Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02318069
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004675', 'term': 'Encephalitis, Tick-Borne'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of neutralising antibodies against TBE one month after two or three doses.', 'timeFrame': '18 months after the first dose', 'description': 'Determination of neutralising antibodies one month after completion of the first years vaccination series'}], 'secondaryOutcomes': [{'measure': 'Serum concentration of neutralising antibodies against TBE one month after the dose which will be given a year later', 'timeFrame': '18 months after the first dose has been given', 'description': 'Determination of neutralising antibodies one month after the dose which will be given a year later'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['immune response', 'TBE-vaccine', 'elderly', 'additional doses'], 'conditions': ['Tick-borne Encephalitis']}, 'descriptionModule': {'briefSummary': 'The risk for tick borne encephalitis increases in Sweden. Together with an increased awareness of the possibility to acquire protection by vaccination, this has led to an increase in the number of doses of the vaccine distributed in Sweden each year - now being approximately 400.000. The first year, two doses with an interval of 1 month is recommended for the general population, followed by a third dose approximately one year later and an additional booster dose three years after the third.\n\nPreliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group.\n\nThe investigators therefore aim to confirm results in a new study and to add a group with a double dose at day 0 and then a single dose at day 30 and 360', 'detailedDescription': 'The risk for tick borne encephalitis increases in Sweden. Together with an increased awareness of the possibility to acquire protection by vaccination, this has led to an increase in the number of doses of the vaccine distributed in Sweden each year - now being approximately 400.000. The first year, two doses with an interval of 1 month is recommended for the general population, followed by a third dose approximately one year later and an additional booster dose three years after the third.\n\nThe manufacturer of Encepur recommended a total of three doses to this age group using the same regimen as with "accelerated vaccination schedule (0+7+21 days). Unfortunately, geometrical mean of titers after 3 doses with the accelerated schedule is not superior to 2 doses given at 0+30 days The manufacturer of FSME-immune instead recommended that serology should be checked one month after the second dose and that a third dose should be given if titers are not sufficient (0+30+60 days). Unfortunately, determinations of titers in a large number of samples put severe strain on logistics and is not feasible in Sweden.\n\nIn order to try to improve immunity in the age group 60+ , the Department of Communicable Disease Control and Prevention in Stockholm therefore recommends a third dose two months after the first two doses to the age group 60+ (= 0+30+90 days).\n\nPreliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group\n\nPrimary aim: To study whether any differences remain before and one month after an additional dose at the following season Secondary aim: To study whether an additional dose of TBE vaccine 2 months after the second dose will improve protection in an age group 50+.\n\nPrimary endpoint: Serum concentration of neutralising antibodies against tick borne encephalitis one month after an additional dose the following year\n\nSecondary endpoints: Serum concentration of neutralising antibodies against tick borne encephalitis one month after two or three doses.\n\nCalculation of power: Depend on whether the aim is to determine differences in geometric mean titers or differences in seroconversion rate. The investigators prefer the former but have not settled for the least difference which would be interesting.\n\nInclusion critera: Age 50 years or more. Exclusion critera: previous tick borne encephalitis infection. Previously immunized with tick borne encephalitis vaccine. Anaphylactic reac tion to egg protein. Any disease or therapy which might suppress the immune response. Vaccination should be delayed if a participant has fever.\n\nStudy design. The investigators intend to give FSME-immune to 4 groups with varying vaccination schedules (see below) 50 participants will be randomized to each Group. A younger age group (50 participants between 18-49 years) will serve as controls and will be given FSME-immune according to standard recommendations (0+30 days)\n\nDays 0 7 21 30 90 360 Vaccine group 1 x x x Vaccine group 2 x x x x Vaccine group 3 x x x x Vaccine group 4 xx x x Controls x x x\n\nBlood samples (10 ml of blood) will be obtained for humoral response as shown below\n\nDays 0 60 120 360 400 Group 1 x x x x x Group 2 x x x x x Group 3 x x x x x Group 4 x x x x x Controls x x x x x\n\nAnalyses Samples are analysed for neutralising antibodies at the Swedish institute for Infectious disease control - other options possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 years or more (Control group 18 years)\n* generally healthy\n* no immunosuppressive condition\n* fertile women must use contraceptives\n\nExclusion Criteria:\n\n* Previous TBE infection\n* Previously immunized with TBE vaccine\n* Anaphylactic reaction to egg protein\n* Any disease or therapy which might suppress the immune response\n* Vaccination should be delayed if a participant has fever'}, 'identificationModule': {'nctId': 'NCT02318069', 'briefTitle': 'New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Sormland County Council, Sweden'}, 'officialTitle': 'Humoral Response to TBE Vaccine in Elderly (50+ Year Olds) After Changed Dosage Intervals/Number of Doses?', 'orgStudyIdInfo': {'id': '2011/4-31/2 - B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TBE vaccine at 0+30 days', 'description': 'This group of 50 participants will follow the standard recommendation and will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 days during the first year and an additional dose one year later', 'interventionNames': ['Biological: FSME-immune']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TBE vaccine at 0+7+21 days', 'description': 'This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 7 +21 days during the first year and an additional dose one year later', 'interventionNames': ['Biological: FSME-immune']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TBE vaccine at 0+30+90 days', 'description': 'This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 + 90 days during the first year and an additional dose one year later', 'interventionNames': ['Biological: FSME-immune']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'younger participants', 'description': 'This group of 50 participants in the age group 18-49 years will be given TBE vaccine 0.5 ml FSME immune at 0 +30 days during the first year and an additional dose one year later', 'interventionNames': ['Biological: FSME-immune']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'double dose of vaccine', 'description': 'This group of 50 participants will be given two doses of TBE vaccine 0.5 ml FSME immune at the first day of the study and an additional dose at day 30 as well as one year later', 'interventionNames': ['Biological: FSME-immune']}], 'interventions': [{'name': 'FSME-immune', 'type': 'BIOLOGICAL', 'description': '0.5 ml im as scheduled in the 5 arms', 'armGroupLabels': ['TBE vaccine at 0+30 days', 'TBE vaccine at 0+30+90 days', 'TBE vaccine at 0+7+21 days', 'double dose of vaccine', 'younger participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Dept infectious diseases', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '631 88', 'city': 'Eskilstuna', 'country': 'Sweden', 'facility': 'Dept infectious diseases', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}], 'overallOfficials': [{'name': 'lars rombo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sormland County Council, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Helsingfors university', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Lars Rombo', 'investigatorAffiliation': 'Sormland County Council, Sweden'}}}}