Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
第1/2相
完了
NCT03284710
| 対象疾患 | HIV Infections |
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| 相 | 第1/2相 |
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| スポンサー | National Institute of Allergy and Infectious Diseases (NIAID) |
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| ステータス | 完了 |
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| 参加者数 | 132 名 |
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| 介入（薬剤） | 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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| 開始日 | 2017年6月19日 |
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| 完了日 | 2019年12月12日 |
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| 結果公開日 | 2021年2月18日 |
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概要
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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