The National Institute of Allergy and Infectious Diseases (NIAID) intends to solicit proposals for contracts entitled “Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects” to advance development of candidate malaria vaccines in order to reduce the number of malaria cases worldwide.
NIAID’s Laboratory of Malaria Immunology and Vaccinology (LMIV) requires clinical trials to investigate initial safety, immunogenicity, and biologic impact of promising vaccine candidates. Clinical trials may also be conducted as part of pathogenesis research to facilitate vaccine development. These may include a Phase 1 Malaria Vaccine Trial, Phase 1-2 Challenge Trials, and Experimental Infection Trials.
The overarching goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and will eliminate malaria from low-transmission areas of the world.
Draft clinical protocols will be provided by LMIV investigators. LMIV will develop protocol objectives and overall design. The selected contractor will then assist in completing the final draft protocol. Upon LMIV review of the final draft, the Contractor will be responsible for submitting each protocol to the Contractor’s Institutional Review Board (IRB) and obtaining approval.
Where investigational applications are required, approved protocols will be filed with the Center for Biologics Evaluation & Research of the Food and Drug Administration (FDA) by NIAID as part of an Investigational New Drug (IND) Application.
NIAID expects to issue task orders for clinical trials of LMIV’s promising vaccine candidates under approximately 5 Indefinite Delivery Indefinite Quantity (IDIQ) Contracts. These IDIQ contracts are expected to be awarded in June of 2015 for a period of 5 years.
The official Request for Proposals is expected to be issued later this week. Further details are available via Solicitation Number: HHS-NIH-NIAID-(AMOB)AO-P-2015-023.
