Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
218
Countries
1
Sites
6
Mpox infection
Primary To assess the rate of change of (durability) of, and factors associated with, MVA-specific antibodies after at W48 post vaccination with MVA
Key facts
- Sponsor
- University College Dublin
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 29 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Primary
To assess the rate of change of (durability) of, and factors associated with, MVA-specific antibodies after at W48 post vaccination with MVA
Secondary objectives 6
- Development of MVA-specific antibodies at W6 after first dose
- Neutralising capacity of vaccine-induced immune response for Mpox virus in vitro culture at week 6 and 48
- Prevalence of Mpox seroconversion
- Prevalence of active Mpox infection
- Prevalence of active STIs at inclusion (HAV, HBV, HCV, Syphilis, Chlamydia and Gonorrhoea) and prevalence of participants with chronic HIV infection, HBV, HCV
- Incidence of STIs at week 6,12 and 48
Conditions and MedDRA coding
Mpox infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Be ≥ 18 years old
- ● Understand the study procedures, be able to comply with the procedures, and voluntarily agree to participate by giving written, informed consent for the trial
- ● Eligible for 1 or 2 doses of MVA for Mpox prevention as per NIAC guidelines OR have received first dose of MVA <28 days previously for Mpox prevention
Exclusion criteria 5
- Unable or unwilling to given informed consent
- ● Have a contraindication to MVA vaccination
- ● Have a documented, pre-existing allergy to any component of the vaccine
- ● Have a clinical and/or laboratory diagnosis of Mpox prior to recruitment
- ● Pregnant or breastfeeding women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Mean geometric MVA-specific antibody titres at week 48
- Mean rate of change in MVA-specific antibody titres post week 6 to week 48
Secondary endpoints 6
- Absolute mean change from baseline in MVA-specific antibody 6 weeks post first vaccine
- Neutralising capacity of vaccine-induced immune response for Mpox virus in vitro culture at weeks 6 and 48
- Detection of Mpox-specific antibodies at week 0,2,6,12 and 48
- Detection of Mpox DNA on anorectal, throat or vaginal swabs at week 0, 2, 6, 12 and 48.
- Frequency of active STIs at inclusion (HAV (IgM), HBV, HCV, Syphilis, Chlamydia and Gonorrhoea and frequency of participants with chronic HIV infection, HBV or HCV
- Incidence of STIs (HAV (IgM), HBV, HCV, HIV, Syphilis, Chlamydia and Gonorrhoea) at week 6,12 and 48
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10294306 · Product
- Active substance
- Modified Vaccinia Ankara – Bavarian Nordic Live Virus
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BX — OTHER VIRAL VACCINES
- Marketing authorisation
- EU/1/13/855/002
- MA holder
- BAVARIAN NORDIC A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10294307 · Product
- Active substance
- Modified Vaccinia Ankara – Bavarian Nordic Live Virus
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.50 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BX — OTHER VIRAL VACCINES
- Marketing authorisation
- EU/1/13/855/002
- MA holder
- BAVARIAN NORDIC A/S
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University College Dublin
- Sponsor organisation
- University College Dublin
- Address
- Catherine Mcauley Centre, 21 Nelson Street, Phibsborough 21 Nelson Street Phibsborough
- City
- Dublin 7
- Postcode
- DUB LIN7
- Country
- Ireland
Scientific contact point
- Organisation
- University College Dublin
- Contact name
- Joanne Byrne
Public contact point
- Organisation
- University College Dublin
- Contact name
- Aleksandra Sadlocha
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Ongoing, recruitment ended | 218 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
St James's Hospital
Infectious Diseases, James's Street, D08 NHY1, Dublin 8
St Vincent's University Hospital
Infectious Diseases, Nutley Lane Donnybrook, Elm Park, Dublin 4
Beaumont Hospital
Infectious Diseases, Beaumont Road, Beaumont, Dublin 9
University Hospital Galway
Infectious Diseases, Newcastle Road, H91 YR71, Galway
Mater Misericordiae University Hospital
Infectious Diseases, Eccles Street, D07 R2WY, Dublin 7
Cork University Hospital
Infectious Diseases, Wilton, T12 DC4A, Cork
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 |
|---|---|---|---|---|---|
| Ireland | 2024-06-29 | 2024-09-06 | 2026-05-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-65860
- Sponsor became aware
- 2025-01-06
- Date of breach
- 2025-01-03
- Submission date
- 2025-01-09
- Member states concerned
- Ireland
- Categories
- Regulation
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- An email containing personal data from trial participant MVX01023 at site 01 (St Vincents University Hospital) was sent to another individual who was also participating in the trial. The email was an internal site referral email in order to refer the participant to the relevant clinical team for appropriate clinical follow up and contained the participants name, DOB, MRN and lab results (syphilis and gonorrhea). The personal information was contained in the body of the email.
