Last updated: 11/07/2018 07:10:56

Long-term follow-up of participants from studies evaluating GSK HIV vaccine

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GSK study ID
114083
See study documents
Clinicaltrials.gov ID
NCT01092611
EudraCT ID
2009-018097-64
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long-term follow-up of participants from studies evaluating the HIV vaccine 732462
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

CD4 count

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Viral load (VL) and method of measurement

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Occurrence of HIV disease progression

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Occurrence of each separate defining condition for HIV-disease progression

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Occurrence of specific clinical events and death

Timeframe: 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)

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Occurrence of potential immune-mediated diseases (pIMDs)

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Occurrence of SAEs related to study participation

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Secondary outcomes:

Time between dose 1 and ART (re)-initiation or ART modification

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Time between dose 1 and CD4 count measurement

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Time between dose 1 and VL measurement

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Time between dose 1 and occurrence of HIV disease progression

Timeframe: 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

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Antibody concentrations to vaccine antigens

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Cell-mediated immunity responses

Timeframe: 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)

Timeframe: Once a year after Visit 1 (during a maximum of 4 years)

Interventions:
  • Procedure/surgery: Blood collection
  • Biological/vaccine: GSK HIV vaccine 732462
    • Enrollment:
    190
    Primary completion date:
    2014-17-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Harrer T et al. (2018) Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 36(19):2683-2686.
    Medical condition
    AIDS
    Product
    SB732462
    Collaborators
    Not applicable
    Study date(s)
    March 2010 to May 2014
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • All subjects must satisfy ALL the following criteria at study entry:
    • HIV-infected subject.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Annandale, Virginia, United States, 22003
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paris Cedex 13, France, 75651
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Madrid, Spain, 28041
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32803
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80801
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paris, France, 75018
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 41 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2014-17-03
    Actual study completion date
    2014-19-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 114083 can be found on the GSK Clinical Study Register
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