CCHF01
Research type
Research Study
Full title
A phase 1 safety and immunogenicity study of a Crimean-Congo haemorrhagic fever virus vaccine, ChAdOx2 CCHF, in healthy adult volunteers in the UK
IRAS ID
1007128
Contact name
Katrina Pollock
Contact email
Sponsor organisation
University of Oxford Research Governance, Ethics & Assurance (RGEA) Team
Eudract number
2022-003889-20
ISRCTN Number
ISRCTN12351734
Research summary
Research Summary
Crimean-Congo haemorrhagic fever (CCHF) is caused by a virus which can result in severe illness and death. Cases occur in many parts of the world, including southern Europe, the Middle East, Africa and south-west Asia. The World Health Organisation estimates that 3 billion people live in areas at risk, and the CCHF virus infects up to 15,000 people per year, causing 500 deaths.
The virus is transmitted by ticks, which can live on many domestic and wild animals, including cattle, sheep and goats. Humans usually become infected after a tick bite, although the virus can also be caught from close contact with infected animals or humans. In some people Infection causes no symptoms, but in others it can cause very serious illness with impaired blood clotting, which can lead to severe bleeding. Up to 40% of people admitted to hospital with the infection die. There are currently no specific, effective treatments and there is no approved vaccine. The only vaccine for humans was developed in the early 1970s in Russia; it is not suitable for widespread use.All participants will attend a screening visit, to decide their eligibility obtain their consent to take part. At the next visit the first study vaccination will be given; the second will be given 12 weeks later. Any symptoms after the vaccinations will be recorded in an electronic diary. All participants will be followed up for one year after the first vaccination.
The first six participants will attend a total of 15 study visits (1 screening, 2 vaccination and 12 follow up visits). The remaining participants will attend a total of 11 study visits (1 screening, 2 vaccination and 8 follow up visits). All visits will include a blood test.Summary of Results
"CCHF lay summary
CCHF01 a study of a new vaccine against Crimean-Congo haemorrhagic fever (CCHF) virus in healthy adults.
CCHF is a potentially fatal viral illness spread by ticks, which can live on many wild and domestic animals, including cattle, sheep and goats. Humans usually acquire CCHF infection following a tick bite, although it can also be acquired from contact with blood or tissues from infected animals or humans. Infection may be asymptomatic, but it can cause severe disease with impaired blood clotting leading to serious bleeding and death. The disease occurs over a wide geographical area including southern Europe, Africa, south-east Asia and the Middle East. According to World Health Organisation estimates, 3 billion people are at risk from CCHF, and there are 10,000 to 15,000 cases each year, resulting in 500 deaths.
The study vaccine is called ChAdOx2 CCHF. It has been developed by the University of Oxford, using similar technology to the Oxford/AstraZeneca COVID-19 vaccine. This study will be the first to give this vaccine to humans. Its purpose is to assess the tolerability and safety of the vaccine and to measure immune responses after vaccination. The study will also investigate whether having received other similar (adenovirus based) vaccines in the past affects the response to ChAdOx2 CCHF.
We recruited 46 people aged between 18 and 55 years. Volunteers were screened for eligibility with an initial online questionnaire followed by an in-person medical assessment. Eligible participants were invited to attend the first vaccination visit. A second vaccination was given approximately 12 weeks later. Participants recorded symptoms after each vaccination in an e-diary. Blood tests were taken to assess response to the vaccinations. Adverse events were recorded throughout the trial and participants will be followed up for 1 year.
Overall, there were no safety concerns reported by participants, and there were no serious adverse events reported in this study. ChAdOx2 CCHF vaccine generated peak antibody responses 14 days after the second dose of ChAdOx2 CCHF vaccine. These responses were durable at one year post first immunisation. ChAdOx2 CCHF vaccine generated response appeared to be higher in individuals who had no previous ChAdOx exposure after the first dose but not second dose of the vaccine. Response remains higher compared to baseline levels for both groups."REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0420
Date of REC Opinion
2 Aug 2023
REC opinion
Further Information Favourable Opinion