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