A Study of GENEVAX-HIV, a Possible Vaccine

Wyeth

Status and phase: Completed; Phase 1

Conditions: HIV Infections; HIV Seronegativity

Treatments: Biological: APL 400-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002232

400-003-05

005

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)