A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants *Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Frequency of serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.
详细描述
This study will evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.
Participants will be randomly assigned to one of five groups. Participants in all five groups will receive GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Then, at Months 4, 6, and 10, participants will receive three additional injections according to their assigned group:
- Group 1: MVA/HIV62B, placebo for B63521^11 gp120, and placebo for IHV01, all by IM injection
- Group 2: MVA/HIV62B by IM injection and placebo for B63521^11 gp120 and for IHV01, both by subcutaneous (SC) injection
- Group 3: MVA/HIV62B, B63521^11 gp120, and IHV01, all by IM injection
- Group 4: MVA/HIV62B, placebo for B63521^11 gp120, and IHV01, all by IM injection
- Group 5: MVA/HIV62B by IM injection and IHV01 and B63521^11 gp120, both by SC injection
Participants will attend several study visits through Month 16. Visits may include physical examinations, blood and urine collection, electrocardiogram, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 24 for follow-up health monitoring.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Frequency of serious adverse events
时间窗: Measured through Month 16
Summarized using MedDRA System Organ Class and preferred terms
HIV-specific IgG binding breadth to cross-clade panels of gp120 and V1V2, and gp41
时间窗: Measured through Month 10.5
As assessed by BAMA
Frequency of systemic reactogenicity signs and symptoms
时间窗: Measured through Month 10
Systemic symptoms include increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, and nausea.
HIV-specific IgG binding magnitude to cross-clade panels of gp120 and V1V2, and gp41
时间窗: Measured through Month 10.5
As assessed by binding antibody multiplex assay (BAMA)
Response rate of CD4+ T-cell responses to Env
时间窗: Measured through Month 10.5
As assessed by intracellular cytokine staining (ICS)
HIV-specific IgG binding response rate to cross-clade panels of gp120 and V1V2, and gp41
时间窗: Measured through Month 10.5
As assessed by BAMA
Magnitude of CD4+ T-cell responses to Env
时间窗: Measured through Month 10.5
As assessed by ICS
Frequency of local reactogenicity signs and symptoms
时间窗: Measured through Month 10
Local symptoms include pain and/or tenderness at the injection site.
Frequency of adverse events
时间窗: Measured through Month 16
Summarized using Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and preferred terms
次要结局
- IgA responses to gp120 and gp41(Measured through Month 16)
- IgG avidity to defined epitope specificities(Measured through Month 10.5)
- HIV-specific IgG binding magnitude to gp120, V1V2, and gp41(Measured through Month 16)
- Response rate of antibody-dependent cellular cytotoxicity (ADCC)-mediating antibody responses(Measured through Month 16)
- IgA responses to gp120, V1V2, and gp41(Measured through Month 10.5)
- IgG3 responses to gp120, V1V2, and gp41(Measured through Month 10.5)
- HIV-specific IgG binding magnitude to V3, CD4i and gp41 IDR(Measured through Month 10.5)
- HIV-specific IgG binding response rate to V3, CD4i and gp41 IDR(Measured through Month 10.5)
- HIV-specific IgG binding response rate to gp120, V1V2, and gp41(Measured through Month 16)
- Magnitude of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses(Measured through Month 16)
- IgG3 responses to gp120 and gp41(Measured through Month 16)
- Magnitude of ADCC-mediating antibody responses(Measured through Month 16)
- Response rate of vaccine-elicited antibody binding to FcƴR proteins(Measured through Month 16)
- Magnitude of vaccine-elicited antibody binding to FcƴR proteins(Measured through Month 16)
- Response rate of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses(Measured through Month 16)