An observational study in Monkeypox, sponsored by Public Health England. Completed at 5 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Public Health England · Observational
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.
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.
Public Health England is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria for pre-exposure prophylaxis cases:
Inclusion criteria for post-exposure prophylaxis cases:
Inclusion criteria for control group 1 (unvaccinated HCID staff caring for confirmed cases):
Inclusion criteria for control group 2 (general healthcare workers):
Exclusion criteria for all participants:
40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis.
Other: Blood draw
40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments.
Other: Blood draw
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
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.
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®.
Time frame: 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®.
Time frame: 28-56 days following immunisation
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.
Time frame: 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®.
Time frame: 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.
Time frame: 28-56 days following immunisation
Adverse events reported following vaccination with Imvanex®
Adverse events and serious adverse events by reported frequencies (reported retrospectively).
Time frame: 28-56 days following immunisation
Plan to share: Undecided
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Mpox (monkeypox)
Public Health England