A Study of GENEVAX-HIV, a Possible Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.

Detailed Description
-----------------
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.

Official Title
-----------------
GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers

Conditions
-----------------
HIV Infections, HIV Seronegativity

Intervention / Treatment
-----------------
* Biological: APL 400-003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Good health. Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections. The following parameters within normal range: Hematopoietic: total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit. Renal: BUN and creatinine, urinalysis. Hepatic: total serum bilirubin. Endocrine/Metabolic: Serum calcium, serum glucose, total serum CPK. Immunologic: total serum immunoglobulin and absolute CD4 count. Hepatitis B and Hepatitis C negative. Urinalysis: Normal screen with dipstick for esterase and nitrite. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: HIV-seropositive status. Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays. Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results. Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines. Concurrent Medication: Excluded: Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma. Patients with the following prior conditions are excluded: HIV-seropositive. Known or suspected history of impairment or abnormality in immune functioning. Exposure to potentially-infective HIV fluids within the prior 6 months or tested positive for HIV at any time. History of any prior disease or therapy which would affect immune function including: Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix. Immunodeficiency or autoimmune disease. Acute infection or a recent (within 6 months) history of chronic infection. History of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). Prior Medication: Excluded: Cytotoxic chemotherapy that may affect immune function. Prior Treatment: Excluded: Previous immunization with any experimental vaccines directed against HIV or receipt of any experimental agent within 30 days prior to enrollment. Receipt of any blood products or immunoglobulin within 6 months prior to enrollment. Exposure to live attenuated vaccines within 60 days of study. Radiotherapy that may affect immune function. Risk Behavior: Excluded: Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation. Higher- or intermediate-risk sexual behavior (AVEG criteria)

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: APL 400-003|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
-----------------
Injections, Intradermal, Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA, Immunity, Mucosal