Clinical trial NCT03368053: Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Official title: Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
HIV Infections
Keywords: gp120
HIV infections
RV144
gp120-NefTat/AS01B vaccine candidate
V1V2
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University Ghent
First posted: 2017-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Descriptive mono-centric study with one single group.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call
timeFrame: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Anti-V1V2 Total IgG Antibody BAMA Response Magnitude
timeFrame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call
timeFrame: At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14
measure: Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude
timeFrame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
Secondary outcomes:
measure: Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call
timeFrame: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Anti-gp 120 Total IgG Antibody BAMA Response Magnitude
timeFrame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel
timeFrame: At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel
timeFrame: At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers
timeFrame: At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers
timeFrame: At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
timeFrame: At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14
measure: Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers
timeFrame: At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van Der Meeren O, Jongert E, Seaton KE, Koutsoukos M, Aerssens A, Brackett C, Debois M, Janssens M, Leroux-Roels G, Mesia Vela D, Sawant S, Yates NL, Tomaras GD, Leroux-Roels I, Roman F. Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01B vaccination. Vaccine. 2020 Feb 11;38(7):1678-1689. doi: 10.1016/j.vaccine.2019.12.058. Epub 2020 Jan 10.