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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01213810

Enrollment

Registered

2010-10-04

Start date

2010-12-31

Completion date

2012-06-30

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Keywords

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

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

Interventions

BIOLOGICALZostavax

Biological/Vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Immunogenicity	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	half a year	Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026