MODIFICATION
B -- Herpes Zoster Vaccine Effectiveness for Preventing Postherpetic Neuralgia in Adults 60 Years and Older in a Health Maintenance Organization
- Notice Date
- 7/20/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- 2012-N-14366
- Archive Date
- 7/10/2012
- Point of Contact
- Phil D Alexander, Phone: 770-488-2067
- E-Mail Address
-
pfa5@cdc.gov
(pfa5@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases Branch intends to award, on a sole source basis, a contract to Kaiser Foundation Hospitals, Kaiser Foundation Research Institute, 1800 Harrison Street, Oakland, CA. Herpes Zoster Vaccine Effectiveness for Preventing Postherpetic Neuralgia in Adults 60 Years and Older in a Health Maintenance Organization In 2006 the Advisory Committee on Immunization Practices (ACIP) recommended a single dose of a live, attenuated vaccine against herpes zoster (HZ) for adults 60 years and older. The Shingles Prevention Study (SPS), a placebo-controlled clinical trial of 38,576 adults 60 years and over, showed a 51.3% reduction in the incidence of HZ. Among participants who developed HZ, the vaccine efficacy for preventing zoster-related pain (postherpetic neuralgia, or PHN) 30 days after HZ onset was 15.7%, 18.8% at 60 days, 32.2% at 90 days and 44.4% at 182 days.[1] The main limitations of estimating vaccine effectiveness for preventing PHN (VEPHN) from SPS are: 1) vaccine efficacy was based on clinical trial results under ideal conditions, which may not reflect the true effectiveness of a vaccine in real world settings; and 2) the SPS was not adequately powered to show a statistically significant VEPHN among those with HZ. Administrative healthcare data from large health maintenance organizations offer the opportunity to evaluate the real world VEPHN in a larger study population. However, because administrative healthcare data do not always accurately describe the clinical presentation, validation of cases of PHN found in administrative databases need to be validated through chart review. C.2 Project Objectives - The purpose of this contract is to conduct a chart review to validate the presence of PHN in patients identified with potential PHN in an administrative database. This chart review is necessary for an evaluation of the effectiveness of the HZ vaccine for preventing PHN in a population of immunocompetent adults 60 years and older who received healthcare in a single integrated health system. This evaluation will make it possible to monitor the impact of a zoster vaccine program and inform zoster vaccination policy. Subject acqusition is subject to FAR Part 13. The performance period of subject order will be 2 years from date of order. The government intends to award a Time and Materials contract. The place of performance is the contractors facilities. Market research indicates that Kaiser Foundation Hospitals, Kaiser Foundation Research Institute is the only institution that can provide the study. This is not a request for competitive proposals and no solicitation is available. All responsible sources that believe they can provide the services are encouraged to identify themselves and submit a capability statement to the Contracting Officer within 10 days of the publication date of this notice. A determination by the Government not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining to conduct a competitive procurement. All vendors/prospective contractors must be registered with the Central Contractors Registration (www.ccr.gov) prior to award date. If not registered or active by that date, vendor proposals will be considered non-responsive. Inquires may be sent to Phil Alexander by e-mail at PFA5@CDC.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2012-N-14366/listing.html)
- Place of Performance
- Address: 1800 Harrison Street, Oakland, California, 91101, United States
- Zip Code: 91101
- Zip Code: 91101
- Record
- SN02810926-W 20120722/120721000111-dd96d87082f5270a039b32462b3d8df6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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