Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
NCT ID: NCT03565159
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
214 participants
INTERVENTIONAL
2018-08-02
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Prevenar 13
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Prevenar 13
Pneumococcal polysaccharide conjugate vaccine
Sodium chloride 0.9%
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Sodium Chloride 0.9%
Placebo
Interventions
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Prevenar 13
Pneumococcal polysaccharide conjugate vaccine
Sodium Chloride 0.9%
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
* Splenectomy (previous or in the current admission)
* Diagnosis of pneumococcal sepsis in the current admission
* APACHE II score defined Immune deficiency or suppression, defined as presence of 1 or more of the following conditions:
* Documented human immunodeficiency virus (HIV) infection at any time-point pre-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.
* leukaemia (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
* lymphoma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) Hodgkin disease (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
* multiple myeloma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
* 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)
* chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
* 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).
* Receipt of an organ or bone marrow transplant with ongoing immunosuppressive medications. Failed previous transplant patients not currently on immunosuppression are eligible.
18 Years
90 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Manu Shankar-Hari, PhD
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust and King's College London
Locations
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Belfast Health and Social Care Trust
Belfast, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Countries
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Other Identifiers
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2017-002236-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
430321
Identifier Type: -
Identifier Source: org_study_id