The project will survey multiple research groups regarding the minimal immunological profile observed with their candidate in a Phase I trial that would justify advancement of the candidate to an efficacy trial. It is expected that this profile will reflect potential mechanisms of action and/or expected correlates of protection for the candidate vaccine. The Enterprise will summarize outcomes of the survey in a single document/slide set and made available on the web. Such a review would be useful for gap analysis to ensure that the field explores all immune responses that may play a role in protection from HIV. It may also be used by investigators to identify rare or unique aspects of their candidates.
Recently, the Enterprise and its Clinical Trials Collaborators group published a paper describing an “Immune Space Template”, a tool that is used to consistently describe the scope of immune responses elicited by a particular candidate. The tool may serve as a useful starting point to identify immune landscape parameters that can be used to categorize the candidates in the survey. In the future, if deemed useful and appropriate, the two approaches can be combined into a single interactive website.
Project’s objectives and deliverables:
- Gather information on the minimal desired immune responses for at least 15 candidate vaccines at Phase I stage of development or higher.
- As possible, gather this information for vaccine candidates in preclinical studies that are close to advancing to clinical stage.
- Summarize gathered information in a format that makes it easy to review the overall landscape of ongoing efforts: summary document, tables, slides.