Trial record 9 of 379 for:    "HIV Seronegativity" [CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV Infections
HIV Seronegativity
Biological: APL 400-003
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
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

Locations
United States, District of Columbia
Walter Reed Army Institute of Research
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Wyeth-Lederle Vaccines
Investigators
Study Chair: Merlin Robb
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002232     History of Changes
Other Study ID Numbers: 005, 400-003-05
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Injections, Intradermal
Injections, Intramuscular
HIV Antibodies
Immunity, Cellular
AIDS Vaccines
HIV Seronegativity
Dose-Response Relationship, Immunologic
Vaccines, DNA
Immunity, Mucosal

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014