SOURCES SOUGHT
A -- Conduct of Multicenter Phase III Efficacy Trial of HSV Vaccine Against Genital Herpes Disease
- Notice Date
- 2/7/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700-B Rockledge Drive, MSC 7612 Room 2230, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-45250
- Response Due
- 3/23/2002
- Archive Date
- 4/7/2002
- Point of Contact
- Elizabeth Osinski, Contract Specialist, Phone 301-402-6289, Fax 301-402-0972, - Lawrence Butler, Contracting Officer, Phone 301-496-0192, Fax 301-402-0972,
- E-Mail Address
-
eo43m@nih.gov, lb13t@nih.gov
- Description
- The National Institute of Allergy and Infectious Diseses (NIAID) intends to negotiate a modification to its contract with St. Louis University, N01-AI-45250. This contract is a Vaccine Treatment Evaluation Unit (VTEU) for evaluation of control measures against infectious diseases other than AIDS. Under this modification, NIAID plans to conduct a multicenter Phase III efficacy trial of HSV vaccine against genital herpes disease. GlaxoSmithKline (GSK) has developed and patented a candidate genital herpes vaccine (rgD-Alum/MPL) which has been evaluated with its own funds in a full clinical development path, including two Phase III efficacy trials. Through a Cooperative Research and Development Agreement (CRADA) partnership with GSK, the Division of Microbiology and Infectious Diseases (DMID), NIAID, proposes to conduct a pivotal vaccine efficacy trial to prevent genital herpes disease in women. The trial will enroll approximately 7,000 women and will take 4 years to complete. GSK and NIAID will share equally in the costs of the trial. The St. Louis VTEU will subcontract with approximately 15 other institutions to fulfill the required 7,000 subject enrollment. As part of the CRADA negotiation, NIAID undertook a feasibility assessment for the conduct of this trial. The outcome of this assessment was that between the 15 sites that participated, it was feasible to enroll the projected 7,000 eligible subjects. These institutions are proposed as subcontractors to St. Louis University and they are as follows: University of North Carolina, University of Texas Medical Branch, Baylor College of Medicine, UCLA, University of Rochester, University of Colorado, Indiana University, Johns Hopkins University, University of Maryland, Louisiana State University School of Medicine, University of Pittsburgh, University of Utah, University of Alabama at Birmingham and the University of Washington. Each of these institutions has substantial infrastructure to support a clinical trial of this nature, and investigators with documented experience and expertise in vaccine evaluation, infectious disease and complex interventional clinical trials. The number of subjects needed in a recruitment time of 18 months demands a multicenter effort, an institutional management infrastructure to coordinate this effort, and a skilled Principal Investigator with documented experience and expertise in the conduct of multicenter vaccine efficacy trials. The NIAID St. Louis VTEU fills the institutional management requirements and Dr. Robert Belshe, PI of this contract, has documented infectious disease training and experience, and extensive experience in the development and clinical evaluation of vaccines. The St. Louis VTEU represents significant infrastructure that the Government has already secured and supported for many years. St. Louis University has a relevant study population in the geographic environs and will contribute a significant number of the clinical trial subjects. As PI of the ST. Louis VTEU, Dr. Belshe has taken the lead in clinical protocol development and served as lead study clinician in regulatory meetings with the FDA. Through St. Louis University and the other subcontractors named above, known study populations are accessed. If this clinical trial were competed, there would be wasteful and unnecessary duplication of costs to rebuild the infrastructure we already have in place. As part of the CRADA negotiations, the government committed to begin subject enrollment by July 2002. This can only be accomplished by working with existing and known material and personnel infrastructure. To do anything other than this will severely impact on time and cost and will result in unacceptable CRADA contractual delays. Authority: 41 U.S.C. 253 (c) (1), as set forth in FAR 6.302-1. See numbered Note 22. No collect calls will be accepted. Point of Contact: Elizabeth Osinski, Contract Specialist, N6700-B Rockledge Drive, MSC 7612, Room 2230, Bethesda, MD 20892-7612 E-Mail Address: eo43m@nih.gov Phone 301-402-6289 CITE: (
- Record
- SN00023783-W 20020209/020207213131 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |