A Study of GENEVAX-HIV, a Possible Vaccine

June 23, 2005 updated by: Wyeth-Lederle Vaccines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Institute of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth-Lederle Vaccines

Investigators

  • Study Chair: Merlin Robb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005
  • 400-003-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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