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Completed

NCT Number: NCT03745131

Cohort Study of Healthcare Workers Receiving Imvanex®

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.

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Key information

Conditions

Monkeypox Animal Diseases DNA Virus Infections Infections Mpox, Monkeypox Poxviridae Infections Primate Diseases Rodent Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, Lancashire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Collaborators

  • Bavarian Nordic

Registry information

Official study title

A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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