SOLICITATION NOTICE
A -- FDA Approved Vaccine for Tick-Borne Encephalitis (TBE)
- Notice Date
- 8/23/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- DAMD17-TBE- VACCINE
- Response Due
- 10/31/2002
- Point of Contact
- Cheryl Miles, 301-619-7148
- E-Mail Address
-
Email your questions to US Army Medical Research Acquisition Activity
(cheryl.miles@det.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- NA Request for Proposal: The U.S. Army Medical Research and Materiel Command (USAMRMC) has a requirement for a U.S. Food and Drug Administration (FDA) approved vaccine for protection of personnel against naturally acquired tick-borne encephalitis (TBE). The vaccine must protect against both Central European and Far Eastern TBE strains of virus. This is not intended to be a development effort. The USAMRMC is seeking manufacturers whose vaccines are currently licensed and marketed in one or more countries. The intent of this award is to provide funding in support of obtaining FDA approval of a licensed TBE vaccine. Performance objectives of this vaccine include, but are not limited to: 1) Efficacy ? Minimally, this vaccine must provide protection for a minimus of 1 year in at least 80% of those receiving the prophylaxis; greater than 80% protection for a period of at least 2 years for those receiving prophylaxis is desired. 2) Immune Response ? Minimally, protective immune response shall be developed within 14 days of administering the first series of TBE vaccine; a protective immune response with seven days of administering one dose of TBE vaccine is desired. 3) Shelf Life ? Minimally, this vaccine will have a shelf life of at least one year; a shelf live of t hree years is desired. 4) FDA will license this vaccine for human use. 5) The TBE vaccine will not interfere with other infectious disease prophylaxes or nuclear, biological, and chemical pretreatments and antidotes. It will have no side effects that cause the person receiving the TBE vaccine to be unable to function. 6) No training should be required, other than familiarization and other training already provided to medical personnel for administering similar vaccines. No training devices are required. Thi s effort will require, but is not limited to: 1) obtaining requisite local Institutional Review Board Approval and coordinate with the USAMRMC Product Manager and the Army Office of the Surgeon General Human Subjects Research Review Board to gain approvals to conduct the studies. 2) Developing potential study sites and assign site Investigators possibly in both the U.S. and Europe to support the clinical trial(s) required for U.S. licensure. 3) Conducting the studies under Good Clinical Practice and Interna tional Conference on Harmonization guidelines. 5) Providing the necessary staff, equipment, supplies, etc. to conduct the clinical trial(s) in a manner required for FDA licensure of the TBE vaccine. 6) Preparing the necessary documents required for FDA rev iew and licensure of the TBE vaccine. The Request for Proposal (RFP) will be released on or about 16 Sept 2002. The closing date for receipt of proposal will be approximately 30 days after the RFP is released. The RFP may be accessed on the Internet at www-usamraa.army.mil, Products, Solicitat ions. Questions may be directed to: Director, U.S. Army Medical Research Acquisition ActivityATTN: Ms. Cheryl Miles, , 820 Chandler Street, Fort Detrick, MD 21702-5014. Telephone requests will not be honored.
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Country: US
- Zip Code: 21702-5014
- Record
- SN00148995-W 20020825/020823213703 (fbodaily.com)
- Source
-
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