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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165203
First received: July 15, 2010
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Biological: Herpes Zoster Vaccine 1437173A
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Serious adverse events (SAEs) [ Time Frame: From Month 0 to Month 18. ] [ Designated as safety issue: No ]
  • Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine [ Time Frame: from screening (up to 21 days prior to Month 0) until Month 18. ] [ Designated as safety issue: No ]
  • Occurrence of any fatal SAEs [ Time Frame: from screening (up to 21 days prior to Month 0) until Month 18. ] [ Designated as safety issue: No ]
  • Occurrence of pre-defined adverse events (AEs) [ Time Frame: From Month 0 until Month 18. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs [ Time Frame: Within 30 days (Days 0-29) after each vaccination. ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Screening Visit (up to 21 days prior to Month 0). ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Month 1. ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Month 2. ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Month 3. ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Month 6. ] [ Designated as safety issue: No ]
  • Hematological and biochemical parameters [ Time Frame: At Month 7. ] [ Designated as safety issue: No ]
  • Worsening of the human immunodeficiency virus (HIV) condition: significant change in Antiretroviral Therapy (ART), including initiation of ART in ART-naïve subjects [ Time Frame: From Month 0 until Month 18. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: occurrence of an AIDS-defining condition [ Time Frame: From Month 0 until Month 18. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV viral load (VL) and CD4 T cell count [ Time Frame: At Month 1. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV VL [ Time Frame: At Month 3. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV VL [ Time Frame: At Month 7. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV CD4 T cell count [ Time Frame: At Month 1. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV CD4 T cell count [ Time Frame: At Month 2. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV CD4 T cell count [ Time Frame: At Month 3. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV CD4 T cell count [ Time Frame: At Month 6. ] [ Designated as safety issue: No ]
  • Worsening of the HIV condition: pre-defined changes in HIV CD4 T cell count [ Time Frame: At Month 7. ] [ Designated as safety issue: No ]
  • Cell-mediated immunogenicity (CMI) in a subset of subjects [ Time Frame: At Month 7. ] [ Designated as safety issue: No ]
  • Humoral immune response in a subset of subjects [ Time Frame: At Month 7. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell-mediated immunogenicity [ Time Frame: At Months 0, 1, 2, 3, 6, 7 and 18. ] [ Designated as safety issue: No ]
  • Humoral immune response [ Time Frame: At Months 0, 1, 2, 3, 6, 7 and 18. ] [ Designated as safety issue: No ]
  • Occurrence, duration and severity of HZ cases and complications [ Time Frame: From Month 0 until Month 18. ] [ Designated as safety issue: No ]
  • CD4 count and HIV VL [ Time Frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18. ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: Herpes Zoster Vaccine 1437173A
intramuscular injection
Placebo Comparator: Group B
Not Applicable
Biological: Placebo
intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of Varicella Zoster virus (VZV) infection or serological evidence of prior VZV infection;
  • Written informed consent obtained from the subject;
  • Female subjects of non-childbearing potential may be enrolled in the study; Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;

  • Known to be human immunodeficiency virus-1 (HIV-1) infected, diagnosed at least 1 year prior to enrolment;
  • For the antiretroviral therapyART High CD4 and ART Low CD4 cohorts:

    • Stable on ART for at least one year
    • CD4 T cell count >= 50 cells /mm3 at screening
    • Undetectable VL at screening;
  • For the non-ART High CD4 cohort:

    • ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis and for whom commencement of ART is not expected based on current assessment within next seven months;
    • HIV VL >= 1000 copies/mL and <= 100 000 copies/mL at screening
    • CD4 T cell count >= 500 cells/mm3 at screening.

Exclusion Criteria:

  • 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;
  • Occurrence of a varicella or HZ episode within the previous 12 months;
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. Please note, the vaccine and vials in this study do not contain latex;
  • Has currently an Acquired Immunodeficiency Syndrome (AIDS) defining condition;
  • Opportunistic infection or AIDS-associated malignancy in the previous year;
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection or immunosuppressive/cytotoxic therapy;
  • Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period;
  • Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose;
  • Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine;
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
  • Acute disease at the time of enrolment;
  • Any contraindication to receiving intramuscular injections;
  • Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine;
  • Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection.
  • Current use of HIV fusion inhibitors, chemokine (C-C motif) receptor (CCR5) inhibitors or Interleukin-2/ Interleukin-7/ Interferon;
  • For subjects in the ART cohorts, any change in anti-retroviral drug regimen within 12 weeks prior to vaccination;
  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue contraceptive precautions;
  • Abnormal biochemical and hematological laboratory values obtained for blood samples collected at screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165203

Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32803
United States, New Mexico
GSK Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
Germany
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40237
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20146
United Kingdom
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165203     History of Changes
Other Study ID Numbers: 112673
Study First Received: July 15, 2010
Last Updated: October 10, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
immunogenicity
vaccine
safety
HIV
Herpes Zoster

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Herpes Zoster
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 14, 2014