Barouch: Replicating Adenovirus Vectors
The consortia led by Dr. Dan Barouch at the Beth Israel Deaconess Medical Center will address the hypothesis that replicating adenovirus (Ad) vectors can induce potent HIV-specific mucosal immune responses as well as fundamentally different qualities of immune responses when compared with non-replicating Ad vectors. The impact of vector replication on the magnitude, durability, and quality of vaccine-elicited HIV-specific immune responses as compared to non-replicating Ad vectors will be evaluated in Phase 1 studies in healthy volunteers. The replicating Ad vectors will include the “mosaic” HIV-1 Env antigen, which is an
in silico recombined antigen sequence aimed at optimizing immunologic coverage of global virus diversity.
The work done by the consortia will develop an HIV vaccine using a replicating adenovirus serotype 26 (Ad26) vector expressing the HIV mosaic Env antigen. Ad26 is less prevalent in human populations than Ad5 and biologically substantially different with important advantages over Ad5.
This consortium is led by Dr. Barouch and includes researchers from Beth Israel Deaconess Medical Center (BIDMC), Brigham and Women’s Hospital, University of Rochester, Batavia Bioservices, PaxVax, and IAVI.
- 1. Perform preclinical evaluation of replicating simian Ad vectors to determine their immunogenicity and efficacy in the non-human primate (NHP) challenge model.
- 2. Complete GMP manufacturing and release of the replicating Ad26 mosaic HIV Env vaccine for use in Phase 1 studies.
- 3. Complete a toxicology study of the replicating Ad26 mosaic HIV Env vaccine and obtain regulatory clearance to initiate a phase 1 clinical study.
- 4. Conduct phase 1 studies to evaluate the safety and immunogenicity of the replicating Ad26 mosaic Env vaccine in healthy volunteers.