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

NCT03294135 | Completed Phase 4 Results

• 2 other identifiers: 2058472017-001356-59
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Virus Diseases

Keywords

Encepur; Adults; Long term immunogenicity; Tick-borne Encephalitis vaccine; Booster

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

  At 21 days after the booster vaccination

• Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group

  At 21 days after the booster vaccination

• Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group

  At 21 days after the booster vaccination

• 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

  From Year 1 up to Year 15

• Number of Participants With Serious Adverse Events (SAEs)

  From Day 0 to Day 21 after booster vaccination

Study Arms (3)

Conventional Group

EXPERIMENTAL

Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.

Biological: Encepur Adults

Accelerated/Rapid Group

EXPERIMENTAL

Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

Biological: Encepur Adults

Accelerated Conventional Group

EXPERIMENTAL

Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.

Biological: Encepur Adults

Interventions

Encepur Adults BIOLOGICAL

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.

Accelerated Conventional Group; Accelerated/Rapid Group; Conventional Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hradec Králové, 50002, Czechia

Location

Related 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.

  PMID: 37142462 BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: October 5, 2017
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: March 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)