Sepsis
Conditions
Brief summary
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
Detailed description
The aim of VACIRiSS trial is to evaluate the immunogenicity and heterologous effects of single dose 13-valent conjugate pneumococcal vaccine (PCV-13) in preventing infection related rehospitalisation in sepsis survivors and to collect outcome event data with necessary precision to inform future definitive trial design.
Interventions
BIOLOGICALPrevenar 13
Pneumococcal polysaccharide conjugate vaccine
OTHERSodium Chloride 0.9%
Placebo
Sponsors
National Institute for Health Research, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients who meet all the following inclusion criteria are eligible to participate in the trial. * Male or female adult patients aged 18 years or older on the date of screening for the trial * Registered with a General Practitioner * Reason for admission to intensive care unit or high dependence unit (HDU) was sepsis * Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 - 48 hours * Provision of written informed consent by the patient OR by patient's Legal Representative OR Professional Consultee.
Exclusion criteria
Patients who meet one or more of the following will be excluded from the trial. * Core temperature ≥38.0°C within the past 24 hours prior to study IMP administration. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. * Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevenar 13 or any diphtheria toxoid-containing vaccine. * Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment. * Pregnant and lactating women. * Limitations of care set including not for resuscitation, not for readmission to critical care. * Residence in a nursing home, long-term care facility, or other institution, or requirement of semiskilled nursing care. (An ambulatory subject who was a resident of a retirement home or village is eligible for the trial.) * As the IMP is administered intra muscularly, coagulopathy defined as platelet count less than 50 x 109/L and/or International Normalized Ratio (INR) greater than 1.3. For this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary - Time to Event | Up to 365 days | Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary - Precision Estimates | Up to 365 days | Outcome event data to inform future definitive trial, including: \- proportion of rehospitalisation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory - Immune recovery patterns | Day 0 (baseline) to Day 90 | Differences between the intervention and control arms of the following: anti-pneumococcal antibody |
Countries
United Kingdom
Outcome results
None listed