A Relative Standard for Minimal Risk is Unnecessary and Potentially Harmful to Children: Lessons from the Phambili Trial

Abstract

This commentary discusses the Phambili trial and whether or not it is ethical to enroll 16- and 17-year old adolescents into the ongoing study of an HIV vaccine in South Africa. It provides a background and an ethical analysis on the vaccine trial. It recommends that adolescent subjects should not be included in the Phambili (HVTN 503) study until after the interim efficacy analysis and a decision to permit adolescent enrollment would require a trend in favor of the experimental HIV vaccine at the interim efficacy analysis.