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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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01213810
First received: August 13, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Herpes Zoster
 Biological: Zostavax
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: half a year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability"


Enrollment: 0
Study Start Date: December 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Zostavax
    Biological/Vaccine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213810

Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Barbara Hasse, MD University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01213810     History of Changes
Other Study ID Numbers: SHCS 610
Study First Received: August 13, 2010
Last Updated: February 28, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
HIV
VZV (Varicella zoster Virus)
vaccine
 T cell
immunogenicity
safety

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013