A Study of GENEVAX-HIV, a Possible Vaccine
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
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.
Biological: APL 400-003
||Endpoint Classification: Safety Study
Primary Purpose: Prevention
||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
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
|Ages Eligible for Study:
||18 Years to 60 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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:
- total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit.
- 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) 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.
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002232
|Walter Reed Army Institute of Research
|Washington, District of Columbia, United States, 20307 |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Immunologic
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2016
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Physiological Effects of Drugs