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
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Clinicaltrials.gov ID
NCT01092611
EudraCT ID
2009-018097-64
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2014-17-03
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
Completed
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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