Overview
Sponsor-declared trial summary
Herpes Zoster virus prevention
To investigate the sequential VZV-specific CMI and HMI as well as the lymphocyte typing before and after recombinant HZ vaccination, to better understand the post-vaccination transient specific VZV immunosuppression.
Key facts
- Sponsor
- Centre hospitalier universitaire de Liege
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2025-12-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To investigate the sequential VZV-specific CMI and HMI as well as the lymphocyte typing before and after recombinant HZ vaccination, to better understand the post-vaccination transient specific VZV immunosuppression.
Conditions and MedDRA coding
Herpes Zoster virus prevention
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male and female adults between 50 and 65 years of age
- Be healthy
- Willingness to sign the consent form
- Willingness to the 9 blood samples
- Willingness to receive the 2 doses of the RHZ vaccine (at 2-6 months interval)
Exclusion criteria 10
- Intake of any immunosuppressive therapies
- Pre-menoposal women
- Any form of immunosuppression
- Recent live or non-live vaccination(s) (3 months prior to inclusion)
- Unwillingness to sign the consent form
- Prior varicella zoster virus vaccination
- Prior herpes zoster virus vaccination
- History of prior episode of herpes zoster
- Active herpes zoster at day 0 of the study
- Contraindication for the RHZ vaccine or one or more of the constituents
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5984057 · Product
- Active substance
- Recombinant Varicella Zoster Virus Glycoprotein E
- Substance synonyms
- GSK-1437173A, RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BK03 — -
- Marketing authorisation
- EU/1/18/1272/001
- MA holder
- GLAXOSMITHKLINE BIOLOGICALS S.A.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre hospitalier universitaire de Liege
- Sponsor organisation
- Centre hospitalier universitaire de Liege
- Address
- Avenue De L'Hopital 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Centre hospitalier universitaire de Liege
- Contact name
- Arjen Nikkels
Public contact point
- Organisation
- Centre hospitalier universitaire de Liege
- Contact name
- Arjen Nikkels
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521547-20-00 | 2.1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Shingrix | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AL 2025-521547-20-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN 2025-521547-20-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2025-521547-20-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2025-521547-20-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-23 | Belgium | Acceptable 2025-12-04
|
2025-12-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-05 | Belgium | Acceptable 2025-12-04
|
2026-01-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-16 | Belgium | Acceptable 2025-12-04
|
2026-03-16 |