A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants With Overall Good Health and Without HIV
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 20
- 主要终点
- Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In overall good health as determined by medical history, physical exam, and laboratory values
- •HIV uninfected
- •CMV seropositive
- •Willing to use condoms during intercourse for the duration of the study
- •Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
- •Childbearing status
- •Part A: Only participants of non-childbearing potential
- •Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study
排除标准
- •Participant is immunocompromised
- •Participant has an autoimmune disorder
- •Participants having intimate contact with immunocompromised individuals
- •Participants having intimate contact with a pregnant partner or partner planning to become pregnant
- •Participants who are breastfeeding
研究组 & 干预措施
VIR-1388, 5×10^4 ffu
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
干预措施: VIR-1388 (Biological)
VIR-1388, 5×10^5 ffu
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
干预措施: VIR-1388 (Biological)
VIR-1388, 5×10^6 ffu
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
干预措施: VIR-1388 (Biological)
Placebo
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)
时间窗: 12 months
Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Incidence of solicited local site and systemic reactogenicity events
时间窗: 14 days after administration of each dose
Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
次要结局
- Frequency of HIV-1 Mfuse1-specific CD4 T cells(12 months)
- Frequency of HIV-1 Mfuse1-specific CD8 T cells(12 months)
- Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells(12 months)
- Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells(12 months)
- Number of participants with VIR-1388 vector viremia in plasma(12 months)
- Number of participants with VIR-1388 vector shedding in saliva and urine(12 months)