NIH GUIDE, Volume 23, Number 28, July 29, 1994


P.T. 34




National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID) is

soliciting the interest of manufacturers of pneumococcal conjugate

vaccines or other new candidate pneumococcal vaccines to have their

products considered for use in Phase II and Phase III clinical trials

in developing and intermediate countries.  Although sources of

pneomococcal vaccine are sought, no contract will result from this


To be considered, conjugate vaccines must be multivalent and contain

the following serotypes: 1, 5, 6B, 14, 19F, and 23F in addition to 9V

and/or 18C.  Data must be available demonstrating successful Phase I

clinical trials in infants with an experimental lot of vaccine

containing at least four of the above serotypes in addition to

information that the vaccine meets U.S. FDA licensing requirements.

Quantities of vaccine sufficient to conduct a large scale Phase III

trial must also be made available by June 1995 without cost to the

government.  Manufacturers are required to provide information on basic

manufacturing methods and the total content of the candidate

pneumococcal vaccines including the type of adjuvant and preservative

used, the type of carrier protein, and the chemical constructs.

Selected products will be evaluated for safety and immunogenicity in a

pre-determined Phase III trial site in addition to several of NIAID's

contracted Vaccine Evaluation and Treatment Units.  If more than one

product is under consideration, the products will be compared to each

other for safety and immunogenicity to facilitate the selection of a

vaccine for eventual use in the field trial.  The NIAID plans to

cross-reference the manufacturer's Investigational New Drug (IND)

exemption application or Master File for information to support studies

submitted under NIAID's IND.


Interested parties are encouraged to respond by September 30, 1994.

Respondents are invited to discuss additional terms or conditions with

NIAID by contacting:

David L. Klein, Ph.D.

Division of Microbiology & Infectious Diseases

National Institute of Allergy & Infectious Diseases

Solar Building, Room 3B03

6003 Executive Boulevard, MSC 7630

Bethesda, MD  20892-7630

Telephone:  (301) 496-5305

FAX:  (301) 496-8030


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