Clinical trial NCT01213810: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Herpes Zoster
Keywords: HIV
VZV (Varicella zoster Virus)
vaccine
T cell
immunogenicity
safety
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity
timeFrame: half a year
measure: Safety
timeFrame: half a year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
name: Barbara Hasse, MD
role: PRINCIPAL_INVESTIGATOR
References: