Personal Information

Name of vaccine developer/PI:

Institution:

Street Address 1:

Street Address 2:

City: State: Country: Postal Code:

Phone: FAX: E-mail:

Vaccine Candidate Information

Name of vaccine candidate to be tested:

A) Provide a complete and detailed description of the experimental agent to be tested, for example:

1. Subunit: describe the product and the production technique
2. Recombinant organisms: the recombinant product (integrated or episomal)
3. Attenuated stain of M. tuberculosis: method of attenuation
4. DNA: describe the product that it encodes, and the nature of the DNA
5. Adjuvant formulations/immunomodulators: a description of the formulation and possible toxic effects

B) For all experimental agents, provide a description of the quality control procedures used in generation of the reagent, particularly those used to ensure purity/sterility and concentration.

C) Provide a specific concentration of endotoxin (where applicable) as determined by the Limulus Lysate Test for experimental agents or indicate that this determination has not yet been made.

D) Provide data for: T- of B-cell response to the antigen, lack of toxicity, preliminary protection assays, attenuation (live candidates), and ability of adjuvant to stimulate an immunological response.

E) Provide a brief description on the planned use or further development of this candidate to assure that optimal data will be generated as part of this contract. For example, plans to develop the reagent for clinical trials or any other use.

F) Please provide pertinent information from an NIH type, two page Biosketch of the Principal Investigator.