SOURCES SOUGHT
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
- 3/27/2014
- Notice Type
- Sources Sought
- 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
- Archive Date
- 4/26/2014
- Point of Contact
- Kim H. Morris, Phone: 7704882621, 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
- This is a Sources Sought Notice. It is NOT an invitiation for bid, solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the capabilities of qualified offerors. The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (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. The applicable NAICS code is 541712 with a size standard of 500 employees. 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. In order to assess the capabilities/experience, the offeror must have proven capabilities in the areas listed below. These areas will be the core requirements for the contemplated contract. (1) Does your company have an OHRP assurance to conduct clinical research on human subjects? (2) Does your company have demonstrated experience in writing a protocol for a vaccine trial that will meet local and federal Institutional Review Board approval? (3) Does your company have demonstrated experience in designing and managing a clinical trial? (4) Does your company have access to an appropriate patient population in order to recruit sufficient subjects such that the sample size for the study groups and controls is adequate to demonstrate a statistically significant effect with consideration of loss to follow-up? (The minimum sample size for each age group (40-49, 50-59, 60-69) is 100 and for the control group (30-39) is 50.) (5) Does your company have demonstrated success in publishing peer-reviewed manuscripts with rigorous data analysis? (6) Does your company have demonstrated experience in confidential collection and proper storage of blood samples; ability to conduct laboratory tests for antibody titers, serology, and liver function? Teaming Arrangements: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses shall be limited to seven (7) pages, excluding the business information, single spaced, minimum Font Size 10, Times New Roman or Arial. Capability statements will not be returned and will not be accepted after the due date. Responses must be submitted via email no later than April 11, 2014, 4:00PM EST to Kim Morris at ycy1@cdc.gov. Telephone calls will not be accepted. Please provide the following Business information: 1. DUNS Number 2. Company Name 3. Company Address 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedule contracts appropriate to this Sources Sought. 8. Current Government Wide Agency Contracts (GWACs). 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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-
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- Record
- SN03322147-W 20140329/140327234732-c08f1df03ab8ce874ed6d1c62f7624cd (fbodaily.com)
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