Vaccination for immune recovery following sepsis:The VACIRiSS Trial

• Research type

  Research Study

• Full title

  Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors: randomized placebo-controlled trial

• IRAS ID

  230431

• Contact name

  Manu Shankar-Hari

• Contact email

  manu.shankar-hari@gstt.nhs.uk

• Sponsor organisation

  Guys and St Thomas NHS Foundation Trust

• Eudract number

  2017-002236-17

• Duration of Study in the UK

  3 years, 8 months, 31 days

• Research summary

  Title: Could vaccinating sepsis survivors reduce the risk of getting new infections and death?

  Why this trial?
  Sepsis is a common and life threatening condition. Patients who have recovered from sepsis and are about to leave hospital (sepsis survivors) are still at increased risk of getting new infections, which in turn increases their risk of death. The main reason for these re-infections is the reduced function of their immune system. This trial tests whether treating them with a very safe vaccine reduces risk of reinfections and death patient who have recovered from sepsis.

  Who would be eligible?
  In this trial, sepsis patients as they become well enough to leave the intensive care unit, will be approached to ascertain whether they would be willing to participate in the study. After obtaining consent, eligibility for the trial will be checked. Patients who are eligible will be given the vaccine or placebo.

  Where would this trial be conducted?
  This trial would initially be conducted in 6 hospitals across the United Kingdom.

  How long will the study last and what will the participants undergo?
  Patients in the trial, would be followed-up regularly for one-year to see how they recover from sepsis (using blood tests and questionnaires), how many get repeated infections and when. After completion of the trial, we would assess whether vaccination did indeed enhance the recovery of the immune system to reduce the risk of repeated infections.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  18/EM/0079

• Date of REC Opinion

  16 Apr 2018

• REC opinion

  Further Information Favourable Opinion