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
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|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Recruitment Status : Withdrawn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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|