NIV001

• Research type

  Research Study

• Full title

  A phase I safety and immunogenicity study of a Nipah virus vaccine, ChAdOx1 NipahB, in healthy volunteers aged 18 to 55 in the UK

• IRAS ID

  1007433

• Contact name

  Andrew Pollard

• Contact email

  andrew.pollard@paediatrics.ox.ac.uk

• Sponsor organisation

  University of Oxford

• Eudract number

  2023-503872-25

• Research summary

  This is a trial of a new vaccine against Nipah virus. Nipah virus is a potentially fatal infection that can cause severe breathing problems and abnormalities with the nervous system including the brain. It was first identified in 1999 in a large outbreak in Malaysia and Singapore which was caused by transmission from infected pigs to humans. Since then, outbreaks have occurred almost annually in Bangladesh with human-to-human spread. The virus has the potential to cause large outbreaks. There are no approved treatments or vaccines.
  This study is of a vaccine called ChAdOx1 NipahB which has been developed by The University of Oxford. The vaccine is similar to the Oxford/AstraZeneca COVID-19 vaccine, however, the trial vaccine targets a component of the Nipah virus rather than the virus that causes COVID-19. This trial will be the first time the vaccine is given to humans. The purpose is to assess the safety and immune response.
  We will recruit 51 healthy people aged 18 to 55 years. Participants will be screened for eligibility with an optional online questionnaire and telephone call, followed by an in-person medical assessment. The first 6 eligible participants (cohort 1) will have two doses of vaccine 12 weeks apart. The following 45 participants (cohort 2) will be assigned, at random, to one of three groups. Group 1 will receive one dose of vaccine and one dose of sterile salt water, group 2 will receive two doses of vaccine, and group 3 will receive two doses of sterile salt water. The intramuscular injections will be given 12 weeks apart. The sterile salt water has no active ingredients which means it acts as a ‘placebo’. Apart from the researchers responsible for the randomisation, preparation and administration of the vaccine, the study team nor the participants will know whether vaccine or placebo were given until the end of the study. Participants will be followed up for 1 year from the first vaccination.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  23/SC/0268

• Date of REC Opinion

  19 Oct 2023

• REC opinion

  Further Information Favourable Opinion