Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed)
HHS-NIH11
Status:
Active
October 31, 2022
Posted:
Deadline:
March 14, 2025
Funding
Program:
Award Floor:
Ceiling:
3000000
Match Required?
No
Eligibility
All
States:
Entity Types:
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)
The purpose of this Funding Opportunity Announcement (FOA) is to support translation of advanced HIV-1 vaccine candidates from pre-clinical studies through different phases of process and product development, Current Good Manufacturing Practice (CGMP) manufacturing and regulatory filing to the point of clinical testing. The FOA will support technology transfer, preclinical immunogenicity and optimization studies, process development, analytical assay development, qualification, validation, testing, small scale pilot or engineering runs, CGMP manufacture in partnership with Pharma/Biotech/Contract Manufacturing Organizations (CMO), quality assurance/quality control oversight, fill-finish activities, product release and storage, generation of reference standard, drug substance and drug product stability testing programs, Investigational New Drug (IND)-enabling studies, regulatory submission preparation.