HIV vaccine trial is halted

  • National Institutes of Health Newsroom
  • NIH
  • 02.02.2020

  • von Liz Scherer
  • Clinical Essentials
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Takeaway

  • 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.

Key points

  • 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.