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

Status

Completed

Conditions

Intervention / Treatment

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

      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
        • Newcastle Hospitals NHS Foundation Trust

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

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®.
28-56 days following immunisation
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®.
28-56 days following immunisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28-56 days following immunisation
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®.
28-56 days following immunisation
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.
28-56 days following immunisation
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).
28-56 days following immunisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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