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Cohort Study of Healthcare Workers Receiving Imvanex®

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ClinicalTrials.gov Identifier: NCT03745131
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Bavarian Nordic
Information provided by (Responsible Party):
Public Health England

Brief 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. 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.

Condition or disease Intervention/treatment
Monkeypox Other: Blood draw

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox Vaccines

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.
Other: Blood draw
Blood draw to obtain serum to determine anti-orthopox antibody titres.

Post-exposure prophylaxis recipients
40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments.
Other: Blood draw
Blood draw to obtain serum to determine anti-orthopox antibody titres.

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.
Other: Blood draw
Blood draw to obtain serum to determine anti-orthopox antibody titres.

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.
Other: Blood draw
Blood draw to obtain serum to determine anti-orthopox antibody titres.




Primary Outcome Measures :
  1. 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®.

  2. 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®.


Secondary Outcome Measures :
  1. Antibody responses to second dose of Imvanex® [ Time Frame: 28-56 days following immunisation ]
    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.

  2. Antibody titres following second dose of Imvanex® [ Time Frame: 28-56 days following immunisation ]
    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®.

  3. Neutralising antibody responses to first dose of Imvanex® [ Time Frame: 28-56 days following immunisation ]
    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.

  4. Adverse events reported following vaccination with Imvanex® [ Time Frame: 28-56 days following immunisation ]
    Adverse events and serious adverse events by reported frequencies (reported retrospectively).


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745131


Locations
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United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, United Kingdom, FY3 8NR
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom, L7 8XP
Newcastle Hospitals NHS Foundation Trust
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Public Health England
Bavarian Nordic
Investigators
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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
Additional Information:
Publications:
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Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT03745131    
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 )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Public Health England:
Immunisation
Modified Vaccinia Ankara
Imvanex
Imvamune
Vaccine
Additional relevant MeSH terms:
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Monkeypox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections