Expired Study
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Baltimore, Maryland 21205


Purpose:

The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection. This study examines a new oral vaccine to see if it can improve the immune system's ability to fight the HIV virus when given alone or with another injected vaccine.


Study summary:

Although recent advances have been made in antiviral therapy for AIDS, there is no cure for HIV-1 infection or AIDS, and drug therapy is too expensive for most affected populations. The development of safe, effective vaccines to prevent HIV-1 infection and AIDS worldwide is a global priority. One promising approach in the development of HIV-1 vaccines utilizes live vaccines as vectors to express HIV-1 antigens. The potential advantages of the live vector approach include the ability of live vector recombinants to induce long-lasting humoral and cell-mediated immunity (particularly neutralizing antibody and CD8+ cytotoxic T-cell activity) and the relatively low cost of production. Moreover, live vector recombinant vaccines administered orally might be able to stimulate the production of secretory IgA vaccine-specific antibodies locally at relevant mucosal sites. Part I of this study is conducted as an open-label, dose-escalation trial. The first 5 volunteers (Group A) receive a single oral dose of Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG203). If no typhoid fever-like illness is seen in these volunteers during at least 14 days of follow-up, the next 5 patients (Group B) receive a single dose of VVG203. If this higher dose is well-tolerated, Phase II of the study is initiated once all Phase I volunteers have been assessed for safety for at least 21 days. [AS PER AMENDMENT 11/07/97: Groups A and B are expanded to 10 patients each.] Part II of this study is a randomized, placebo-controlled, double-blind trial. Nine volunteers are randomized to each of treatment groups, with oral VVG203 given alone or sequentially with HIV-1 SF-2 rgp 120 in MF59 (SF) given intramuscularly. [AS PER AMENDMENT 11/07/97: Randomization is to VVG 203 alone or sequentially with HIV-1 MN rgp120 in alum (MN).] A total of 3 vaccinations are administered within each 9-person cohort, 1 volunteer serves as a control and receives a sodium bicarbonate buffer rather than VVG203 or a vaccine placebo rather than SF. Group C receives VVG at Month 0 and SF at Months 2 and 6. Group D receives VVG at Months 0, 2, and 6. Group E receives SF at Months 0 and 2 and VVG at Month 6. [AS PER AMENDMENT 11/07/97: MN is given in place of SF in all Groups C, D, and E.]


Criteria:

Inclusion Criteria You may be eligible for this study if you: - Are 18-50 years old. - Are HIV-negative. - Are healthy and have a normal history and physical exam. - Agree to practice abstinence or use of effective birth control for 1 month before and during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a history of immune deficiency, chronic illness, or autoimmune disease. - Have received immunosuppressive medications, blood products, trial drugs, immunoglobulins, or an HIV or typhoid vaccine. - Have a history of severe allergic reactions. - Have had prior suicidal attempts or have a psychiatric condition or job commitments which would prevent you from completing the study. - Have a history of cancer (unless the cancer has been successfully cured), gallbladder disease, typhoid fever, migraines or other severe headaches, cardiac valve defects, or congenital heart disease. - Have active syphilis or tuberculosis. - Are allergic to certain medications. - Are pregnant or breast-feeding. - Have household contact with infants or persons who are pregnant, immunodeficient, or HIV-positive. - Are unavailable for 12 months of follow-up. - Have hepatitis B. - Have a history of injection drug use within 12 months of enrollment or have higher or intermediate risk sexual behavior.


NCT ID:

NCT00000868


Primary Contact:

Study Chair
M Clements


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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