CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Blood samplingprocedure
Likely dose
Not stated in record
Key inclusion· 2
  • Previously received at least 3 doses of gp120-NefTat/AS01B (GSKSB732461) vaccine in GSK Biologicals-sponsored PRO HIV-002 study
  • Able and willing to comply with protocol requirements
Key exclusion· 8
  • History of HIV-1 or HIV-2 infection
  • Any investigational or non-registered product within 30 days prior to study enrollment
  • Participation in another investigational HIV vaccine trial between PRO HIV-002 and present study
  • Chronic immunosuppressants (prednisone ≥20 mg/day) or immune-modifying drugs in the month before study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03368053
NCT03368053Phase 1Completed

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

GlaxoSmithKline·interventional·Posted Dec 11, 2017·Updated Oct 20, 2020

In Brief

A Phase 1 clinical trial evaluating Blood sampling for Infection, Human Immunodeficiency Virus and HIV Infections. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
CollaboratorsUniversity Ghent

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2017
Enrollment StartDec 14, 2017
Primary CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago

Interventions

Blood samplingprocedure

Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.