Monkeypox
Conditions
Keywords
Immunisation, Modified Vaccinia Ankara, Imvanex, Imvamune, Vaccine
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.
Interventions
OTHERBlood draw
Blood draw to obtain serum to determine anti-orthopox antibody titres.
Sponsors
Bavarian Nordic
Public Health England
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United Kingdom
Outcome results
None listed