Last updated: 11/07/2018 04:57:21

Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects

GSK study ID
112673
Clinicaltrials.gov ID
EudraCT ID
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: Safety and immunogenicity of GlaxoSmithKline Biologicals’ herpes zoster vaccine 1437173A in adult HIV-infected subjects
Trial description: This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.
This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 18

Number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine

Timeframe: From screening (up to 21 days prior to Month 0) until Month 18

Number of subjects with any fatal SAEs

Timeframe: From screening (up to 21 days prior to Month 0) until Month 18

Number of subjects with any adverse events (AEs) of specific interest

Timeframe: From Month 0 until Month 18

Number of subjects with any, Grade 3 and related solicited local symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with unsolicited AEs

Timeframe: Within 30 days (Days 0-29) after each vaccination

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Screening Visit (up to 21 days prior to Month 0)

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Month 1

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Month 2

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Month 3

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Month 6

Number of subjects with any hematological and biochemical parameters below, within or above normal laboratory ranges

Timeframe: At Month 7

Number of subjects with any significant change in Antiretroviral Therapy (ART), including initiation of ART in ART-naïve subjects

Timeframe: From Month 0 until Month 18

Number of subjects with any AIDS-defining condition

Timeframe: From Month 0 until Month 18

Number of subjects with any pre-defined changes in HIV viral load (VL) and CD4 T-cell count

Timeframe: From Month 1 to Month 7

Number of subjects with any significant change in Antiretroviral Therapy (ART), including initiation of ART in ART-naïve subjects, by HIV status

Timeframe: From Month 0 to Month 18

Number of subjects with any AIDS-defining condition, by HIV status

Timeframe: From Month 0 to Month 18

Number of subjects with any pre-defined changes in HIV viral load (VL) and CD4 T-cell count, by HIV status

Timeframe: From Month 1 to Month 7

Frequency of gE-specific CD4 T-cells

Timeframe: At Month 7

­Anti-gE antibody (Ab) concentrations

Timeframe: At Month 7

Secondary outcomes:

­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells

Timeframe: At Month 0, 1, 2, 3, 6, 7 and 18

­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV status

Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18

­Anti-VZV and anti-gE Antibody concentrations

Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18

­Anti-VZV and anti-gE Antibody concentrations, by HIV status

Timeframe: At Months 0, 1, 2, 3, 6, 7 and 18

Number of subjects with any Herpes Zoster (HZ) cases and complications

Timeframe: From Month 0 until Month 18

CD4 count

Timeframe: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18

HIV VL

Timeframe: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18

Interventions:
  • Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
  • Biological/vaccine: Placebo
  • Enrollment:
    123
    Primary completion date:
    2012-06-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Berkowitz EM et al. (2015) Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 211(8):1279-1287.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to May 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
    • Male and female subjects at least 18 years old at the time of vaccination;
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
    • Vaccination against varicella or herpes zoster (HZ) within the previous 12 months;

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Woolwich, London, London, United Kingdom, SE18 4QH
    Status
    Study Complete
    Location
    GSK Investigational Site
    London, United Kingdom, SW10 9TH
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    Status
    Study Complete
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90813
    Status
    Study Complete
    Location
    GSK Investigational Site
    London, United Kingdom, NW3 2QG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 20146
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-06-07
    Actual study completion date
    2013-14-05

    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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