Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
研究概览
简要总结
The purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461) vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation (CD4+) T cell and CD8+ T cell responses will also be evaluated.
详细描述
GlaxoSmithKline (GSK) contributes to the public-private pox-protein partnership (P5) which is currently assessing the safety, immunogenicity and clinical efficacy of a prime-boost regimen aimed at preventing HIV transmission (http://www.hvtn.org/en.html). The booster component of the candidate vaccine used in this program consists of two gp120 clade C proteins administered with an adjuvant. In order to inform the selection of the adjuvant in future studies, data on long-term persistence of immunity after vaccination with gp120/AS01 would prove useful. The present study was designed to address this question using a cohort of volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •A subject who has received at least 3 doses of the gp120-NefTat/AS01B (GSKSB732461) vaccine candidate in GSK Biologicals-sponsored PRO HIV-002 study.
排除标准
- •Use of any investigational or non-registered product during 30 days prior to study enrolment.
- •History of HIV-1 or HIV-2 infection.
- •Participation to another clinical trial of an investigational HIV vaccine between study PRO HIV-002 and the present study.
- •Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting one month preceding this study. For corticosteroids, this will mean prednisone higher than or equal to (≥) 20 mg/day . Inhaled and topical steroids are allowed.
- •Administration of cytotoxic medication within 6 months preceding this study.
- •History of daily, long-term immunosuppressive medication between study PRO HIV-002 and the present study.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before enrolment.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition other than HIV disease, based on medical history and physical examination between study PRO HIV-002 and the present study.
- •Past administration of an investigational vaccine containing AS01 other than the gp120-NefTat/AS01B (GSKSB732461) vaccine administered in PRO HIV-002 study.
结局指标
主要结局
Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
时间窗: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". The C.1086C_V1_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
时间窗: At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C_V1_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
时间窗: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
To comply with BAMA methodology and terminology, the wording "BAMA response call status" was used instead of "seropositivity" in the analysis. Compared to baseline result (Day 0), a sample is called "positive" for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The C.1086C_V1_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
时间窗: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
Whenever results were provided as "Mean Fluorescence Intensity (MFI)", the statistical outputs "BAMA response magnitude (MFI)" terminology is used instead of "concentrations/titres". Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C_V1_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed.
次要结局
- Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call(At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel(At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers(At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers(At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Anti-gp 120 Total IgG Antibody BAMA Response Magnitude(At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers(At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers(At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14)
- Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel(At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14)