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TBE Seropersistence up to 10 Years After First Booster in Adults

Primary Purpose

Tick-borne Encephalitis (TBE)

Status

Completed

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

FSME-IMMUN 0.5 ml

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis (TBE)

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who participated in the first and second precursor studies 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 first precursor study and did not receive a second booster vaccination in the second precursor study
blood was drawn after their first booster vaccination in the first precursor study

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 since their first booster vaccination with FSME-IMMUN 0.5ml
have a known or suspected problem with drug or alcohol abuse

Sites / Locations

Prywatny Gabinet Lekarski
"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Seropersistence evaluation + 2nd booster vaccination

Arm Description

Blood will be drawn to assess the seropersistence of TBE virus antibodies at 82, 94, 106 and 118 months after the first booster vaccination with FSME-IMMUN 0.5ml administered during the first precursor study. Timing of the second booster vaccination will depend on the level of serum TBE antibodies observed during the study. Blood will be drawn 21 - 35 days after vaccination to assess the booster response.

Outcomes

Primary Outcome Measures

Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Secondary Outcome Measures

Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT

Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT

Full Information

NCT ID

NCT01582698

First Posted

April 20, 2012

Last Updated

January 20, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01582698

Brief Title

TBE Seropersistence up to 10 Years After First Booster in Adults

Official Title

Open-label Phase 4 Study to Investigate the Seropersistence of Tick-borne Encephalitis (TBE) Virus Antibodies From 7 to 10 Years After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tick-borne Encephalitis (TBE)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Seropersistence evaluation + 2nd booster vaccination

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

FSME-IMMUN 0.5 ml

Intervention Description

Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.

Primary Outcome Measure Information:

Title

Time Frame

118 months

Secondary Outcome Measure Information:

Title

Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study

Time Frame

118 months

Title

Time Frame

118 months

Title

Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT

Time Frame

118 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who participated in the first and second precursor studies 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 first precursor study and did not receive a second booster vaccination in the second precursor study blood was drawn after their first booster vaccination in the first precursor study 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 since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Prywatny Gabinet Lekarski

City

Dębica

ZIP/Postal Code

39-200

Country

Poland

Facility Name

"John Paul II" Cracow Specialist Hospital, Department of Pediatric Neuroinfections and Neurology

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

28545923

Citation

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.

Results Reference

derived

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TBE Seropersistence up to 10 Years After First Booster in Adults

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