PER-021-18招募中未知
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF V114 FOLLOWED BY ADMINISTRATION OF PNEUMOVAX™ 23 EIGHT WEEKS LATER IN ADULTS INFECTED WITH HIV (PNEU–WAY)
Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,0 个研究点目标入组 0 人开始时间: 2018年9月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
- •1.Women and men of at least 18 years of age
- •2.Infected with HIV and CD4+ T-cell count ≥50 cells/μL and plasma HIV RNA <50,000 copies/mL tested at Screening
- •3.Receiving combination ART for at least 6 weeks prior to study entry with no intended changes to combination ART therapy for 3 months after randomization.
- •4.If participant is female, she is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow the contraceptive guidance in protocol.
- •5.The participant provides written informed consent for the study.
排除标准
- •1.History of opportunistic infections 12 months before the first vaccination
- •2.History of non-infectious AIDS-related illness such as Kaposi´s sarcoma, wasting syndrome, or HIV-associated nephropathy.
- •3.History of active hepatitis with elevation in pretreatment ALT or AST values >5 times the upper limit of normal within 6 months before the first vaccination
- •4.History of IPD or known history of other culture-positive pneumococcal disease within 3 years of Visit 2
- •5.Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine or known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease.
- •6.Coagulation disorder contraindicating intramuscular vaccinations.
- •7.Recent febrile illness
- •8.History of malignancy ≤5 years prior to signing informed consent.
- •9.A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 2 or Is breastfeeding.
- •10.Prior administration of any pneumococcal vaccine or expected to receive any pneumococcal vaccine during the study outside of the protocol.
- •11.Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry.
- •12.Received any licensed, non-live vaccine within the 14 days before receipt of any study vaccine or any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any of the above within 30 days following receipt of any study vaccine.
- •13.Is participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
- •14.Has history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study.
研究者
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