Phase 1 N=36 Basic Science

Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)

Infection, Human Immunodeficiency Virus · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT03368053 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call — 25; 15; 8; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Blood sampling (Procedure)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call	25; 15; 8; 20; 12; 9	—
PRIMARY Anti-V1V2 Total IgG Antibody BAMA Response Magnitude	1.3; 5444.9; 147.5; 29.5; 1.4; 1272.5	—
PRIMARY Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call	2; 0; 0; 2; 1; 0	—
PRIMARY Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude	1.7; 2.6; 1.5; 1.4; 1.5; 4.6	—
SECONDARY Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call	29; 29; 27; 25; 18; 6	—
SECONDARY Anti-gp 120 Total IgG Antibody BAMA Response Magnitude	2.5; 6796.7; 1633.3; 479.6; 1.0; 993.7	—
SECONDARY Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel	28; 27; 23; 28; 22; 11	—
SECONDARY Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel	1.0; 10365.4; 2834.1; 371.0; 1.0; 4396.8	—
SECONDARY Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers	0.00; 0.42; 0.32; 0.21	—
SECONDARY Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers	25; 23; 22	—
SECONDARY Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers	0.00; 0.00; 0.00; 0.00	—
SECONDARY Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers	0; 0; 0	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03368053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.