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

NCT ID: NCT00503529

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-09-30

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.

Conditions

Encephalitis, Tick-Borne

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

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

Intervention Type: BIOLOGICAL

Other Intervention Names

FSME-IMMUN 0.5 ml

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryszard Konior, MD

Role: PRINCIPAL_INVESTIGATOR

The John Paul II Hospital, Krakow, Poland

Locations

Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy

Dębica, , Poland

Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji

Krakow, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 28545923 (View on PubMed)

Other Identifiers

EUDRACT # 2007-000440-27

Identifier Type: -

Identifier Source: secondary_id

690701

Identifier Type: -

Identifier Source: org_study_id