SOLICITATION NOTICE
A -- A Prospective Clinical Trial to Determine the Seroconversion and Immunogenicity of Hepatitis A Vaccine Starting at 15 Days Post-Vaccination in Persons Age > 40 Years
- Notice Date
- 5/12/2014
- Notice Type
- Cancellation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2014-68463
- Point of Contact
- Kim H. Morris, Phone: 770-488-2621, Teri M Routh-Murphy, Phone: 770-488-2713
- E-Mail Address
-
ycy1@cdc.gov, tnr3@cdc.gov
(ycy1@cdc.gov, tnr3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) intends to issue a Request for Proposal (RFP) to support the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP). This will be a new requirement. It is anticipated that the resultant contract will be firm-fixed price and will have a period of performance of thirty-six (36) months. The applicable NAICS code is 541712 with a size standard of 500 employees. The RFP will be posted on FedBizOpps and is expected to be released on or about June 2, 2014. Interested parties are responsible for checking the website regularly for release of the RFP and for other procurement-related documents. TELEPHONE CALLS WILL NOT BE ACCEPTED. The information provided in this pre-solicitation is for information purposes only. If there are any differences in the information provided here and the actual solicitation when released, the information provided in the actual solicitation shall govern. The CDC/NCHHSTP is seeking technical assistance from an offeror with expertise in designing and conducting clinical vaccine trials among older adults to assess the immune response to hepatitis A vaccine in accordance with possible use for post-exposure prophylaxis. The offeror will conduct a clinical trial with approval by the CDC and local Institutional Review Boards (IRB) and in compliance with IRB protocol and other appropriate HHS/CDC requirements for scientific research. Data are lacking on the effectiveness of hepatitis A vaccine for post-exposure prophylaxis among adults 40 years and older. The results of this study will inform development of updated U.S. post-exposure prophylaxis recommendations affecting adults > 40 years of age. The current Advisory Committee on Immunization Practices (ACIP) recommendations state that for persons aged > 40 years, immunoglobulin (IG) is preferred; vaccine can be used if IG cannot be obtained. Hepatitis A vaccine generally is more readily available than IG for immediate use after exposure. Hepatitis A vaccination has the advantage over IG of inducing long-term protection and potential individual benefits, such as knowledge of protection against future exposures. The primary objective is to determine the immunogenicity and safety of hepatitis A vaccination among healthy susceptible adults age ≥ 40 years by decade of life in comparison to a control group of healthy susceptible adults age 30-39 years. Eligible offerors must have the access and capability to conduct research in a clinical setting, including appropriate confidentiality and protection of human subject assurances, and demonstrated experience with applying for and receiving local IRB approval for clinical trials. Eligible offerors will recruit subjects, determine eligibility of subjects, obtain blood samples, perform vaccinations, monitor safety, send aliquoted blood samples to the CDC Hepatitis Reference Laboratory for analysis, inform subjects of the results or laboratory testing, and document immunogenicity. CDC has the following objectives: 1) To write a protocol consistent with the Office for Human Research Protections (OHRP) guidelines for conducting clinical research for a vaccine trial, and that will meet local and federal requirements for IRB approval. 2) To recruit an appropriate study population for the trial as specified in the performance work statement, including obtaining informed consent and collecting a medical history. 3) To collect and properly store blood samples (http://www.cdc.gov/hepatitis/HEV/PDFs/HRL_PCRSampleHndlgShpg_20080615.pdf), and ensure privacy and confidentiality; properly store vaccines (http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-storage.pdf). 4) To have laboratory capabilities to conduct laboratory tests for antibody titers, serology, and liver function. 5) To provide clinical staff who meet legal and licensure qualifications ensuring the ability to administer vaccine. 6) Demonstrated experience to perform scientific data analysis and prepare manuscripts for peer reviewed scientific journals. The offeror shall furnish all the necessary personnel, facilities, supplies, equipment, as appropriate to provide CDC with the required scientific, technical, and operational services, within the general work parameters set forth in the statement of work.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2014-68463/listing.html)
- Record
- SN03363497-W 20140514/140512234311-3c982b77d887b3475d61ccf01626fe37 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |