Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT03565159
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2018-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory - Immune recovery patterns', 'timeFrame': 'Day 0 (baseline) to Day 90', 'description': 'Differences between the intervention and control arms of the following:\n\nanti-pneumococcal antibody'}, {'measure': 'Exploratory - Immune recovery patterns', 'timeFrame': 'Day 0 (baseline) to Day 90', 'description': 'Differences between the intervention and control arms of the following:\n\nB cell subsets, T cell subsets and monocyte HLA-DR and PD-1 expression), function and leukocyte transcriptome'}], 'primaryOutcomes': [{'measure': 'Primary - Time to Event', 'timeFrame': 'Up to 365 days', 'description': 'Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms.'}], 'secondaryOutcomes': [{'measure': 'Secondary - Precision Estimates', 'timeFrame': 'Up to 365 days', 'description': 'Outcome event data to inform future definitive trial, including:\n\n\\- proportion of rehospitalisation'}, {'measure': 'Secondary - Precision Estimates', 'timeFrame': 'Up to 365 days', 'description': '\\- proportions of reinfections'}, {'measure': 'Secondary - Precision Estimates', 'timeFrame': 'Up to 365 days', 'description': '\\- proportions of reinfection related rehospitalisation'}, {'measure': 'Secondary - Precision Estimates', 'timeFrame': 'Up to 365 days', 'description': '\\- time to first all cause rehospitalisation and'}, {'measure': 'Secondary - Precision Estimates', 'timeFrame': 'Up to 365 days', 'description': '\\- time to first infection requiring antibiotic therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients who meet all the following inclusion criteria are eligible to participate in the trial.\n\n* Male or female adult patients aged 18 years or older on the date of screening for the trial\n* Registered with a General Practitioner\n* Reason for admission to intensive care unit or high dependence unit (HDU) was sepsis\n* Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 - 48 hours\n* Provision of written informed consent by the patient OR by patient's Legal Representative OR Professional Consultee.\n\nExclusion Criteria:\n\nPatients who meet one or more of the following will be excluded from the trial.\n\n* 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.\n* Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevenar 13 or any diphtheria toxoid-containing vaccine.\n* Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment.\n* Pregnant and lactating women.\n* Limitations of care set including not for resuscitation, not for readmission to critical care.\n* 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.)\n* 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 exclusion criteria bloods taken within 72 hours of screening are valid. If these standard of care blood results are not available, then these should form part of the screening bloods for assessing eligibility.\n* Splenectomy (previous or in the current admission)\n* Diagnosis of pneumococcal sepsis in the current admission\n* APACHE II score defined Immune deficiency or suppression, defined as presence of 1 or more of the following conditions:\n* 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.\n* leukaemia (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)\n* 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)\n* multiple myeloma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)\n* 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)\n* chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome\n* 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).\n* Receipt of an organ or bone marrow transplant with ongoing immunosuppressive medications. Failed previous transplant patients not currently on immunosuppression are eligible."}, 'identificationModule': {'nctId': 'NCT03565159', 'acronym': 'VACIRiSS', 'briefTitle': 'Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors', 'orgStudyIdInfo': {'id': '430321'}, 'secondaryIdInfos': [{'id': '2017-002236-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prevenar 13', 'description': 'A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.', 'interventionNames': ['Biological: Prevenar 13']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride 0.9%', 'description': 'A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.', 'interventionNames': ['Other: Sodium Chloride 0.9%']}], 'interventions': [{'name': 'Prevenar 13', 'type': 'BIOLOGICAL', 'description': 'Pneumococcal polysaccharide conjugate vaccine', 'armGroupLabels': ['Prevenar 13']}, {'name': 'Sodium Chloride 0.9%', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Sodium chloride 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'NHS Lothian', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NP20 2EF', 'city': 'Newport', 'country': 'United Kingdom', 'facility': 'Aneurin Bevan University Health Board', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'South Tyneside and Sunderland NHS Foundation Trust', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}], 'overallOfficials': [{'name': 'Manu Shankar-Hari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust and King's College London"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Undecided', 'ipdSharing': 'YES', 'accessCriteria': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}