The email was sent on Friday 3-Jan-2025 at 18.03 from one of the study research nurses. The email was intended for and sent to a number of members of the Infectious Disease clinical team and in error the incorrect recipient was added. The research nurse who sent the email was not at the time aware of the error.
The incident was detected on 06-Jan-2025 at 09:30 when one of the cc'd Infectious Disease (ID) registrars’ phoned the research nurse indicating a wrong email address might have been included in the referral email.
The Research Nurse (RN) checked and confirmed it was an incorrect email address cc'd. The incorrect email address belonged to another participant of the study.
The individual who received the email incorrectly, emailed the RN on 03-Jan-2025 at 18:29 stating that they may have been sent a wrong email as the name was not theirs, and confirmed that they had deleted the email. The RN phoned this individual on morning of 6-Jan-2025 to apologize, and they confirmed again over the phone that they deleted the email.
On 06-Jan-2025 at approx. 13:30 the RN informed the CRC Lead Nurse at SVUH and the Infectious Disease (ID) Team and the Principal Investigator regarding this incident and it was agreed to contact SVUH Data Protection Officer for guidance. The site DPO subsequently notified Sponsor (UCD) DPO on same day.
The UCD (Sponsor) CRC CRA was informed by the research nurse via email on the 6-Jan-2025 and the Director of UCD CRC was informed on the 7-Jan-2025, subsequently informing the Director of Trial Operations on the same day.
The issues impact is on the privacy rights of the trial participant which they are fundamentally entitled to. - Sponsor actions
- Corrective Actions
Action: The individual who received the email in error, confirmed both via email (3-Jan-2025) and verbally over the phone (6-Jan-2025) that they have deleted the email.
Responsible: Research Nurse
Status: Complete; 6-Jan-2025
Action: A communication to all Infectious Disease team members who were in receipt of the initial email was sent on the 6-Jan-2025 at 13.48 advising ‘DO NOT REPLY TO THIS EMAIL’ so no further emails are sent to the incorrect email address.
Responsible: Research Nurse
Status: Complete; 6-Jan-2025
Action: The Principal Investigator and site team agreed to stop the current process of referral with immediate effect until a new process is established.
Responsible: PI
Status: Complete; 6-Jan-2025
Action: The sites Data Protection Officer (DPO) was notified on 06-Jan-2025 and advised to create a Clinical Incident (DATIX), inform the study sponsor and the data controller of the study. They in turn notified the UCD DPO.
Responsible: Research Nurse
Status: Complete; 6-Jan-2025
Action: The data breach was notified to the national Data Protection Commissioner on 8-Jan-2025 at 18.25
Responsible: Sponsor DPO
Status: Complete; 08-Jan-2025
Action: Action: The affected participant was informed of the data breach on 09-Jan-2025 during a clinic visit by one of the trial Sub Investigators. The Sub-I apologised to the participant, explained the different actions that were being taken and offered them details regarding making a formal complaint should they wish to do so.
Responsible: Sub-I (Consultant on clinic)
Status: Complete; 9-Jan-2025
Action: Serious breach was notified to the HPRA via CTIS on 9-Jan-2025.
