65 -- PRODUCTION OF VIRUS-LIKE PARTICLES FOR HPV VACCINE TRIALS=20

Notice Date

July 9, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 608G, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

RFQ-NCI-10035-NG

Response Due

July 30, 2001

Point of Contact

Todd Cole, Contracting Officer, Phone (301) 402-4511, Fax (301) 402-4513, Email tc51u@nih.gov -- Malinda Holdcraft, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, Email mh139x@nih.gov

Description

The National Cancer Institute (NCI) proposes to contract with Novavax, Inc. (formerly Dyncorp), 8320 Guilford Road, Suite C., Columbia, MD 21046 to provide recombinant human papillomavirus (HPV) type HPV16 L1/L2-E7-E2 chimeric(c), virus-like particles (VLPs). Bulk and final container products of HPV16 L1/L2-E7-E2 cVLPs are required for ongoing clinical trials. The supplies and services herein are commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program for using simplified procedures for certain commercial items as authorized in FAR 13.5. To date, Novavax has manufactured all first generation, clinical grade virus-like particles for the HPV Phase I and Phase II vaccine trials, as well as for a planned large scale efficacy trial. Based on the preclinical studies to date, it is hoped that the required second generation cVLP vaccine will have the attributes of the HPV16 L1 VLP vaccine, plus the ability to induce additional protection against HPV16 infection by induction of immune responses to the non-structural viral proteins in the cVLP vaccine. To date, Novavax, has manufactured all HPV16 L1 VLPs for the HPV Phase I and Phase II vaccine trials under previous purchase orders, 263-MQ-918990 and 263-MQ-013844. The Laboratory of Cellular Oncology has been collaborating with NIAID in these trials, which are near successful completion (Protocol #CB-09052-06). Novavax is the only known source that has produced these particular, virus-like particles via good manufacturing practices and with FDA approval for use in clinical trials. NCI now plans to directly compare the efficacy of the HPV16 cVLP vaccine with that of the HPV16 L1 VLP, a closely related vaccine, in a large scale efficacy trial. For the comparison to be meaningful, it is essential that the cVLP vaccine be manufactured by a process that mimics, to the greatest degree possible, the process used for manufacture of the L1 VLPs. While similar virus-like particles are also made via a commercial process, production by any other source may result in the introduction of new and unknown variables that could inhibit study results, as well as the comparability of study data. In addition, delays in the clinical trials could result, as no other firms are believed to have the requisite approval from FDA to produce this particular recombinant. Based on the above, the Government believes that Novavax is the only source that can provide the necessary HPV16 L1/L2-E7-E2 chimeric, virus-like particles as bulk and final container products. This contract is being solicited on a fixed price basis for 27,000 vials (0.75 ml each) of HPV16 L1/L2-E7-E2 chimeric VLP final container products using commercial item procedures and under the authority of 41 U.S.C. 253 (c)(1), as set forth in FAR 6.302-1 and HHSAR 306.302-1. Only one responsible source and no other supplies will satisfy agency requirements. Interested parties may identify their interest and capability to respond to this requirement. This notice of intent is not a request for competitive quotations. However, all capability statements received within 20 days after publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed requirement based upon response to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If you have any questions, please contact Todd Cole, Contracting Officer on (301)-402-4509

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/RFQ-NCI-10035-NG/listing.html)

Record

Loren Data Corp. 20010711/65SOL003.HTM (D-190 SN50R2D5)