Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

Study Overview

• Status: Completed
• Conditions: AIDS
• Intervention / Treatment: Procedure: Blood collection; Biological: GSK HIV vaccine 732462

Detailed Description

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • GSK Investigational Site
  • Créteil, France, 94010
    • GSK Investigational Site
  • Nantes, France, 44093
    • GSK Investigational Site
  • Paris, France, 75018
    • GSK Investigational Site
  • Paris, France, 75679
    • GSK Investigational Site
  • Paris Cedex 10, France, 75475
    • GSK Investigational Site
  • Paris Cedex 12, France, 75571
    • GSK Investigational Site
  • Paris Cedex 13, France, 75651
    • GSK Investigational Site
  • Paris Cedex 20, France, 75970
    • GSK Investigational Site
  • Paris cedex 15, France, 75908
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20095
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • GSK Investigational Site
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80335
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80801
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81371
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • GSK Investigational Site
• Spain
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Móstoles, Madrid, Spain, 28935
    • GSK Investigational Site
  • Valencia, Spain, 46014
    • GSK Investigational Site
• United States
  • California
    • Bakersfield, California, United States, 93301
      • GSK Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • GSK Investigational Site
    • Orlando, Florida, United States, 32803
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • GSK Investigational Site
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
  • Virginia
    • Annandale, Virginia, United States, 22003
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

• HIV-infected subject.
• Previous participation in a study evaluating GSK HIV vaccine 732462.
• Written informed consent obtained from the subject.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Subjects who did not receive a complete vaccination course in previous studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study	Procedure: Blood collection; Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.; Biological: GSK HIV vaccine 732462; No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
Other: Group B; Subjects who were administered placebo in primary studies and who accepted to participate in this study	Procedure: Blood collection; Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)	Once a year after Visit 1 (during a maximum of 4 years)
CD4 count	Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of each separate defining condition for HIV-disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of potential immune-mediated diseases (pIMDs)	Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation	Once a year after Visit 1 (during a maximum of 4 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time between dose 1 and ART (re)-initiation or ART modification	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and CD4 count measurement	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and VL measurement	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and occurrence of HIV disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression	Once a year after Visit 1 (during a maximum of 4 years)
Antibody concentrations to vaccine antigens	Once a year after Visit 1 (during a maximum of 4 years)
Cell-mediated immunity responses	Once a year after Visit 1 (during a maximum of 4 years)
Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)	Once a year after Visit 1 (during a maximum of 4 years)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2010
• Primary Completion (Actual): March 17, 2014
• Study Completion (Actual): May 19, 2014

Study Registration Dates

• First Submitted: March 22, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: HIV therapeutic vaccine; long-term follow-up study; HIV-infected subjects
• Other Study ID Numbers: 114083; 2009-018097-64 (EudraCT Number)