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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01092611
First received: March 22, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
AIDS
Procedure: Blood collection
Biological: GSK HIV vaccine 732462
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • CD4 count [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Viral load (VL) and method of measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of HIV disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of each separate defining condition for HIV-disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of specific clinical events and death [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of potential immune-mediated diseases (pIMDs) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of SAEs related to study participation [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time between dose 1 and ART (re)-initiation or ART modification [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and CD4 count measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and VL measurement [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and occurrence of HIV disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Antibody concentrations to vaccine antigens [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Cell-mediated immunity responses [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]
  • Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays) [ Time Frame: Once a year after Visit 1 (during a maximum of 4 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 213
Study Start Date: March 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092611

  Show 41 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01092611     History of Changes
Other Study ID Numbers: 114083, 2009-018097-64
Study First Received: March 22, 2010
Last Updated: April 10, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
long-term follow-up study
HIV-infected subjects
HIV therapeutic vaccine

ClinicalTrials.gov processed this record on April 16, 2014