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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01092611
First received: March 22, 2010
Last updated: August 14, 2014
Last verified: August 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 ]

Enrollment: 190
Study Start Date: March 2010
Study Completion Date: May 2014
Primary Completion Date: May 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 subject and 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 14, 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 September 22, 2014