Operation of a Facility for the Study of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- NIHAO201800107
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- Not on record
- Place of performance
- National Institutes of Health National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, Maryland 20892, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This solicitation seeks proposals to operate a clinical research facility to conduct vaccine studies in adult and pediatric populations. The National Institutes of Health, National Institute of Allergy and Infectious Diseases, and Laboratory of Infectious Diseases are seeking to develop safe and effective vaccines against influenza, respiratory syncytial virus, parainfluenza, metapneumovirus, viral gastroenteritis, flaviviruses, and dengue virus. Proposals are due November 13, 2018 and the contract will be awarded to one vendor operating the facility and conducting vaccine trials over a period to be determined. Evaluation criteria include technical approach, personnel qualifications, and past performance. Questions were accepted through November 9th.
The contract has no set-aside designation and involves clinical research facility management and operation under NAICS 541715 and PSC D304. The period of performance is to be determined with a minimum value of $10 million and maximum of $73 million over the life of the contract to be performed at 5601 Fishers Lane, Bethesda, Maryland. Budgets must be submitted for core support, pediatric studies, adult outpatient studies, and adult inpatient studies. Safety databases and statistical analysis are required for all sample task orders valued between $100,000 and $5 million each.
Notice text
5 versions
Update #5 · Latest ·
Amendment 3 Questions and Responses 11/9/18
Amendment 4 Correction to Amendment 3 11/9/18.
Update #4 ·
Amendment 3 Questions and Responses 11/9/18.
Update #3 ·
Amendment 1 Questions and Responses 10/12/18
Amendment 2 Questions and Responses 10/17/18.
Update #2 ·
Amendment 1 Questions and Responses 10/12/18.
Update #1 ·
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, Vietnam, Taiwan, and the US. A phase 3 study of the lead tetravalent dengue vaccine formulation is currently under way in Brazil, and Phase 2 studies are being performed in Bangladesh and Thailand..
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Notice history
| Notice | Type | Posted |
|---|---|---|
| Operation of a Facility for the Study of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects For NIAID | Award Notice | |
| This notice | Solicitation |
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