South African HIV Vaccine Clinical Trial Plagued with Protocol Deviations: What Are Lessons Learned

Results from a clinical trial (NCT02968849) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) included collaborators Sanofi, GlaxoSmithKline and the Bill and Melinda Gates Foundation. Conducted in South Africa at multiple trial site locations, this study was led by Dr. Glenda Gray, Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital (the world’s third biggest facility) located in Johannesburg. The Phase 2/3 clinical trial was designed to evaluate the preventive vaccine efficacy, safety and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over a 24-month period, and potentially up to 36 months from enrollment. The study was plagued with costly protocol deviations, leading to a series of study findings and recommendations for improved quality of clinical research. TrialSite introduces the concept of holistic, trial site level accreditation as a means to differentiate quality sites. “Vocational certainty,” a concept promulgated by quality guru Dr. Larry Kennedy, becomes an imperative prerequisite for success in research.

Targeting 5,404 participants, this study investigated the vaccine efficacy, safety, and tolerability of the ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative South African adults over 24 months from enrollment.