Cohort Study of Healthcare Workers Receiving Imvanex®
- Conditions
- Monkeypox
- Interventions
- Other: Blood draw
- Registration Number
- NCT03745131
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pre-exposure prophylaxis recipients Blood draw 40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis. Control Group 1 Blood draw 20 healthcare workers who provided specialist medical care to patients with monkeypox but declined the offer of vaccine as pre-exposure prophylaxis. Post-exposure prophylaxis recipients Blood draw 40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments. Control Group 2 Blood draw Healthcare workers not involved in the care of, and have not had known exposure to, patients with monkeypox and, therefore, were not offered vaccine.
- Primary Outcome Measures
Name Time Method Antibody responses to first dose of Imvanex® 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® 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
Name Time Method Antibody responses to second dose of Imvanex® 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.
Antibody titres following second dose of Imvanex® 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®.
Neutralising antibody responses to first dose of Imvanex® 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.
Adverse events reported following vaccination with Imvanex® 28-56 days following immunisation Adverse events and serious adverse events by reported frequencies (reported retrospectively).
Trial Locations
- Locations (5)
Royal Liverpool and Broadgreen University Hospitals NHS Trust
🇬🇧Liverpool, Merseyside, United Kingdom
Newcastle Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
🇬🇧Blackpool, Lancashire, United Kingdom