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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00503529
First received: July 17, 2007
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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.

Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

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 [ 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) ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503529

Locations
Poland
Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy
Debica, Poland, 33-200
Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji
Krakow, Poland, 31-202
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Ryszard Konior, MD The John Paul II Hospital, Krakow, Poland
  More Information

No publications provided

Responsible Party: Katrin Koelling-Schlebusch, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00503529     History of Changes
Other Study ID Numbers: 690701, EUDRACT # 2007-000440-27
Study First Received: July 17, 2007
Last Updated: December 16, 2010
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 23, 2014