In Phase I antigenic peptide epitopes of HIV-1 p24 and gp41, and of HIV-2 gp34, were identified by synthesizing overlapping peptides representing the entire p24 and gp41 proteins of HIV-1, and portions of p34 of HIV-2, and by screening these peptides for antigenicity by immunoassay. The immunodominant peptides were utilized to develop reagents that detected antibodies to HIV-1 and HIV-2, and a rapid visual test was developed that requires no instrumentation and can be completed in less than ten minutes. Initial results indicate superior sensitivity and specificity of the peptide base assays, compared to currently licensed EIA and rapid tests for detection of antibody to HIV-1. Phase II funding will be used to identify key amino acid residues within each peptide epitope and to optimize these peptides for both immunoreactivity and stability, to prove feasibility in terms of GMP manufacturing requirements, and reproducibility, and to complete FDA regulatory interactions leading to an IND study for licensing of the peptide-based tests. If successful, these tests will provide superior performance to existing methods for the detection of antibodies to HIV.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AI026430-02
Application #
3506050
Study Section
Special Emphasis Panel (SSS (B1))
Project Start
1990-04-01
Project End
1992-03-31
Budget Start
1990-04-01
Budget End
1991-03-31
Support Year
2
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Immunodiagnostics, Inc.
Department
Type
DUNS #
City
Seattle
State
WA
Country
United States
Zip Code
98104