MonkeypoxNCT03745131
Cohort Study of Healthcare Workers Receiving Imvanex®
An observational study of Monkeypox, run by Public Health England at 5 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkeypox
- What is being tested?
- Blood draw
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 30 Oct 2018to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
- 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)
Show all 14Show fewer
- 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
Who cannot join
- Refusal by participant
- Age less than 18 years
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, FY3 8NR
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP
Royal Free London NHS Foundation Trust
London, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
About this study
Official title: 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.
Read the 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.
- Conditions
- Monkeypox
- Being tested
- Blood draw
- Keywords
- Immunisation, Modified Vaccinia Ankara, Imvanex, Imvamune, Vaccine
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood draw to obtain serum to determine anti-orthopox antibody titres.
| Study group | Role | What they receive |
|---|---|---|
| Pre-exposure prophylaxis recipients | 40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis. Receives: Other: Blood draw | |
| Post-exposure prophylaxis recipients | 40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw | |
| 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. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody responses to first dose of Imvanex®
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®.
Measured: 28-56 days following immunisation
Antibody titres following first dose of Imvanex®
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®.
Measured: 28-56 days following immunisation
Secondary outcomes (4)
Antibody responses to second dose of Imvanex®
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.
Measured: 28-56 days following immunisation
Antibody titres following second dose of Imvanex®
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®.
Measured: 28-56 days following immunisation
Neutralising antibody responses to first dose of Imvanex®
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.
Measured: 28-56 days following immunisation
Adverse events reported following vaccination with Imvanex®
Adverse events and serious adverse events by reported frequencies (reported retrospectively).
Measured: 28-56 days following immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start30 Oct 2018
- Primary completion30 May 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Collaborators
- Bavarian Nordic
- Responsible party
- Sponsor
- Investigators
- William Jake Dunning, MRCP PhD, Study director, Public Health EnglandMeera Chand, FRCPath, Study director, Public Health EnglandSema Mandal, MRCP FFPH, Principal investigator, Public Health EnglandNicholas Andrews, PhD, Principal investigator, Public Health EnglandTimothy Brooks, FRCPath, Principal investigator, Public Health EnglandMichael Beadsworth, MD MRCP, Principal investigator, Liverpool University Hospitals NHS Foundation TrustMichael Jacobs, FRCP PhD, Principal investigator, Royal Free London NHS Foundation TrustMatthias Schmid, MD FRCP, Principal investigator, Newcastle Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745131
- Sponsor's protocol ID
- MPX Imvanex Serology
- Other IDs
- 18/LO/1957, 255382
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30255836Hatmal 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.
PubMed 36263798
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK
- ClinicalTrials.gov ID
- NCT03745131
- Acronym / sponsor ID
- MPX Imvanex Serology
- Conditions
- Monkeypox
- Keywords
- Immunisation, Modified Vaccinia Ankara, Imvanex, Imvamune, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Collaborators
- Bavarian Nordic
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-exposure prophylaxis recipients | – | Other: Blood draw40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis. |
| Post-exposure prophylaxis recipients | – | Other: Blood draw40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments. |
| Control Group 1 | – | Other: Blood draw20 healthcare workers who provided specialist medical care to patients with monkeypox but declined the offer of vaccine as pre-exposure prophylaxis. |
| Control Group 2 | – | Other: Blood drawHealthcare workers not involved in the care of, and have not had known exposure to, patients with monkeypox and, therefore, were not offered vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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)
- A healthcare worker
- AND the individual has received Imvanex® during the outbreak period
Key exclusion criteria (2 listed)
- Refusal by participant
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw to obtain serum to determine anti-orthopox antibody titres. | Other | Control Group 1, Control Group 2, Post-exposure prophylaxis recipients, Pre-exposure prophylaxis recipients |
Primary outcome
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®.
Antibody titres following first dose of Imvanex®
Time frame: 28-56 days following immunisation
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®.
4 secondary outcomes
Antibody responses to second dose of Imvanex®
Time frame: 28-56 days following immunisation
Antibody titres following second dose of Imvanex®
Time frame: 28-56 days following immunisation
Neutralising antibody responses to first dose of Imvanex®
Time frame: 28-56 days following immunisation
Adverse events reported following vaccination with Imvanex®
Time frame: 28-56 days following immunisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 30255836Vaughan 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.
- Derived from this study: PubMed 36263798Hatmal 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.
- Public Health England News Story: Monkeypox case in England (update)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Jake Dunning, MRCP PhD study director
Public Health England
Meera Chand, FRCPath study director
Public Health England
Sema Mandal, MRCP FFPH principal investigator
Public Health England
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox, run by Public Health England at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody responses to first dose of Imvanex® (time frame: 28-56 days following immunisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745131, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.