This research program is a collaboration between a team of academic scientists who have developed an innovative HIV vaccine strategy, and a biotechnology company based upon a unique delivery vehicle, cochleates, that facilitates the oral delivery of drugs, antigens, and genes. The long term objective is to develop a unique, safe and effective prophylactic/therapeutic HIV subunit vaccine with the following advantageous characteristics: i- orally administered; ii- stable at room temperature; iiiinduces protective, HIV-specific, cell mediated immunity; iv- induces systemic and mucosal immune responses; and v- is inexpensive. The hypothesis upon which this SBIR Phase I research proposal is based is that oral administration of cochleate formulations containing a cocktail of synthetic HIV peptides will induce systemic helper and cytotoxic T lymphocyte responses in a mouse model. This hypothesis will be tested by performing the following specific aims:
Aim 1 : To determine which form of the synthetic peptides, plain or lipid tailed, induce the strongest CMI.
Aim 2 : To determine which structure of the delivery vehicle, liposome or cochleate, induces the strongest CMI.
Aim 3 : To determine the immunopotentiating effects of the SDE adjuvant/immunomodulator with these peptides.
Aim 4 : To characterize the immunogenicity of oral administration of the peptide-cochleate vaccine formulation. The overall study design will be to prepare the various peptide-adjuvant-delivery vehicle formulations, administer them to BALB/c mice, and assay for proliferative and cytolytic T cell responses.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43AI051905-02
Application #
6643479
Study Section
Special Emphasis Panel (ZRG1-VACC (10))
Program Officer
Bradac, James A
Project Start
2002-08-15
Project End
2006-07-31
Budget Start
2003-08-15
Budget End
2006-07-31
Support Year
2
Fiscal Year
2003
Total Cost
$300,000
Indirect Cost
Name
Biodelivery Sciences International, Inc.
Department
Type
DUNS #
City
Newark
State
NJ
Country
United States
Zip Code
07103