Screening Protocol for HIV Vaccine Studies
Screening Subjects for HIV Vaccine Research Studies
Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS.
Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled.
Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study:
- Medical history, including history of sexual activity and drug use
- Physical examination
- Pregnancy test for women of childbearing age
- Blood and urine tests to evaluate possible medical problems such as liver and kidney function; to evaluate immune function; and to test for HIV, hepatitis and syphilis
Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.
調査の概要
詳細な説明
Study Design: The purpose of this study is to screen subjects to determine if they are suitable candidates for HIV vaccine trials.
Healthy, HIV-negative subjects will be recruited and screened. The results of this study will be used to determine if the subject meets eligibility requirements for participation in H1V vaccine trials. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
Subjects: Healthy adults
Number of Subjects: Approximately 3,000
Outline of Protocol: There are one or more visits to evaluate the subject for their eligibility for an HIV vaccine trial. The evaluation will usually include laboratory studies, physical assessment, and counseling on avoidance of HIV infection, pregnancy and other HIV-related issues. Only those evaluations needed to determine eligibility for a particular study will be done. Evaluations of blood and urine samples other than those described in this protocol may be done if necessary for eligibility for a study.
If it is determined that the subject might be eligible for an HIV vaccine trial, the subject will receive additional information about trial options by telephone, mail and/or visit with study coordinator. Several visits may occur if needed to confirm eligibility for participation in a vaccine clinical trial.
Study Duration: Varies from about 2 weeks to six months for each subject
Monitoring of Trial: Principal Investigator and designated staff of the Vaccine Research Center Regulatory, Affairs and Clinical Trials Core
Sponsoring Agency: Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), NIH
Clinical Sites: NIH Clinical Center [including satellite locations such as the VRC Mobile Clinical Trials Unit (MCTU) or the VRC Clinic at Cedar Lane] and IRB-approved extramural sites
Principal Investigator: Barney S. Graham, M.D., Ph.D., VRC/NIAID/NIH
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- INCLUSION CRITERIA:
Age: 18-60 years of age.
Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
Able and willing to complete the informed consent process.
Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.
EXCLUSION CRITERIA:
Known to be HIV infected.
Women who are known to be pregnant and/or breast feeding.
A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
研究計画
研究はどのように設計されていますか？
協力者と研究者
捜査官
- 主任研究者：Barney S Graham, M.D.、National Institute of Allergy and Infectious Diseases (NIAID)
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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