NCT03745131

Cohort Study of Healthcare Workers Receiving Imvanex®

A Cohort Study of Serological Responses to MVA-BN Smallpox Vaccine (Imvamex®) Administered During a Monkeypox Outbreak in the UK

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Public Health England · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Monkeypox

Interventions

Type	Name	Description
OTHER	Blood draw	Blood draw to obtain serum to determine anti-orthopox antibody titres.

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-05-30
• Completion: 2019-11-30
• First posted: 2018-11-19
• Last updated: 2020-03-03

Locations

5 sites across 1 country: United Kingdom