NIH GUIDE, Volume 21, Number 24, June 26, 1992


P.T. 34



  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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