Phase I Vaccine Study of MVA-CCHF
Research type
Research Study
Full title
A Phase I Study to assess the safety and immunogenicity of a MVA based vaccine for Crimean-Congo Haemorrhagic Fever (MVA-CCHF)
IRAS ID
268347
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2019-004724-38
ISRCTN Number
ISRCTN14935155
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The Crimean-Congo Haemorrhagic Fever (CCHF) Virus is a fatal disease that has spread across many countries in Africa, Middle East, Asia and Eastern Europe. This infection is spread by ticks and has a fatality rate of up to 80% with symptoms causing bruising, bleeding and organ failure. Currently there are no approved treatments for this disease. As a result of this we are proposing to conduct a Phase I study with a primary objective to assess the safety and immune response of a new vaccine for CCHF (MVA-CCHF).
This will be a single centre; first in human, dose escalation, open label study. We aim to recruit a total of 24 healthy volunteers who will each receive 2 vaccinations (on Day 0 and Day 28). Participants will be in the study for 12 months with approximately 13 scheduled visits, these will include screening, vaccination and follow up visits.
The study has two groups. Group 1 will be a dose escalation group and has a total of 18 volunteers, split into 3 subgroups (e.g. Subgroup 1A, 1B and 1C).
6 volunteers will be enrolled into each subgroup at a time. Once subgroup 1A has completed both vaccinations and their Week 5 follow up visit, a safety committee will be held to assess safety and will agree to dose escalate with the next subgroup 1B. This process is repeated until Subgroup 1C is completed.
The doses are given intra muscularly as follows:
Subgroup 1A: 2 doses of MVA-CCHF at 1 x 10^7 pfu
Subgroup 1B: 2 doses of MVA-CCHF at 5 x 10^7 pfu
Subgroup 1C: 2 doses of MVA-CCHF at 1 x 10^8 pfu
The most well tolerated dose from Group 1 will be used for Group 2 where a further 6 volunteers will be vaccinated.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0038
Date of REC Opinion
30 Mar 2020
REC opinion
Further Information Favourable Opinion