Vaccine and Treatment Evaluation Units (VTEU) Protocol Development and Implementation for a Phase II Therapeutic Trial for Trichuris Trichiura

NIH RePORTER · NIH · N01 · $1,533,541 · view on reporter.nih.gov ↗

Abstract

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.

Key facts

NIH application ID
11176665
Project number
272201300020I-P00002-759301900131-1
Recipient
UNIVERSITY OF IOWA
Principal Investigator
PATRICIA WINOKUR
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$1,533,541
Award type
Project period
2019-05-29 → 2027-09-30