The primary goal of this program is the development of heteroconjugate peptide vaccines against herpes simplex virus to prevent or treat human infections. The heteroconjugate peptide vaccines will be constructed of epitopes from herpes simplex virus proteins which are recognized by T cells and peptides which are predicted to bind to T cells (T cell binding ligands (TCBL)). The TCBL appears to potentiate the immunogenicity of the antigenic peptide and to guide the course of the immune response to be either more cellular (TH1) or humoral (TH2). These heteroconjugates will be tested for their ability to elicit protective immune responses to HSV-1 and HSV-2 in mouse models for HSV disease. The TCBL are peptide sequences from different lymphocyte surface binding proteins. The successful vaccine will elicit TH1 type (including delayed type hypersensitivity) protective immune responses to viral challenge in mouse models. The HSV vaccines will be prototypes for the development of heteroconjugate vaccines to treat or prevent disease by other infectious agents.
The urgent need for a vaccine for HSV is shown by the over 60,000,000 persons in the U.S. being infected and subject to recurrent HSV infections from laten virus. The first objective, a therapeutic vaccine could be of tremendous benefit in reducing and/or eliminating the severity and number of recurrent infections. The second objective, a preventive vaccine of HSV to eliminate the underlying cause could ultimately have a major impact in eliminating latent infections, if the vaccine induced a sterilizing immunity. The second objective also does not require the first objective of a therapeutic vaccine be reached. Cel-Sci is developing a similar approach for a HIV vaccine and is in phase II trials in Europe for a preventive vaccine to evaluate its immunogenicity. the Company expects to start a phase II trial in Africa within 6 months. Cel-Sci has plans to start a phase I trial for a HIV therapeutic vaccine candidate in the U.S. using this L.E.A.P.S. technology within a year.
| Zimmerman, Daniel H; Steiner 3rd, Harold; Carmabula, Roy et al. (2012) LEAPS therapeutic vaccines as antigen specific suppressors of inflammation in infectious and autoimmune diseases. J Vaccines Vaccin 3: |
