EUCTR2018-003666-13-ES进行中（未招募）1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals who Have Sex with Cis-gender Men and/or Transgender Individuals - MOSAICO
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Potential participant is =18 to =60 years old on the day of signing the ICF.
- •? 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 (transgender man having sex exclusively with transgender men is excluded), OR
- •- Gender non-conforming individual having receptive anal and/or vaginal condomless 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 condomless receptive anal or vaginal sex (not included is condomless 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 (eg, cocaine, amphetamine), OR
- •- 5 or more sex partners
- •? Potential participant is negative for HIV-1 and HIV-2 infection <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 ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening
- •- Have a negative urine ß-hCG pregnancy test immediately prior to each study vaccine administration
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Potential participant shares needles during injection of drugs or any other substance.
- •? Potential participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
- •? Potential participant received or plans to receive:
- •- licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]
- •- other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccination[s].
- •? 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 has used investigational research agents within 28 days of randomization.
- •? 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 been in receipt of blood or Ig products in the past 3 months.
- •? Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines.
- •? Potential participant has a history of any chronic/recurrent conditions that require regular/recurrent use of oral/parenteral corticosteroids or other immunomodulators/immunosuppressors. Ocular, topical or inhaled steroids are allowed.
- •? 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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