Book 5: Control group

As long as there is no known effective HIV preventive vaccine, a placebo control arm should be considered ethically acceptable in an HIV preventive vaccine trial.

11.1 A vaccine with proven efficacy in preventing infection or disease from HIV does not currently exist. Therefore, the use of a placebo control arm is ethically acceptable in appropriately designed protocols.

11.2 Participants in the control arm of future HIV preventive vaccine trials should receive an HIV vaccine known to be safe and effective when such is available, unless there are compelling scientific reasons which justify the use of a placebo.

11.2.1 Compelling scientific reasons to use a placebo rather than a known effective HIV vaccine in the research population include:

1. Evidence that the HIV vaccine is highly unlikely to be effective against the virus that is prevalent in the research population; and
2. Convincing reasons to believe that the biological conditions that prevailed during the initial trial demonstrating efficacy were so different from the conditions in the proposed research population, that the results of the initial trial cannot be directly applied to the research population under consideration.

11.3 All participants should receive the benefit of active promotion of HIV preventive interventions (see Points 10 and 14).

11.3 Based on scientific requirements, the balance of risks and benefits to active versus control arms, and the wishes of participants, due consideration could be given to the use in the control arm of a vaccine to prevent a relevant condition other than HIV.