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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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014