SOLICITATION NOTICE
B -- Study of seropositivity and subsequent risk of HPV16 and 18 infections using a novel assay
- Notice Date
- 9/2/2009
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90233-KM
- Archive Date
- 10/2/2009
- Point of Contact
- Karri L. Mares, Phone: 3014357774, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
maresk@mail.nih.gov, cr214i@nih.gov
(maresk@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis a study of seropositivity and subsequent risk of HPV16 and 18 infections using a novel assay from PPD Vaccines & Biologics, 466 Devon Park Drive, Wayne, PA 19087. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541380 and the business size standard is $12 M. The period of performance shall be twelve (12) months from date of award. It is not known whether antibodies produced against natural infection with the human papillomavirus (HPV) confer protection/immunity from subsequent HPV infection. Studies conducted to date to examine this possibility have been inconclusive. The lack of consistency in the literature to date is likely to be partly explained by the fact that levels of antibodies generated following natural infection are many orders of magnitude lower than those generated through vaccination, resulting in levels of protection that are partial, at best, and therefore difficult to detect. Furthermore, pre-vaccination era antigens used in the assays measuring serologic response were less pure than currently available reagents, resulting in misclassification that made detection of effects in natural history studies even more difficult. Additionally, the published serologic natural history studies were based on serologic assays that measured polyclonal responses and not the specific antibodies that are likely to have neutralizing potential and to therefore be of greatest interest. More recently developed HPV serology tests specifically target the measurement of antibodies directed against known HPV-16 and HPV-18 neutralization sites. One of these assays was developed by Dr. Mark Esser at PPD Vaccines & Biologics laboratory and is now commercially available. Unpublished data from unvaccinated women in the control group of the Merck vaccine trials demonstrate that unvaccinated women testing positive on the Esser assay are at extremely low risk of subsequent HPV infection and CIN for the 4 HPV types (HPV 6, 11, 16, 18) covered by the assay. The Division of Cancer Epidemiology and Genetics of the National Cancer Institute, in collaboration with investigators from several institutions in Costa Rica, launched a community-based randomized phase III clinical trial to evaluate the efficacy of a prophylactic HPV vaccine, involving a cohort of 7,466 vaccinated women (referred to henceforth as the Costa Rica HPV Vaccine Trial or CVT). The main objectives are to evaluate the efficacy of the HPV-16/18 bivalent vaccine against incident HPV-16/18 persistent infection, against infections by other HPV types (cross-protection) and HPV-16/18-positivie CIN2+, as well as to evaluate the safety of the vaccine. Under this procurement, the contractor will process and test serum from an initial set of 525 samples with their specific serology assay for HPV16, HPV18, HPV6, and HPV11. An additional 300 serum samples will also be tested with the same assay following testing of the initial 525. If it is confirmed that this assay measures protection/immunity to subsequent HPV infection for that type of HPV (4 types being measured), the assay will be used on additional samples to investigate important research questions such as the longitudinal patterns of antibody titers and duration of protection conferred by natural infection. Dr. Mark Esser and his group, developed this competitive ELISA assay while working for Merck; the development was part of Merck’s effort to measure immunity in their HPV vaccine studies. The laboratory was sold to PPD Vaccine and Biologics (PPD) who now has proprietary rights for its use. At the recent International Papillomavirus Meeting in Malmo it was confirmed that no other laboratory offers this assay. Accordingly, PPD is the only laboratory that can perform these assays and is uniquely qualified to perform the work under this contract. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11: 00 a.m. EST on September 17, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Karri Mares maresk@mail.nih.gov. It is the vendor’s responsibility to ensure questions have been received by the contract specialist. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference solicitation No. NCI-90233-KM on all correspondence.
- Web Link
-
FBO.gov Permalink
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- Record
- SN01938671-W 20090904/090903002132-ce58eaba305218163ee659ad1ea38ed9 (fbodaily.com)
- Source
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