NCT00002232已完成1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •BUN and creatinine, urinalysis.
- •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.
排除标准
- •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:
- •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:
- •Cytotoxic chemotherapy that may affect immune function.
- •Prior Treatment:
- •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:
- •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)
研究者
研究点 (1)
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