Responsible: Director of Trial Operations
Status: Complete; 9-Jan-2025
Action: A CAPA planned prepared in order to fully document the event and capture all actions taken and planned.
Responsible: Director of Trial Operations
Status: Pending
Due Date: 30-Jan-2025
Preventative Actions
Action: The site team will implement a new process, whereby referral emails will only be sent to ID Consult generic email to reduce the number of recipients and opportunity to include unintended recipients.
This referral email will also only contain patient initials, MRN number and a request to review the participants results on central system. It will not contain any clinical information.
Responsible Party: Principal Investigator and Site Team
Status: Pending
Due Date: 15-Jan-2025
Action: A communication was sent to CRC research nursing team reminding all of their responsibilities with regards to data protection.
Responsible Party: Associate Director Nursing, UCD CRC
Status: Completed; 08-Jan-2025
Action: The CRC research nursing team have been requested to repeat the HSELand training on ‘Fundamentals of GDPR’.
Responsible Party: Associate Director Nursing, UCD CRC
Status: Pending
Due Date: 30-Jan-2025
Action: Re-training will be conducted with the investigator and site staff.
Responsible Party: Clinical Research Associate
Status: Pending
Due Date: 30-Jan-2025
Action: Explore the option to set up a study specific email address to be used for patient communication (making appointments and sending PILs, not sharing of clinical information) to remove patient email addresses from individual personnel work emails.
Responsible Party: Associate Director of Nursing, UCD CRC
Status: Pending
Due Date: 30-Jan-2025
The CAPA plan will be filed in the TMF (Trial Oversight - Quality Plan) and in the Quality folder of Sponsor internal shared drive.
| Organisation | City | Country | Type |
|---|---|---|---|
| St Vincent's University Hospital | Dublin 4 | Ireland | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-507881-19-00_Clean | 9 |
| Recruitment arrangements (for publication) | Certificate of Accuracy for All Documents | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Script V2 13 Feb 2025_EN | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Script V2 13 Feb 2025_ES | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Script V2 13 Feb 2025_ES_Translation Certificate | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Script V2 13 Feb 2025_PT | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Script V2 13 Feb 2025_PT_Translation Certificate | 2 |
| Recruitment arrangements (for publication) | Mpox Advertisement Plan 27102023 | 1 |
| Recruitment arrangements (for publication) | MPOX STORY | 1 |
| Recruitment arrangements (for publication) | MPOX VIDEO AD SCRIPT v1 01 Nov 2024 | 1 |
| Recruitment arrangements (for publication) | Mpox-Vax Advertisements | 1 |
| Recruitment arrangements (for publication) | MPOX-VAX_PIL V3 23Aug2024_English_ Tracked Changes | 1 |
| Recruitment arrangements (for publication) | NREC-CT-Recruitment-and-informed-consent-procedure-MPOXVAX | 1 |
| Recruitment arrangements (for publication) | Portugeuse translation plan Mpox Advertisement Plan | 1 |
| Recruitment arrangements (for publication) | Spanish translation Mpox Advertisement Plan | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_en_Clean | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_es_Clean | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_pt_Clean | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imvanex epar May2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imvanex epar May2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | imvanex-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | imvanex-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Package-Insert-JYNNEOS_1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Package-Insert-JYNNEOS_1 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2023-507881-19-00_Clean | 9 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-01 | Ireland | Acceptable 2024-03-04
|
2024-03-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-13 | Ireland | Acceptable | 2024-04-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-08 | Ireland | Acceptable | 2024-04-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-19 | Ireland | Acceptable | 2024-04-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-26 | Ireland | Acceptable 2024-08-29
|
2024-08-29 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-07 | Ireland | Acceptable | 2024-12-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-06 | Ireland | Acceptable 2025-06-16
|
2025-06-16 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-07 | Ireland | Acceptable 2025-10-13
|
2025-10-13 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-25 | Ireland | Acceptable 2026-01-08
|
2026-02-04 |