Vaccination for immune recovery following sepsis

Phase 4

Completed

• Conditions: Infection following recovery from sepsis; Infections and Infestations; Bacterial sepsis

• Registration Number: ISRCTN11401066
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-10
• Study Completion: 2023-07-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

1. Aged 18 years or older at screening
2. Registered with a General Practitioner
3. Admitted to intensive care unit or high dependence unit for sepsis (sepsis is defined as suspected or proven infection with a total Sepsis-related Organ Failure Assessment (SOFA) score of at least 2 points)
4. Improved clinical condition
5. Ready for step down to high dependence unit or ward-based care in the next 24-48 hours
6. Patient or their legal representative is able to provide written informed consent

Exclusion Criteria

1. Core temperature 38.0 °C or higher within the past 24 hours prior to study investigational medicinal product (IMP) administration
2. Hypersensitivity reaction (i.e. anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine
3. Vaccination administered to patient within 7 days of enrolment
4. Pregnant or lactating women
5. Limitations of care set, including not for resuscitation, not for readmission to critical care
6. Resident of nursing home, long-term care facility or other institution, or requirement of semi-skilling nursing care
7. Coagulopathy, defined as at least one of the following:
7.1. Platelet count less than 50 x 109/L
7.2. International normalized ratio (INR) greater than 1.3
8. APACHE II score-defined immune deficiency or supression, defined as at least one of the following conditions:
8.1. Documented human immunodeficiency virus (HIV) infection at any timepoint prior to the trial (if previous results are not available and/or current admission is not due to HIV infection, these patients do not need new testing and are considered eligible for the trial)
8.2. Leukaemia, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
8.3. Lymphoma, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
8.4. Hodgkin disease, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
8.5. Multiple myeloma, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
8.6. Malignancy, defined as presence of any malignancy that had been treated by or had been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
8.7. Chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
8.8. Receipt of immunosuppressive therapy, including steroids, within 3 months of study vaccine administration (For corticosteroids, prednisone or equivalent 0.5 mg/kg/day for 14 days or longer. Inhaled, intra- articular, and topical steroids are not considered immunosuppressive)

Study & Design

• Study Type: Interventional
• Study Design: Not specified