Monkeypox Clinical Trial
Official title:
A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK
Verified date | November 2018 |
Source | Public Health England |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 30, 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | Lancashire |
United Kingdom | Royal Liverpool and Broadgreen University Hospitals NHS Trust | Liverpool | Merseyside |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
United Kingdom | Royal Free London NHS Foundation Trust | London | |
United Kingdom | Newcastle Hospitals NHS Foundation Trust | Newcastle Upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Public Health England | Bavarian Nordic |
United Kingdom,
Vaughan A, Aarons E, Astbury J, Balasegaram S, Beadsworth M, Beck CR, Chand M, O'Connor C, Dunning J, Ghebrehewet S, Harper N, Howlett-Shipley R, Ihekweazu C, Jacobs M, Kaindama L, Katwa P, Khoo S, Lamb L, Mawdsley S, Morgan D, Palmer R, Phin N, Russell K, Said B, Simpson A, Vivancos R, Wade M, Walsh A, Wilburn J. Two cases of monkeypox imported to the United Kingdom, September 2018. Euro Surveill. 2018 Sep;23(38). doi: 10.2807/1560-7917.ES.2018.23.38.1800509. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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®. | 28-56 days following immunisation | |
Primary | 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®. | 28-56 days following immunisation | |
Secondary | 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. | 28-56 days following immunisation | |
Secondary | 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®. | 28-56 days following immunisation | |
Secondary | 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. | 28-56 days following immunisation | |
Secondary | Adverse events reported following vaccination with Imvanex® | Adverse events and serious adverse events by reported frequencies (reported retrospectively). | 28-56 days following immunisation |
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