PER-060-07未知未知
A Phase IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons
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研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Men or women, ≥18 and ≤45 years of age who, within the 24-week period prior to randomization, and met one or more of the risk criteria for HIV infection.
- •2. Ability and willingness to grant informed consent and to be available for follow-up for the duration of the study.
- •3. Willingness to undergo HIV testing, counseling about HIV and receiving the results of HIV tests.
- •4. If a woman of childbearing age agrees to use a contraceptive method from a minimum of 3 weeks before randomization until at least 4 weeks after receiving the last injection of the study and undergo pregnancy tests as specified in the schedule of the protocol.
- •5. Persons not infected with HIV.
- •6. Negative result in a pregnancy test of a woman of childbearing age carried out within 24 hours prior to randomization.
排除标准
- •1. Women who are breastfeeding a baby under 24 weeks of age or who plan to become pregnant during the period that begins at randomization and ends 4 weeks after receiving the last injection of the study.
- •2. Participation in a clinical trial of another experimental product in the previous 12 weeks.
- •3. Contraindicated intramuscular injections, history of bleeding disorders or treatment with anticoagulants during the 4 weeks prior to randomization.
- •4. Have previously received an experimental vaccine against HIV.
- •5. History of severe systemic or local reactogenicity to vaccines or severe allergic reactions or recurrent urticaria of unknown origin in the last 5 years.
- •6. Have received an inactivated vaccine in the previous 2 weeks.
- •7. Have received any blood product or any immunomodulator in the previous 12 weeks.
- •8. History of malignant tumors.
- •9. History of a clinically significant autoimmune disease or of an immunodeficiency syndrome at any time or the use of immunosuppressants in the previous 24 weeks.
- •10. Other seizure disorder other than: A) Febrile convulsions in children under two years of age. B) Seizures secondary to alcohol withdrawal more than 3 years ago. C) A single seizure more than 3 years ago that has not been repeated or needed treatment in the last 3 years.
- •11. Any disease that would alter the performance of the study or, together with participation in the study, would endanger the health of the subject.
- •12. Any acute illness that must be evaluated, treated and resolved before the randomization of the study.
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