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

NCT01213810 | Withdrawn Phase 1 DMC

• 1 other identifier: SHCS 610
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Herpes Zoster

Keywords

HIV; VZV (Varicella zoster Virus); vaccine; T cell; immunogenicity; safety

Outcome Measures

Primary Outcomes (2)

• 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.

  half a year

• Safety

  Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

  half a year

Interventions

Zostavax BIOLOGICAL

Biological/Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Barbara Hasse, MD

  University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: October 4, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 1, 2013

Record last verified: 2013-02