Cohort Study of Healthcare Workers Receiving Imvanex®

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745131
• Other study ID #: MPX Imvanex Serology
• Secondary ID: 18/LO/1957255382
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2018
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Monkeypox

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Public Health England	Bavarian Nordic

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome

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

External Links

•   Public Health England News Story: Monkeypox case in England (update)