How is the safety of the investigational vaccine monitored?
Several groups monitor this trial for safety and to make certain the study is being conducted according to scientific and ethical standards. These groups include the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), the HIV Vaccine Trials Network and local Institutional Review Boards (also called Ethics Committees). Physicians on the team that design the studies will monitor the safety of the trials. This team carefully considered all of the available information to decide that the investigational vaccine was safe enough to study in this trial. In addition, there will be an independent Data and Safety Monitoring Board (DSMB). A DSMB is a group of experts that are not part of the HVTN, or the researchers, who will carefully monitor the safety of the trial participants. If there are safety concerns, the DSMB can recommend that the trial be changed or stopped.
