PER-035-19招募中未知
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 EFFICACY STUDY OF AHETEROLOGOUS VACCINE REGIMEN OF AD26.MOS4.HIV AND ADJUVANTED CLADE C GP140 ANDMOSAIC GP140 TO PREVENT HIV-1 INFECTION AMONG CIS-GENDER MEN AND TRANSGENDERINDIVIDUALS WHO HAVE SEX WITH CIS-GENDER MEN AND/OR TRANSGENDER INDIVIDUALS.
Janssen Vaccines & Prevention B.V.,0 个研究点目标入组 1,620 人开始时间: 2020年1月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 1,620
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •- Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less anal sex within a mutually monogamous relationship >=12 months if the partner is HIV negative or living with HIV and virally suppressed) or rectal or urethral gonorrhea or chlamydia or incident syphilis or any stimulant use (example, cocaine, amphetamine) or 5 or more sex partners.
- •- Potential participant is negative for HIV-1 and HIV-2 infection less than (<) 28 days prior to first vaccination.
- •- Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening.
- •- Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable
- •methods of contraception for those participating in clinical studies.
- •- All participants of childbearing potential must have a negative highly sensitive urine or serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration.
排除标准
- •- Potential participants choosing to use PrEP. However, once participants received the first vaccination, they will be allowed to start PrEP while in the study according to the site PrEP
- •plan. The use of long acting PrEP is disallowed from 24 months prior to Day 1.
- •- Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who
- •received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.
- •- Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the
- •HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis
- •- Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines.
- •- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination.
研究者
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