A Study of GENEVAX-HIV, a Possible Vaccine

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002232
• Other study ID #: 005
• Secondary ID: 400-003-05
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• APL 400-003

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth-Lederle Vaccines

Country where clinical trial is conducted

United States,