Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
1/2期
已完成
NCT03284710
| 适应症 | HIV Infections |
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| 分期 | 1/2期 |
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| 申办方 | National Institute of Allergy and Infectious Diseases (NIAID) |
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| 状态 | 已完成 |
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| 受试者人数 | 132 人 |
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| 干预（药物） | ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension, Bivalent Subtype C gp120 |
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| 开始日期 | 2017年6月19日 |
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| 完成日期 | 2019年12月12日 |
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| 结果公布日 | 2021年2月18日 |
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摘要
The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Measured at Month 6.5 · Participants
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 29 Participants |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 26 Participants |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 27 Participants |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 27 Participants |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 29 Participants |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 27 Participants |
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Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Measured at Month 6.5 · relative fluorescence units
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 22000 relative fluorescence units |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 relative fluorescence units |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 22000 relative fluorescence units |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 relative fluorescence units |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 22000 relative fluorescence units |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 relative fluorescence units |
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Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
Measured at Month 6.5 · Participants
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 22 Participants |
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| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 27 Participants |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 12 Participants |
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| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 22 Participants |
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| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 18 Participants |
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| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 27 Participants |
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