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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
Est. completion date
Est. primary completion date
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


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, 

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