District of Columbia
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.
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral
and cellular responses are assessed accordingly.
Patients must have:
- Good health.
- Ability to understand the basis of HIV transmission and other common sexual and
- The following parameters within normal range:
- total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and
- BUN and creatinine, urinalysis.
- total serum bilirubin.
- Serum calcium, serum glucose, total serum CPK.
- total serum immunoglobulin and absolute CD4 count.
- Hepatitis B and Hepatitis C negative.
- Normal screen with dipstick for esterase and nitrite.
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)
- 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.
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:
- 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).
Cytotoxic chemotherapy that may affect immune function.
- 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.
- 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)