The National Institute of Allergy and Infectious Diseases is re-competing its contract for the Division of AIDS (DAIDS) Virology Core Lab.
Animal models present the opportunity to test a variety of candidate HIV and other infectious disease vaccines. Preclinical studies, and in particular, nonhuman primate (NHP) studies are key to evaluate the immunogenicity, efficacy, and toxicity of vaccine candidates, de-risk the product/platform in costly GMP manufacturing, and lastly, help to inform and guide Phase 1 clinical trial studies.
Contracts for the Simian Vaccine Evaluation Units (SVEUs) and four centralized Core Laboratories currently evaluate the immunogenicity and efficacy of candidate AIDS vaccines in NHPs. The SVEUs conduct the studies: acquiring and housing the animals, developing the protocols, administering the vaccine, and collecting the samples. The Core Laboratories conduct cellular and humoral immunology, virology, and functional genomic assays to comprehensively assess the immunogenicity of the candidate vaccines and for potential identification of protective immune responses in efficacy studies. Thus, the objective of the four Core Laboratories is to ensure standardization of the assays and to provide a common basis for comparability of results across different studies.
The contract for the Functional Genomics Core Laboratory is held by the University of Washington. The Cellular Immunology Core Laboratory contract is held by Tulane University. Lastly, Duke University holds the contract for the Humoral Immunology Core Laboratory, as well as the contract for the Virology Core Laboratory. The Virology Core Laboratory (VCL) has a period of performance of Dec 22, 2017 through Dec 14, 2024 and is the focus of this solicitation.
The primary purpose of the VCL is to measure viral RNA levels in samples in support of a candidate AIDS vaccine (or other intervention) being tested. The VCL produces a large volume of well characterized SIV, SHIV, and HIV viral stocks that serve as standard reagents for the scientific community.
The contractor will conduct assays to characterize and quantitatively determine the level of SIV, SHIV, or HIV viral RNA in samples such as plasma, mucosal tissues or secretions, lymphoid tissues, or other tissues derived from animals and in samples from in vitro virus cultures and virus stocks.
In vivo studies are anticipated to largely include NHP animal studies but may extend to small animal models including mouse models or others as directed.
Assays to detect viral RNA for other infectious agents may be requested.
Proposals for the Virology Core Lab are due by 7 Dec 2023.