Inactive

The mission of the Vaccinee Research Center (VRC), NIAID is to develop vaccines to protect against infectious diseases that are public health threats. The BRC research includes developing novel vaccin... The mission of the Vaccinee Research Center (VRC), NIAID is to develop vaccines to protect against infectious diseases that are public health threats. The BRC research includes developing novel vaccines and using different methods to optimize their effectiveness. An adjuvant is a substance that is formulated as part of a vaccine to enhance its ability to induce protection against infection. As one component of the VRC’s research, the VRC, NIAID, NIH has been investigating the use of novel adjuvants in our vaccine development program for HIV, influenza and other viral vaccines, and has found the “Adjuplex brand” of adjuvant from Advanced BioAdjuvants LLC (ABA) to be superior to other adjuvants. The VRC has used the Know How, information and technical assistance provided by Advanced BioAdjuvants LLC (ABA) to manufacture in the original license from an earlier acquisition dating to 2019 to produce and develop the Adjuplex adjuvant, which was used to manufacture clinical grade (cGMP) Adjuplex for use in VRC’s HIV, influenza, and other viral vaccine trials. The Know How, unpublished company-owned information, technical assistance and documents required for regulatory approval about production are only available from ABA. This is a follow-on requirement to an acquisition from 2019 (which had options extending to September 25, 2021) that used this product for research/studies, clinical trials, etc. Thus, the VRC must continue using this same vendor and same product in order to maintain consistency and progress to later or more advanced stages of the trials and studies. Reference attached Limited Source Justification.