Long Term Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine

NIH RePORTER · NIH · N01 · $625,721 · view on reporter.nih.gov ↗

Abstract

NIAID Preclinical Development Support: The purpose of this contract is to provide all aspects of the development, manufacture, IND enabling preclinical testing, and the production of regulatory documents for prototype HIV-1 prophylactic vaccines for human clinical trials. This includes all types of HIV-1 vaccines including DNA plasmids, viral vectors, and protein antigens. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps for HIV vaccines. Activities would be for he small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Activities include assisting in the identification, testing, and development of products; participation in and managing preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products. This Task Order is for initiation and execution of the Long-Term Stability Program for a nanoparticle-based HIV envelope containing vaccine.

Key facts

NIH application ID
11122003
Project number
272201700010I-0-759302400002-1
Recipient
ADVANCED BIOSCIENCE LABORATORIES, INC.
Principal Investigator
Timothy R Fouts
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$625,721
Award type
Project period
2017-06-10 → 2024-06-09