U.S. TRIAL OF ACELLULAR PERTUSSIS VACCINE NIH GUIDE, Volume 21, Number 24, June 26, 1992 RFP AVAILABLE: NICHD-OD-92-16 P.T. 34 Keywords: Vaccine Clinical Trial National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) is planning a clinical safety trial using a DTP vaccine in which the pertussis component is the acellular pertussis toxoid developed by NICHD scientists. An efficacy trial of this DTP is currently underway in Goteborg, Sweden. The safety trial is to begin in January 1993. The study will include three lots of the investigational DTP vaccine (the products of three separate manufacturing runs) and one lot of commercial whole-cell DTP. These vaccines will be randomly labelled A, B, C, and D and will be bottled in single-dose vials. Each lot of vaccine will be sufficient to immunize 1,000 infants at 2, 4, and 6 months of age. In summary, 4,000 infants will be immunized, with 1,000 each receiving either vaccine A, B, C, or D. The entire process will be completed for each child within a period of four months. The offeror must be able to recruit and immunize at least 1,000 infants (ideally the offeror could recruit and immunize all 4,000) over the time period of the resulting 12 months. The offeror will be expected to randomly identify a 10 percent sample of infants to be bled for antibody measurements. One-third of the selected infants will be bled one month after the first injection, one-third one month after the second injection, and one-third one month after the third injection. In addition, blood samples will be taken from a five percent randomly identified group of infants before the first injection at two months of age. All blood samples will be stored as frozen serum (4xF) and shipped frozen to the NICHD as directed by the Project Officer. The NICHD will be responsible for serological analyses. This announcement is a new solicitation. The issuance of this Request for Proposals (RFP) will be on or about June 26, 1992, and proposals are due by 4:00 p.m. (local time), August 27, 1992. The Institute plans to award one to four contracts, depending on the number of recruits that the successful offerors plan to select. Those organizations desiring a copy of the above RFP may send written requests to: Mrs. Lynn Salo Office of Grants and Contracts Contract Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 7A07A 9000 Rockville Pike Bethesda, MD 20892 All requests must cite the RFP number above and include two self- addressed mailing labels. All sources who consider themselves qualified are encouraged to submit a proposal. This advertisement does not commit the Government to make an award. .
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