- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03745131
Cohort Study of Healthcare Workers Receiving Imvanex®
March 2, 2020 updated by: Public Health England
A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK
During an outbreak of monkeypox in the UK in 2018, a third generation smallpox vaccine, Imvanex, was used for the first time to immunise healthcare workers who had been, or were expected to be, in contact with cases of monkeypox.
This study will examine the antibody responses in these healthcare workers compared to control groups, to provide evidence that the vaccine can produce a response consistent with protection when used in this context.
Study Overview
Detailed Description
This study intends to describe antibody responses to a third generation smallpox vaccine, Imvanex® (MVA-BN, Bavarian Nordic GmBH; also known as Imvamune®), in cohorts of individuals who received the vaccine for pre-exposure or post-exposure prophylaxis against monkeypox during a monkeypox outbreak in the UK.
In addition to quantifying anti-vaccinia virus antibody responses to vaccine, the study intends to demonstrate that vaccine-induced antibodies neutralise the specific monkeypox viruses involved in the UK outbreak, and also reference monkeypox viruses.
The use of Imvanex® during the UK outbreak represents the first ever use of Imvanex® as a public health intervention for a monkeypox outbreak, and this study will provide an opportunity to quantify and characterise antibody responses to Imvanex® administered in a non-trial setting.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, NW3 2QG
- Royal Free London NHS Foundation Trust
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London, United Kingdom, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust
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Lancashire
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Blackpool, Lancashire, United Kingdom, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust
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Merseyside
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Liverpool, Merseyside, United Kingdom, L7 8XP
- Royal Liverpool and Broadgreen University Hospitals NHS Trust
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Tyne And Wear
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Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
- Newcastle Hospitals NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthcare workers at NHS Airborne HCID Centres, and healthcare workers at other NHS hospitals that cared for monkeypox cases before they were transferred to HCID Centres.
Description
Inclusion criteria for pre-exposure prophylaxis cases:
- A High Consequence Infectious Disease (HCID) Centre healthcare worker involved in the care of a confirmed monkeypox case
- AND the individual has received Imvanex® during the outbreak period
- AND no known unprotected exposure to a monkeypox case (i.e. pre-exposure indication for vaccination)
Inclusion criteria for post-exposure prophylaxis cases:
- A healthcare worker
- AND the individual has received Imvanex® during the outbreak period
- AND unprotected exposure to a monkeypox case is believed to have occurred (i.e. post-exposure indication for vaccination)
Inclusion criteria for control group 1 (unvaccinated HCID staff caring for confirmed cases):
- A High Consequence Infectious Disease (HCID) Unit healthcare worker involved in the care of a confirmed monkeypox case
- AND the individual has NOT received Imvanex® during the outbreak period
- AND no known unprotected exposure to a monkeypox case
Inclusion criteria for control group 2 (general healthcare workers):
- A healthcare worker NOT involved in the care of a confirmed monkeypox case
- AND the individual has NOT received Imvanex® during the outbreak period
- AND no known unprotected exposure to a monkeypox case
Exclusion criteria for all participants:
- Refusal by participant
- Age less than 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-exposure prophylaxis recipients
40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis.
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Blood draw to obtain serum to determine anti-orthopox antibody titres.
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Post-exposure prophylaxis recipients
40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments.
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Blood draw to obtain serum to determine anti-orthopox antibody titres.
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Control Group 1
20 healthcare workers who provided specialist medical care to patients with monkeypox but declined the offer of vaccine as pre-exposure prophylaxis.
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Blood draw to obtain serum to determine anti-orthopox antibody titres.
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Control Group 2
Healthcare workers not involved in the care of, and have not had known exposure to, patients with monkeypox and, therefore, were not offered vaccine.
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Blood draw to obtain serum to determine anti-orthopox antibody titres.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibody responses to first dose of Imvanex®
Time Frame: 28-56 days following immunisation
|
The proportion of participants with anti-orthopox antibodies when measured at a single time point between days 28 and 56 following first dose of Imvanex®.
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28-56 days following immunisation
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Antibody titres following first dose of Imvanex®
Time Frame: 28-56 days following immunisation
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Geometric mean titres (GMTs) of anti-orthopox antibodies when measured at a single time point between days 28 and 56 following first dose of Imvanex®.
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28-56 days following immunisation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibody responses to second dose of Imvanex®
Time Frame: 28-56 days following immunisation
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The proportion of participants who have anti-orthopox antibodies when measured at day 14 following the second dose of Imvanex®, if a subset of individuals receive a second dose of Imvanex® during the lifetime of the study.
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28-56 days following immunisation
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Antibody titres following second dose of Imvanex®
Time Frame: 28-56 days following immunisation
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The geometric mean titres (GMTs) of anti-orthopox antibodies when measured at day 14 following the second dose of Imvanex®, if a subset of individuals receive a second dose of Imvanex®.
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28-56 days following immunisation
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Neutralising antibody responses to first dose of Imvanex®
Time Frame: 28-56 days following immunisation
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The proportion of participants who have demonstrable neutralising antibodies against the specific monkeypox viruses involved in the UK outbreak, in addition to reference monkeypox viruses.
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28-56 days following immunisation
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Adverse events reported following vaccination with Imvanex®
Time Frame: 28-56 days following immunisation
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Adverse events and serious adverse events by reported frequencies (reported retrospectively).
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28-56 days following immunisation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: William Jake Dunning, MRCP PhD, Public Health England
- Study Director: Meera Chand, FRCPath, Public Health England
- Principal Investigator: Sema Mandal, MRCP FFPH, Public Health England
- Principal Investigator: Nicholas Andrews, PhD, Public Health England
- Principal Investigator: Timothy Brooks, FRCPath, Public Health England
- Principal Investigator: Michael Beadsworth, MD MRCP, Liverpool University Hospitals NHS Foundation Trust
- Principal Investigator: Michael Jacobs, FRCP PhD, Royal Free London NHS Foundation Trust
- Principal Investigator: Matthias Schmid, MD FRCP, Newcastle Hospitals NHS Foundation Trust
- Principal Investigator: Christopher Meadows, FRCP FRCA, Guy's and St Thomas' NHS Foundation Trust
- Principal Investigator: Peter Flegg, MD FRCP, Blackpool Teaching Hospitals NHS Foundation Trust
- Principal Investigator: Heinz Weidenthaler, Bavarian Nordic GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vaughan A, Aarons E, Astbury J, Balasegaram S, Beadsworth M, Beck CR, Chand M, O'Connor C, Dunning J, Ghebrehewet S, Harper N, Howlett-Shipley R, Ihekweazu C, Jacobs M, Kaindama L, Katwa P, Khoo S, Lamb L, Mawdsley S, Morgan D, Palmer R, Phin N, Russell K, Said B, Simpson A, Vivancos R, Wade M, Walsh A, Wilburn J. Two cases of monkeypox imported to the United Kingdom, September 2018. Euro Surveill. 2018 Sep;23(38):1800509. doi: 10.2807/1560-7917.ES.2018.23.38.1800509.
- Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2018
Primary Completion (Actual)
May 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPX Imvanex Serology
- 18/LO/1957 (Other Identifier: London-West London & GTAC Research Ethics Committee)
- 255382 (Other Identifier: Integrated Research Application System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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