Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.
Peter B GilbertMichal JuraskaAllan C deCampShelly KarunaSrilatha EdupugantiNyaradzo MgodiDeborah J DonnellCarter BentleyNirupama SistaPhilip AndrewAbby IsaacsYunda HuangLily ZhangEdmund CapparelliNidhi KocharJing WangSusan H EshlemanKenneth H MayerCraig A MagaretJohn HuralJames G KublinGlenda GrayDavid C MontefioriMargarita M GomezDavid N BurnsJulie McElrathJulie LedgerwoodBarney S GrahamJohn R MascolaMyron CohenLawrence CoreyPublished in: Statistical communications in infectious diseases (2017)
The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high-level protection, setting a benchmark for future vaccine evaluation and constituting a bridge to other bnAb approaches for HIV-1 prevention.