recombinant varicella zoster virus glycoprotein E for Herpes zoster

Inclusion criteria

• {"criterion_text":"- Male and female adults between 50 and 65 years of age"}
• {"criterion_text":"- Be healthy"}
• {"criterion_text":"- Willingness to sign the consent form"}
• {"criterion_text":"- Willingness to the 9 blood samples"}
• {"criterion_text":"- Willingness to receive the 2 doses of the RHZ vaccine (at 2-6 months interval)"}

Exclusion criteria

• {"criterion_text":"- Intake of any immunosuppressive therapies"}
• {"criterion_text":"- Contraindication for the RHZ vaccine or one or more of the constituents"}
• {"criterion_text":"- Pre-menoposal women"}
• {"criterion_text":"- Any form of immunosuppression"}
• {"criterion_text":"- Recent live or non-live vaccination(s) (3 months prior to inclusion)"}
• {"criterion_text":"- Unwillingness to sign the consent form"}
• {"criterion_text":"- Prior varicella zoster virus vaccination"}
• {"criterion_text":"- Prior herpes zoster virus vaccination"}
• {"criterion_text":"- History of prior episode of herpes zoster"}
• {"criterion_text":"- Active herpes zoster at day 0 of the study"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study will be the variations and evolution of quantitative values of the 3 parameters over the 3 weeks study period: VZV-specific CMI and quantification, VZV-specific HMI and quantification and Lymphocyte typing","definition_or_measurement_approach":"Quantitative values of VZV-specific cell-mediated immunity (CMI), VZV-specific humoral immunity (HMI) and lymphocyte typing measured by blood tests over the 3-week study period (measurements before and after vaccination)."}

Belgium

Earliest CTIS Part Ii Submission Date

17-11-2025

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

17

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Centre hospitalier universitaire de Liege

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium