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

  katrina.pollock@paediatrics.ox.ac.uk

• Sponsor organisation

  University of Oxford Research Governance, Ethics & Assurance (RGEA) Team

• Eudract number

  2022-003889-20

• ISRCTN Number

  ISRCTN12351734

• Clinicaltrials.gov Identifier

  NA

• 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.

• 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