A Study of GENEVAX-HIV, a Possible Vaccine

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002232
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002232 on ClinicalTrials.gov Archive Site
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A Study of GENEVAX-HIV, a Possible Vaccine
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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
Biological: APL 400-003
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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)
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002232
005, 400-003-05
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Wyeth-Lederle Vaccines
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Study Chair: Merlin Robb
NIH AIDS Clinical Trials Information Service
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP