A Study of GENEVAX-HIV, a Possible Vaccine

Sponsor

Wyeth-Lederle Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT00002232

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections HIV Seronegativity	Biological: APL 400-003	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Masking:

Double

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)