Clinical trial NCT00002232: A Study of GENEVAX-HIV, a Possible Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Institute of Research
state: District of Columbia
Study officials:
name: Merlin Robb
role: STUDY_CHAIR
References: