A Study of GENEVAX-HIV, a Possible Vaccine

NCT00002232 | Completed Phase 1

• 2 other identifiers: 005400-003-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Injections, Intradermal; Injections, Intramuscular; HIV Antibodies; Immunity, Cellular; AIDS Vaccines; HIV Seronegativity; Dose-Response Relationship, Immunologic; Vaccines, DNA; Immunity, Mucosal

Interventions

APL 400-003 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth-Lederle Vaccines: lead

Study Sites (1)

Walter Reed Army Institute of Research

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Merlin Robb

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1999-06

Locations

US (1)