The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine

Virus Diseases Clinical Trial

Official title:

Long Term Immunogenicity up to 15 Years After the First Booster Immunization With GSK Biologicals' Encepur Adults (Polygeline-free Tick-Borne Encephalitis Vaccine for Adults) in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294135
• Other study ID #: 205847
• Secondary ID: 2017-001356-59
• Status: Completed
• Phase: Phase 4
• Start date: October 5, 2017
• Est. completion date: October 25, 2021

Study information

• Verified date: September 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to continue the evaluation of antibody persistence through 11 to 15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will further investigate the booster response in subjects who will receive their second booster dose* in this study.

• Any booster given in this study will be the second that the subject has received (with regard to the follow-up of the previous study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria for all subjects:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject prior to performance of any study specific procedure.

• Subjects who have participated in study V48P7E2 (NCT01562444) and who received in the parent V48P7 study one of the following schedules: rapid, conventional, or accelerated conventional and a booster vaccination in study V48P7E1 (NCT00387634) or before study V48P7E1 (NCT00387634) (only rapid schedule).

Additional inclusion criteria for subjects who will need a second booster dose:

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female subjects of childbearing potential can receive the booster vaccine in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after booster administration.

Exclusion Criteria:

Each subject must not be:

• Unwilling or unable to give written informed consent to participate in the study.

• Perceived to be unreliable or unavailable to complete the study.

Each subject must not have:

• Clinical conditions representing a contraindication to blood draws.

• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

• Received an investigational or non-registered medicinal product within 30 days prior to informed consent.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

• Levels of NT<10 in V48P7E2 (NCT01562444) study.

• Previous vaccination against TBE or other Flavivirus diseases with other TBE and Flavivirus vaccines (e.g. Yellow fever vaccine, Dengue fever vaccine, Japanese encephalitis vaccine) before, during and after completion of the V48P7E2 (NCT01562444) and before starting TBEV POLYGELINE FREE-025 EXT 21 study.

• Primary immunization with TBE vaccine in the parent study V48P7 according to the modified conventional (MC) schedule.

• History of confirmed TBE infection.

• Known exposure to other Flaviviruses.

Each subject who will receive the second booster vaccination in this study additionally to the exclusion criteria above must not have:

• Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.

• Clinical conditions representing a contraindication to intramuscular vaccination.

• Progressive, unstable or uncontrolled clinical conditions.

• Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent. This will mean prednisone =20 mg/day (for adult subjects) or equivalent. Inhaled and topical steroids are allowed. Administration of antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to vaccination.

• Received immunoglobulins or any blood products within 180 days prior to vaccination.

• Administration of long-acting immune-modifying drugs at any time during the study period.

• Acute disease and/or fever at the day of booster vaccination.

• Expected general decrease in immune response.

• Organic brain disturbances, including seizure disorders.

• Progressive neurological disorders.

• Suffered febrile or afebrile convulsions.

• Serious chronic illness.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or chemically related substances.

• Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccines.

• Pregnant.

Related Conditions & MeSH terms

• Virus Diseases

Intervention

Biological:
• Encepur Adults
One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.

Locations

Country	Name	City	State
Czechia	GSK Investigational Site	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Beran J, Lattanzi M, Costantini M, Pammolli A, Galgani I. Sustained antibody persistence for at least 15 years after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules: Third 5-year follow-up. Vaccine. 2023 May 26;41(23):3518-3524. doi: 10.1016/j.vaccine.2023.04.061. Epub 2023 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11	Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.	At Year 11
Primary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12	Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.	At Year 12
Primary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13	Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.	At Year 13
Primary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14	Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.	At Year 14
Primary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15	Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.	At Year 15
Primary	Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11	Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (>=) 50 years and >= 60 years.	At Year 11
Primary	Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12	Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years.	At Year 12
Primary	Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13	Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years.	At Year 13
Primary	Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14	Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years.	At Year 14
Primary	Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15	Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years.	At Year 15
Secondary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group	Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 2 and >= 10 at 21 days after the booster vaccination.	At 21 days after the booster vaccination
Secondary	Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group	Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.	At 21 days after the booster vaccination
Secondary	Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group	Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.	At 21 days after the booster vaccination
Secondary	Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group	Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 10 from Year 1 to Year 15.	From Year 1 up to Year 15
Secondary	Number of Participants With Serious Adverse Events (SAEs)	SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.	From Day 0 to Day 21 after booster vaccination