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
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.
Lay summary of study results: People who survive sepsis often face ongoing health challenges long after leaving the hospital, when compared with a similar general population who did not have sepsis. One major concern is a weakened or altered immune system, which can increase the risk of new infections and increase the risk of death for years after surviving sepsis. Vaccines might help restore immune protection, but until now it has not been clear whether sepsis survivors respond to vaccines in the usual way as someone who did not have sepsis.In this study, we tested whether a common pneumonia vaccine (the 13-valent pneumococcal conjugate vaccine, PCV13) could reduce future infections in adults who survived sepsis. A total of 214 sepsis survivors were randomly assigned to receive either PCV13 or a placebo injection (an identical looking injection that contains no active medicine). The study participants who received PCV13 were compared with those who received placebo to see whether the vaccination reduced their risk of being re-admitted to hospital with infection or dying over the following year.
Although the study found that the vaccine did not significantly reduce this risk, the vaccine was safe and did not cause serious side effects. Blood tests showed that many participants did produce immune responses to the vaccine, but these responses varied widely from person to person. Differences in vaccine responses were linked to factors such as age, body weight, sex, and levels of altered immune system before vaccination.
For patients who survive sepsis, these findings suggest that although sepsis survivors can respond to vaccines, their immune systems behave differently from those of the general population. More research is needed to better understand these immune changes and to develop treatments that can improve long-term health and reduce infections in people who survive sepsis.
For caregivers, this study reinforces the importance of close follow-up and ongoing medical support for sepsis survivors. It also shows that the usual ways to prevent further illness may not work the same for everyone who has survived an episode of sepsis.
For policy makers, these findings suggest that one-size-fits-all vaccination strategies may be insufficient for sepsis survivors. There is a need for investment in post-sepsis care and in research that could meaningfully reduce long-term healthcare use and improve outcomes in this vulnerable population.
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