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

University of Zurich (UZH)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Herpes Zoster

Treatments

Biological: Zostavax

Study type

Interventional

Funder types

Other

Identifiers

NCT01213810

SHCS 610

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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