Cohort Study of Healthcare Workers Receiving Imvanex®

NCT03745131 | Completed

• 3 other identifiers: MPX Imvanex Serology18/LO/1957255382
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Monkeypox

Keywords

Immunisation; Modified Vaccinia Ankara; Imvanex; Imvamune; Vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Antibody responses to second dose of Imvanex®

  28-56 days following immunisation

• Antibody titres following second dose of Imvanex®

  28-56 days following immunisation

• Neutralising antibody responses to first dose of Imvanex®

  28-56 days following immunisation

• Adverse events reported following vaccination with Imvanex®

  28-56 days following immunisation

Study Arms (4)

Pre-exposure prophylaxis recipients

40 healthcare workers who provide specialist medical care to patients with monkeypox and who received vaccine as pre-exposure prophylaxis.

Other: Blood draw

Post-exposure prophylaxis recipients

40 healthcare workers who received vaccine as post-exposure prophylaxis following monkeypox-exposure risk assessments.

Other: Blood draw

Control Group 1

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

Control Group 2

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

Interventions

Blood draw OTHER

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

Control Group 1; Control Group 2; Post-exposure prophylaxis recipients; Pre-exposure prophylaxis recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)
• 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)
• 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
• 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

You may not qualify if:

• Refusal by participant
• Age less than 18 years

Sponsors & Collaborators

• Public Health England: lead
• Bavarian Nordic: collaborator

Study Sites (5)

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Newcastle Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• 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):1800509. doi: 10.2807/1560-7917.ES.2018.23.38.1800509.

  PMID: 30255836 BACKGROUND

• Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.

  PMID: 36263798 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William Jake Dunning, MRCP PhD

  Public Health England

  STUDY DIRECTOR

• Meera Chand, FRCPath

  Public Health England

  STUDY DIRECTOR

• Sema Mandal, MRCP FFPH

  Public Health England

  PRINCIPAL INVESTIGATOR

• Nicholas Andrews, PhD

  Public Health England

  PRINCIPAL INVESTIGATOR

• Timothy Brooks, FRCPath

  Public Health England

  PRINCIPAL INVESTIGATOR

• Michael Beadsworth, MD MRCP

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Michael Jacobs, FRCP PhD

  Royal Free London NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Matthias Schmid, MD FRCP

  Newcastle Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Christopher Meadows, FRCP FRCA

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Peter Flegg, MD FRCP

  Blackpool Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Heinz Weidenthaler

  Bavarian Nordic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: October 30, 2018
• Primary Completion: May 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 3, 2020

Record last verified: 2018-11

Locations

GB (5)