Phase I Vaccine Study of MVA-Hanta
Research type
Research Study
Full title
A Phase I Study to assess the safety and immunogenicity of a MVA based vaccine for Hantavirus (MVA-Hanta)
IRAS ID
1012615
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN17868912
Research summary
Hantavirus disease is a dangerous disease caused by several different viruses, which can be fatal in up to 15% of cases. It leads to fever, diarrhoea and vomiting, bleeding dysfunction and organ failure. It is transmitted to humans mainly by rats. There are no current treatments other than symptom management, and no existing vaccines.
This study is testing a new vaccine for hantavirus disease. It is using the same, safe virus used to vaccinate against smallpox and more recently mpox, known as MVA (Modified Vaccinia Ankara). The MVA virus has been modified to expose the body to parts of the viruses which cause hantavirus disease. MVA has been given to hundreds of thousands of people as a vaccine previously and is known to be safe. The new vaccine is called MVA-Hanta.
We will give three, increasing doses of MVA-Hanta to 24 healthy people to test that it is safe, and that it provides an immune response to the viruses which cause Hantavirus disease. Eight people will receive each dose. We will start with the lowest dose, and if there are no safety concerns after giving it to all eight volunteers, we will begin giving the medium dose. We will repeat the same procedure before giving the highest dose. Each participant will receive two sets of vaccination, 28 days apart. For groups one and two, each set will be one injection of 0.5ml. For group three, each set will be two injections of 0.5ml.
All participants will complete a diary of their symptoms and be monitored closely, including with blood tests. Participants will be followed up for 6 months following their first vaccine administration.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0668
Date of REC Opinion
30 Oct 2025
REC opinion
Further Information Favourable Opinion