A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

Study Overview
=================
Brief Summary
-----------------
To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17). A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.

Detailed Description
-----------------
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important. Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.

Official Title
-----------------
A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: gp160 Vaccine (Immuno-AG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects must have: Normal history and physical exam. Negative test for HIV by ELISA within 6 weeks prior to immunization. CD4 count >= 400 cells/mm3. Normal urine dipstick with esterase and nitrate. No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Positive for hepatitis B surface antigen. Medical or psychiatric condition or occupational responsibilities that preclude compliance. Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible). Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible). Subjects with the following prior conditions are excluded: History of anaphylaxis or other serious adverse reactions to vaccines. Prior Medication: Excluded: Prior HIV vaccines. Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood products or immunoglobulin within the past 6 months. Higher risk behavior for HIV infection as determined by screening questionnaire, including: History of injection drug use within 12 months prior to study entry. Higher or intermediate risk sexual behavior.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: gp160 Vaccine (Immuno-AG)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine