analysis of 2694 vaccine recipients vs 2689 placebo recipients demonstrated no significant efficacy based on the primary objective (number of participants diagnosed with HIV after >60% had been in study for >18 months):
- 129 HIV infections occurred among vaccine recipients compared with 123 among those receiving placebo.