Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
Фаза 1/2
Завершено
NCT03284710
| Заболевание | HIV Infections |
|---|
| Фаза | Фаза 1/2 |
|---|
| Спонсор | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|
| Статус | Завершено |
|---|
| Участники | 132 участн. |
|---|
| Вмешательство | ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension, Bivalent Subtype C gp120 |
|---|
| Дата начала | 19.06.2017 |
|---|
| Дата завершения | 12.12.2019 |
|---|
| Публикация результатов | 18.02.2021 |
|---|
Кратко
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 |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 26 Participants |
|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 27 Participants |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 27 Participants |
|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 29 Participants |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 27 Participants |
|---|
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 |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 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 |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 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 |
|---|
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 22000 relative fluorescence units |
|---|
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 |
|---|
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 27 Participants |
|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 12 Participants |
|---|
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 22 Participants |
|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 18 Participants |
|---|
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 27 Participants |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.