Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
Study NCT ID:
NCT04515368
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2020-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-06', 'releaseDate': '2022-08-10'}], 'estimatedResultsFirstSubmitDate': '2022-08-10'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007114', 'term': 'Immunization'}], 'ancestors': [{'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18FDG-PET/CT imaging', 'timeFrame': '4 hours', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}, {'measure': '18FDG- or 11C-PBR28-PET/CT imaging', 'timeFrame': '1 day', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}, {'measure': '18FDG- or 11C-PBR28-PET/CT imaging', 'timeFrame': '3 days', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}, {'measure': '18FDG- or 11C-PBR28-PET/CT imaging', 'timeFrame': '5 days', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}, {'measure': '18FDG- or 11C-PBR28-PET/CT imaging', 'timeFrame': '7 days', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}, {'measure': '18FDG-PET/CT imaging', 'timeFrame': '10 days', 'description': 'Quantification of PET activity at injection site and draining lymph nodes'}], 'secondaryOutcomes': [{'measure': 'Diary card of reactogenicity', 'timeFrame': '0 to 10 days', 'description': 'Recording of solicited and unsolicited adverse events after immunisation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Positron-Emission Tomography', 'Immunization Reaction']}, 'descriptionModule': {'briefSummary': "This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:\n\n1. To methodically characterise relative anatomical distribution and intensity of post-immunisation innate immune activation visualised by PET-CT after immunisation with adjuvanted and non-adjuvanted vaccines.\n2. To correlate PET/CT changes with diary card recorded symptoms of reactogenicity."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to read and understand the informed consent form (ICF), and understand study procedures\n2. Signed the ICF\n3. Healthy male aged 18'Äì55 years inclusive\n4. BMI 19'Äì27 kg/m2\n5. Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine\n6. Available for follow-up for the duration of the study\n7. Is, in the opinion of the investigator, healthy on the basis of a medical history, symptom directed medical examination and vital signs\n8. Have not undergone research radiation exposures, and agree to avoid such exposures, for 12 months before/after this study\n9. Be willing to avoid vigorous exercise or contact sports between vaccination and PET scan (e.g. gym workouts, prolonged cycling, rowing, martial arts or rugby)\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation\n2. Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of the PET scan. (Topical/ocular/nasal/inhaled steroids are allowed.)\n3. Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype\n4. Currently participating in a clinical study with a drug or device\n5. Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study\n6. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent"}, 'identificationModule': {'nctId': 'NCT04515368', 'acronym': 'PETVACC', 'briefTitle': 'A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity', 'orgStudyIdInfo': {'id': 'PETVACC'}, 'secondaryIdInfos': [{'id': '15/LO/2039', 'type': 'OTHER', 'domain': "London 'Äì Surrey Borders Research Ethics Committee"}, {'id': '191407', 'type': 'OTHER', 'domain': 'IRAS project ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fendrix', 'description': "Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3¬≠O¬≠desacyl¬≠4'¬≠ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat.", 'interventionNames': ['Biological: Immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Bexsero', 'description': 'Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.', 'interventionNames': ['Biological: Immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Fluad', 'description': 'Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat.', 'interventionNames': ['Biological: Immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Seasonal Trivalent Influenza Vaccine', 'description': "Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat.", 'interventionNames': ['Biological: Immunization']}], 'interventions': [{'name': 'Immunization', 'type': 'BIOLOGICAL', 'description': 'Immunisation with one of four licensed vaccines', 'armGroupLabels': ['Bexsero', 'Fendrix', 'Fluad', 'Seasonal Trivalent Influenza Vaccine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David JM Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-10', 'type': 'RELEASE'}, {'date': '2023-06-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}