search
Back to results

Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study

Primary Purpose

Herpes Zoster

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Zostavax
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring HIV, VZV (Varicella zoster Virus), vaccine, T cell, immunogenicity, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: All individuals

  • Age >18 years
  • Male, or female with negative urine pregnancy test
  • VZV-seropositive (serologically documented)
  • Agree to use a barrier method of birth control (such as a condom)
  • Written informed consent HIV positive individuals on ART (group A1-A3)
  • Continuous ART for >3 months before baseline
  • No change of ART regimen within 1 month before baseline
  • HIV-RNA (value must be <3 months old )<50 copies/ml at last visit
  • CD4-count (value must be <3 months old) > 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3
  • Participation in the SHCS HIV-positive individuals without ART (group B)
  • HIV-1 RNA >1000 copies/ml (<3 months before baseline)
  • CD4-cell count >500 cells/µl (<3 months before baseline)
  • Participation in the SHCS Healthy HIV-negative volunteers (group C)
  • Negative HIV-screening test (<3 months before baseline)
  • CD4 cell count >500 cells/µl

Exclusion criteria: Common exclusion criteria

  • Contraindications on ethical grounds
  • Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
  • Pregnancy or breast feeding.
  • Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
  • Known or suspected non-compliance, drug- or alcohol abuse.

Specific exclusion criteria

  • Fever > 38.3 °C or acute illness during the last 4 weeks
  • Exposure to chickenpox or shingles within four weeks prior to study entry
  • History of shingles
  • Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids)
  • Household contact with known immunodeficiency (e.g. HIV-positive with CD4 <250 cells/µl)
  • Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination
  • Previous allergic reaction to vaccine components (i.e. neomycin or gelatin)
  • Vaccination with a life attenuated vaccine one month prior to study entry
  • History of chickenpox vaccination
  • Treatment with anti-herpes drugs 4 weeks before baseline
  • Severe coagulation disorder or oral anticoagulant treatment

  • Laboratory exclusion criteria.

    • Thrombocytopenia < 50x 103/?l
    • Haemoglobin <12 g/dl
    • More than threefold elevation of ALT
    • Creatinine of more than150 µmol/l
    • Glucose >10 mmol/l

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Immunogenicity
    Geometric mean titer of Varicella zoster virus-specific IgG, VZV-specific T- cells per 106 peripheral mononuclear cells, Frequency of VZV-specific T- cells of total T-cells, CD4+ T-cells in different HIV-positive persons.
    Safety
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2010
    Last Updated
    February 28, 2013
    Sponsor
    University of Zurich
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01213810
    Brief Title
    Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2011 (Anticipated)
    Study Completion Date
    June 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status. Trial with medicinal product Trial with immunomodulatory product / biological

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster
    Keywords
    HIV, VZV (Varicella zoster Virus), vaccine, T cell, immunogenicity, safety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Zostavax
    Intervention Description
    Biological/Vaccine
    Primary Outcome Measure Information:
    Title
    Immunogenicity
    Description
    Geometric mean titer of Varicella zoster virus-specific IgG, VZV-specific T- cells per 106 peripheral mononuclear cells, Frequency of VZV-specific T- cells of total T-cells, CD4+ T-cells in different HIV-positive persons.
    Time Frame
    half a year
    Title
    Safety
    Description
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
    Time Frame
    half a year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: All individuals Age >18 years Male, or female with negative urine pregnancy test VZV-seropositive (serologically documented) Agree to use a barrier method of birth control (such as a condom) Written informed consent HIV positive individuals on ART (group A1-A3) Continuous ART for >3 months before baseline No change of ART regimen within 1 month before baseline HIV-RNA (value must be <3 months old )<50 copies/ml at last visit CD4-count (value must be <3 months old) > 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3 Participation in the SHCS HIV-positive individuals without ART (group B) HIV-1 RNA >1000 copies/ml (<3 months before baseline) CD4-cell count >500 cells/µl (<3 months before baseline) Participation in the SHCS Healthy HIV-negative volunteers (group C) Negative HIV-screening test (<3 months before baseline) CD4 cell count >500 cells/µl Exclusion criteria: Common exclusion criteria Contraindications on ethical grounds Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study). Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject. Pregnancy or breast feeding. Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc), Known or suspected non-compliance, drug- or alcohol abuse. Specific exclusion criteria Fever > 38.3 °C or acute illness during the last 4 weeks Exposure to chickenpox or shingles within four weeks prior to study entry History of shingles Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids) Household contact with known immunodeficiency (e.g. HIV-positive with CD4 <250 cells/µl) Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination Previous allergic reaction to vaccine components (i.e. neomycin or gelatin) Vaccination with a life attenuated vaccine one month prior to study entry History of chickenpox vaccination Treatment with anti-herpes drugs 4 weeks before baseline Severe coagulation disorder or oral anticoagulant treatment Laboratory exclusion criteria. Thrombocytopenia < 50x 103/?l Haemoglobin <12 g/dl More than threefold elevation of ALT Creatinine of more than150 µmol/l Glucose >10 mmol/l
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara Hasse, MD
    Organizational Affiliation
    University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study

    We'll reach out to this number within 24 hrs