TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
Primary Purpose
Encephalitis, Tick-Borne
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Encephalitis, Tick-Borne
Eligibility Criteria
Inclusion Criteria:
- Subjects who participated in Study 223 will be eligible for participation in this study if:
- they understand the nature of the study, agree to its provisions and provide written informed consent
- they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223
- blood was drawn after their first booster vaccination in Study 223.
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
- received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
- have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
- are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml
- have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages).
Subjects will not be eligible for booster vaccination if they:
- are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial)
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
- are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
- have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223
- are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study
- do not agree to keep a Subject Diary.
- Subjects who meet the eligibility criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal.
- Subjects who have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.
- If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time.
- If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a TBE infection.
- If a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed.
Sites / Locations
- Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy
- Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji
Outcomes
Primary Outcome Measures
Seropositivity rate measured by Enzyme-Linked Immunosorbent Assay (ELISA) and/or Neutralization test (NT) 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503529
Brief Title
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
Official Title
Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess:
TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT),
TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT,
Safety of FSME-IMMUN 0.5ml after the second booster vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-Borne
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Other Intervention Name(s)
FSME-IMMUN 0.5 ml
Intervention Description
Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)
Primary Outcome Measure Information:
Title
Seropositivity rate measured by Enzyme-Linked Immunosorbent Assay (ELISA) and/or Neutralization test (NT) 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
Time Frame
24, 34, 46 and 58 months after the the first booster TBE vaccination in Study 223 and after the booster vaccination in this study (study ID 690701)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who participated in Study 223 will be eligible for participation in this study if:
they understand the nature of the study, agree to its provisions and provide written informed consent
they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223
blood was drawn after their first booster vaccination in Study 223.
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml
have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages).
Subjects will not be eligible for booster vaccination if they:
are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial)
suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223
are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study
do not agree to keep a Subject Diary.
Subjects who meet the eligibility criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal.
Subjects who have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.
If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time.
If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a TBE infection.
If a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryszard Konior, MD
Organizational Affiliation
The John Paul II Hospital, Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy
City
Debica
ZIP/Postal Code
33-200
Country
Poland
Facility Name
Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28545923
Citation
Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22.
Results Reference
derived
Learn more about this trial
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
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