Passive Immunization Trials
To Inform Vaccine Design
Many extremely potent and broad HIV neutralizing antibodies (bNAbs) were discovered in the past five years. These discoveries paved the way for passive immunization trials to prevent or treat HIV and/or to achieve sustained remission in HIV-infected individuals.
While the main focus of this work is to prevent or treat HIV infection, clinical studies of these products may also provide valuable insights for HIV vaccine R&D. For example, passive immunization trials could provide information regarding the level of neutralization required for sterilizing protection in serum or mucosal tissues. These and similar data (e.g., how efficacy depends on Ab specificity) may guide development of future HIV vaccine candidates. In August 2014, the Global HIV Vaccine Enterprise convened a meeting to discuss how lessons from passive immunization trials in preventing or treating HIV infection may inform preventive HIV vaccine design.
Objectives and deliverables of the meeting
- The following questions/topics will be discussed during the meeting:
- What data are required to inform vaccine design? Can this information be obtained from early-stage clinical studies, or is an efficacy study required?
- Designs of ongoing and future clinical trials and how they can inform vaccine research.
- What data will be used to select bNAbs or combinations to test in clinical studies to inform vaccine design?
- Will candidates be tested in clinical studies to inform vaccine design if they are not on the product development pathway?
- Will data obtained by multiple groups be comparable, complementary, and able to address questions that could not be answered in a single study?
- Which core set of standardized assays will be performed on specific tissues?
- Which endpoints will be evaluated to inform vaccine design?
- Are there any questions or opportunities that have been overlooked by any group(s)?
Date and Location
8 August 2014, Downtown Marriott, New York City, USA
- Pervin Anklesaria, The Bill & Melinda Gates Foundation
- Barney Graham, Vaccine Research Center, NIAID
- Michel Nussenzweig, Rockefeller University
- Yegor Voronin, Global HIV Vaccine Enterprise