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

NCT00503529 | Completed Phase 4 DMC

• 2 other identifiers: 690701EUDRACT # 2007-000440-27
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) BIOLOGICAL

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

Also known as: FSME-IMMUN 0.5 ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy

Dębica, 33-200, Poland

Location

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

Krakow, 31-202, Poland

Location

Related Publications (1)

• 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.

  PMID: 28545923 DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ryszard Konior, MD

  The John Paul II Hospital, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

PL (2)