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A P. falciparum MSP1 p42/QS-21 malaria vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: PHS2001-2
Agency Tracking Number: 1R41AI049641-01
Amount: $302,541.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
34 COMMERCE WAY WOBURN, MA 01801-1065
WOBURN, MA 01801
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 SANDRA CHANG
 (808) 732-1477
 sandrac@hawaii.edu
Business Contact
 PACKARD, MELISSA
Phone: (781) 721-3518
Email: MPACKARD@AQUILABIO.COM
Research Institution
 UNIVERSITY OF HAWAII
 
UNIVERSITY OF HAWAII
HONOLULU, HI 96750
United States

 Nonprofit College or University
Abstract

DESCRIPTION: (Adapted from Applicant's Abstract) Malaria is a disease which
affects more than 300 million people each year and is fatal for 1.5 million.
The overall objective of this STTR Phase I project is to produce a cGMP malaria
vaccine consisting of the 42 kDa C-terminal polypeptide of P. falciparum
merozoite surface protein-1 (MSP1.42) to be formulated with QS21 adjuvant for
preclinical studies and a future clinical Phase I trial. Evidence is presented
that MSP1.42/QS-21 protects against P. falciparum malaria in the Aotus monkey
model. Data is also presented supporting the feasibility of large-scale MSP1.42
production in the baculovirus system and its purification by standard
chromatography. The goals of the project are (1) production of master cell
banks of insect cell lines for virus stock and polypeptide production,
respectively; (2) preparation of a virus stock of recombinant MSP1.42
baculovirus; (3) production of bulk MSP1.42 antigen in a bioreactor; (4)
purification of MSP1.42; (5) establishment of analytical methods to define
product specifications; and (6) evaluation of the immunogenicity of the cGMP
MSP1.42/QS21 formulation in mice and Aotus and of its efficacy in Aotus. These
studies will provide cGMP material and preclinical information for a clinical
trial of MSP1.42/QS21 during STTR Phase II.
PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

* Information listed above is at the time of submission. *

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