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

Encephalitis, Tick-Borne Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503529
• Other study ID #: 690701
• Secondary ID: EUDRACT # 2007-0
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2007
• Last updated: May 20, 2015
• Start date: July 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)

Locations

Country	Name	City	State
Poland	Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy	Debica
Poland	Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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)	No