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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213810
Recruitment Status : Withdrawn
First Posted : October 4, 2010
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
University of Zurich

August 13, 2010
October 4, 2010
March 1, 2013
December 2010
December 2011   (Final data collection date for primary outcome measure)
  • Immunogenicity [ Time Frame: half a year ]
    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 [ Time Frame: half a year ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Same as current
Complete list of historical versions of study NCT01213810 on Archive Site
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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
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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
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Herpes Zoster
Biological: Zostavax
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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SHCS 610
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University of Zurich
University of Zurich
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Principal Investigator: Barbara Hasse, MD University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
University of Zurich
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP