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
|ClinicalTrials.gov Identifier: NCT01213810|
Recruitment Status : Withdrawn
First Posted : October 4, 2010
Last Update Posted : March 1, 2013
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 or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: Zostavax||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||June 2012|
- Biological: Zostavax
- 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"
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213810
|Principal Investigator:||Barbara Hasse, MD||University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology|