The US Department of Health and Human Services, National Institutes of Health has a continuing requirement for Operation of a Facility for the Study of Infectious Agents, Vaccines and Antimicrobials in Adult and Pediatric Human Subjects.

The National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Laboratory of Infectious Diseases (LID) have been performing clinical studies in adult and/or pediatric volunteer populations since the 1950’s, with the goal of developing safe and effective vaccines against influenza viruses, human parainfluenza viruses (HPIV), respiratory syncytial viruses (RSV), human metapneumovirus (HMPV), viral agents of gastroenteritis, and flaviviruses. These studies have identified promising candidate vaccines against RSV and other viruses, leading to Cooperative Research And Development Agreements (CRADAs) with commercial collaborators. Safe and immunogenic live-attenuated vaccines against all four dengue virus serotypes were identified and combined into a single-dose tetravalent vaccine, leading to licensing agreements in Brazil, India, Bangladesh, Vietnam, Taiwan, and the US. A Phase 3 study of the lead tetravalent dengue vaccine formulation was recently completed in Brazil, a Phase 3 study is currently underway in India, and other Phase 2 studies are being conducted in Bangladesh, India, and the US. LID and the Laboratory of Viral Diseases (LVD) of NIAID require clinical trials to investigate the safety, immunogenicity, and protective efficacy of vaccines against pneumoviruses, paramyxoviruses (primarily HPIVs), influenza viruses, flaviviruses, alphaviruses, and bunyaviruses, including newly emerging viruses such as Zika virus, noroviruses, rotavirus, and virally-vectored vaccines. Vaccine studies will include adult and pediatric subjects. Clinical trials in adults may also be required for pathogenesis research and to develop viral human challenge models for the testing of antivirals and vaccines.

• The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform requirements described below. The Contractor shall perform clinical and research studies with infectious agents in humans
• The Contractor shall recruit and select healthy adult volunteers and pediatric study participants.
• Facility requirements: Storage of Test Materials
  • The Contractor shall provide facilities for documented and secure temperature-controlled storage of investigational vaccines and challenge virus preparations, and for storage of study specimens
• Facility requirements: Pharmacy
  • `The Contractor shall have United States Pharmacopeia (USP) compliant pharmacy capabilities allowing for preparation of placebo doses, and for aseptic dilution of live virus vaccines and challenge virus material to dose. Institutional approval and Institutional Biosafety Committee (IBC) approval for handling clinical trial material containing biosafety level (BSL) 1 and 2 agents will be required. Pharmacy personnel shall have access to a secure –80°C freezer approved for storage of BSL 1 and 2 agents
• Preparation of Protocols and Regulatory Requirements
  • The Contractor shall prepare clinical protocols and informed consent documents based on draft documents provided by NIAID investigators. The Contractor’s Institutional Review Board (IRB) and IBC shall approve each study, protocol or agent, as necessary. The Contractor shall provide IRB-approved protocols, consent forms, and study advertisements to the NIAID lead study investigator and assist in preparation of Investigator’s Brochures
• Laboratory processing and laboratory analysis
  • The Contractor shall test clinical study specimens to quantify and isolate viral test agents shed by vaccinees, and, in the event of illness, test for the presence of other (wild type) viral or bacterial agents. The Contractor shall perform antibody assays to evaluate immune responses to the virus under study. The Contractor shall separate, cryopreserve, and store peripheral blood mononuclear cells (PBMC) from whole blood if PBMC collection is required under a clinical protocol. It is possible that the required assays would not be available at the Contractor’s facility. In such a situation, the Contractor shall provide a mechanism for transferring the materials to another laboratory
• Data Management
  • The Contractor shall develop and maintain a system of records and data management. Record keeping shall be compliant with all applicable regulations. The Contractor shall establish procedures for tracking recruitment, retention, and follow-up of study patients
• Follow-up
  • The Contractor shall continue the clinical evaluation, collection, analysis, storage and shipment of samples, data collection and reporting on all volunteers enrolled during the Task Order period until the completion of the protocol, or until such tasks can be transferred to a new Task Order award
• Transition Period
  • The Contractor shall, subject to Contracting Officer direction, provide for an orderly transition of data and materials to a successor Contractor or to the Government.