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

Herpes Zoster Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01213810
• Other study ID #: SHCS 610
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 13, 2010
• Last updated: February 28, 2013
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Zostavax
Biological/Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety	Number of Participants with Adverse Events as a Measure of Safety and Tolerability"	half a year	Yes