Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
40
Countries
1
Sites
1
Measles, mumps, and rubella
We will test in a randomized cross-over design in human volunteers, whether epicutaneous vaccination (EV) with the live attenuated Measles, Mumps, and Rubella (MMR) vaccine generates appropriate mucosal measles IgA response 3 months after receiving intervention
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune System Phenomena [G13], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 24 Nov 2024 → 30 Sep 2025
- Decision date (initial)
- 2023-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Independent Research Fund Denmark
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Prophylaxis, Efficacy
We will test in a randomized cross-over design in human volunteers,
whether epicutaneous vaccination (EV) with the live attenuated Measles,
Mumps, and Rubella (MMR) vaccine generates appropriate mucosal
measles IgA response 3 months after receiving intervention
Secondary objectives 1
- We will test in a randomized cross-over design in human volunteers, whether epicutaneous vaccination (EV) with the live attenuated Measles, Mumps, and Rubella (MMR) vaccine generates appropriate systemic and respiratory (mucosal) immune responses using outcomes of various immune measures at 14 days, 1.5 month, 3 months, and 6 months, and again after cross-over intervention at 14 days, 1.5 month, 3 months, and 6 months
Conditions and MedDRA coding
Measles, mumps, and rubella
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027011 | Measles | 100000004862 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- For researchers upon application after finalization of the trial.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503845-79-00 | The induction of respiratory immune responses by epicutaneous vaccination with the MMR vaccine | Rigshospitalet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age 18 to 34 years. MMR-naive. Healthy. Safe contraception for female participants.
Exclusion criteria 1
- Age < 18 or ≥ 35 years. MMR-vaccinated, or MMR wild type infected. Severe, chronic disease with potential implications for the immune response, or with anemia, or thrombocytopenia. Allergy towards any vaccine component (egg, neomycin). Fructose intolerance. Blood, or plasma, or human immune serum globulin transfusion within 3 months. Pregnancy or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint The primary trial endpoint is levels of measles-specific mucosal IgA immune response 3 months after EV compared with the standard MMRvaccine administration by subcutaneous/intramuscular injection as measured by ELISA methods. We hypothesize that there is no significant difference between the levels.
Secondary endpoints 1
- Nasal secretion and serum: Measles neutralizing antibodies measured by gold standard PRNT Measles, mumps, and rubella IgG, IgM and IgA measured by ELISA Full blood: Measles-specific CD4+ and CD8+ T-cell responses Tonsil brushings: Measles-specific CD4+ and CD8+ T-cell responses Side effects: Frequency of side effects/adverse events 30 days after vaccination will be compared
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4577957 · Product
- Active substance
- Rubella Virus Wistar Ra 27/3 Strain (Live, Attenuated) Produced in WI-38 Human Diploid Lung Fibroblasts
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAEPIDERMAL USE
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MORBILLI, COMBINATIONS WITH PAROTITIS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- EU/1/06/337/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD4577956 · Product
- Active substance
- Rubella Virus Wistar Ra 27/3 Strain (Live, Attenuated) Produced in WI-38 Human Diploid Lung Fibroblasts
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MORBILLI, COMBINATIONS WITH PAROTITIS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- EU/1/06/337/001
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Lone Graff Stensballe
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Lone Graff Stensballe
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring, Code 12 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
JMC, Dept. for Children and Adolescents, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-11-24 | 2025-09-30 | 2024-11-24 | 2025-06-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 20251022 MMR scarification VMK protocol_v10 | 10 |
| Recruitment arrangements - Extract (for publication) | MFR trial annonceindhold | 1 |
| Recruitment arrangements - Extract (for publication) | pictures for public announcement through forskningNU | 1 |
| Recruitment arrangements (for publication) | Plakat Skarificering_v2_20230515 | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_v2_2023_05_02_clean | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_v4_20231027_clean | 1 |
| Subject information and informed consent form (for publication) | Inklusionssprgeskema_v1_20230320 | 1 |
| Subject information and informed consent form (for publication) | S3_samtykke_v2_20230502_clean | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | m-m-rvaxpro-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | m-m-rvaxpro-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | 20251022 MMR scarification VMK protocol_v10_TC | 10 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-03 | Denmark | Acceptable 2023-06-19
|
2023-06-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-24 | |||
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-12-18 | Denmark | Acceptable 2024-03-05
|
2024-03-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-13 | Denmark | Acceptable 2024-03-05
|
2024-03-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-25 | Denmark | Acceptable 2024-11-24
|
2024-11-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-09 | Denmark | Acceptable | 2025-11-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-12 | Denmark | Acceptable 2025-11-18
|
2025-11-18 |