TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

• ClinicalTrials.gov Identifier: NCT00503529
• Recruitment Status: Completed
• First Posted: July 18, 2007
• Last Update Posted: May 21, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 17, 2007
• First Posted Date: July 18, 2007
• Last Update Posted Date: May 21, 2015
• Study Start Date: July 2007
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 5, 2008): 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) ]
• Original Primary Outcome Measures (submitted: July 17, 2007): 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
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: July 17, 2007)

• Seropositivity rate measured by ELISA 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
• Seropositivity rate measured by NT 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
• Antibody concentration 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study measured by ELISA
• Antibody titers 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study measured by NT
• Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by ELISA
• Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by NT
• Injection site reactions and systemic reactions after the booster vaccination in this study

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Encephalitis, Tick-Borne

Intervention

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)

Other Name: FSME-IMMUN 0.5 ml

• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 16, 2010): 314
• Original Estimated Enrollment (submitted: July 17, 2007): 300
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT00503529
• Other Study ID Numbers: 690701; EUDRACT # 2007-000440-27
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ryszard Konior, MD; The John Paul II Hospital, Krakow, Poland

• PRS Account: Pfizer
• Verification Date: May 2015