Tick-borne encephalitis vaccine (inactivated) suspension for injection 0.5ml pre-filled syringes

BACKGROUND: The purpose of this exploratory study was to evaluate different accelerated tick-borne encephalitis (TBE) vaccine schedules for last-minute travellers. METHODS: In a single-centre, open-label pilot study, 77 TBE-naïve Belgian soldiers were randomized to one of the following five schedules with FSME-Immun®: group 1 ('classical accelerated' schedule) received one intramuscular (IM) dose at Day 0 and Day 14, group 2 two IM doses at Day 0, group 3 two intradermal (ID) doses at Day 0, group 4 two ID doses at Day 0 and Day 7 and group 5 two ID doses at Day 0 and Day 14. The last dose(s) of the primary vaccination scheme were given after 1 year: IM (1 dose) or ID (2 doses). TBE virus neutralizing antibodies were measured in a plaque reduction neutralization test (PRNT90 and 50) at Days 0, 14, 21, 28, Months 3, 6, 12 and 12+21 days. Seropositivity was defined as neutralizing antibody titres ≥10. RESULTS: The median age was 19-19.5 years in each group.Median time to seropositivity up to Day 28 was shortest for PRNT90 in ID-group 4 and for PRNT50 in all ID groups. Seroconversion until Day 28 peaked highest for PRNT90 in ID-group 4 (79%) and for PRNT50 in ID-groups 4 and 5 (both 100%). Seropositivity after the last vaccination after 12 months was high in all groups. Previous yellow fever vaccination was reported in 16% and associated with lower geometric mean titres of TBE-specific antibodies at all-time points.The vaccine was generally well tolerated. However, mild to moderate local reactions occurred in 73-100% of ID compared with 0-38% of IM vaccinations, and persistent discolouration was observed in nine ID vaccinated individuals. CONCLUSION: The accelerated two-visit ID schedules might offer a better immunological alternative to the recommended classical accelerated IM schedule, but an aluminium-free vaccine would be preferable.

Abstract licence: CC BY-NC

The incidence of Tick-borne encephalitis (TBE) cases has increased. The presumed location of transmission of Tick-borne encephalitis virus (TBEV) has been expanding increasingly in the western parts of Europe during the past decade. There has also been an increased incidence of surveillance-reported TBE cases in southern Sweden and southern Norway. Additionally, the warmer climate has enabled ticks to be present to a greater extent in the northern part of Scandinavia. In several reports, pre-school children tend to have a lower TBE incidence rate compared to teenagers, whereas both younger children and teenagers may experience severe neurological symptoms such as meningitis and encephalitis. In addition to physical impairments, long-term cognitive and mental impairments have been observed in up to 70% of children with TBEV infection. These may include attention deficits, reduced concentration and impaired memory, which can significantly affect daily life and school performance. Finland, Latvia and Slovenia have already included TBE vaccines in their National Immunisation Program (NIP). TBE vaccines are safe and effective for children from the age of 1, and we propose all countries with endemic areas include TBE vaccines in their future NIP. This is a cost-effective strategy and, even more important, a pivotal equity strategy for all European children.

Abstract licence: CC BY-NC-ND

INTRODUCTION: Tick-borne encephalitis (TBE), which is endemic across large regions of Europe and Asia, is most effectively prevented through vaccination. Three-dose primary TBE vaccination schedules are either rapid (0,7,21-days) or conventional (0,28-84-days, 9-12-months). The second dose can also be administered at 14 days for faster priming and sero-protection). Areas covered: We used a three-step selection process to identify 21 publications comparing the immunogenicity and/or safety of different schedules. Expert commentary: Priming with two or three TBE vaccine doses was highly immunogenic. After conventional priming (0-28 days), 95% adults and ≥95% children had neutralization test (NT) titers ≥10 at 14 days post-dose-2 compared with 92% adults and 99% children at 21 days post-dose-3 (rapid schedule). Most subjects retained NT titers ≥10 at day 300. A single booster dose induced a strong immune response in all subjects irrespective of primary vaccination schedule or elapsed time since priming. GMT peaked at 42 days post-dose-1 (i.e., 21 days post-dose 3 [rapid-schedule], or 14-28 days post-dose-2 [conventional-schedule]), and declined thereafter. Adverse events were generally rare and declined with increasing doses. In the absence of data to recommend one particular schedule, the regimen choice will remain at the physician's discretion, based on patient constraints and availability.

Abstract licence: CC BY-NC-ND

BACKGROUND: Southern Sweden is endemic for tick-borne encephalitis (TBE), with Stockholm County as one of the high-risk areas. Our aim in this study was to describe cases of vaccine failures and to optimize future vaccination recommendations. METHODS: Patients with TBE were identified in the notification database at the Department of Communicable Disease Control and Prevention in Stockholm County during 2006-2015. Vaccine failure was defined as TBE despite adherence to the recommended vaccination schedule with at least 2 doses. Clinical data were extracted from medical records. RESULTS: A total of 1004 TBE cases were identified, 53 (5%) were defined as vaccine failures. In this latter group, the median age was 62 years (6-83). Forty-three (81%) patients were aged >50 years and 2 were children. Approximately half of the patients had comorbidities, with diseases affecting the immune system accounting for 26% of all cases. Vaccine failures following the third or fourth vaccine dose accounted for 36 (68%) of the patients. Severe and moderate TBE disease affected 81% of the cases. CONCLUSIONS: To our knowledge, this is the largest documented cohort of TBE vaccine failures. Vaccine failure after 5 TBE vaccine doses is rare. Our data provide rationale for adding an extra priming dose to those aged ≥50 years.

Abstract licence: CC BY

Tick-borne encephalitis (TBE) is an increasing health threat in Sweden and elsewhere in Europe. TBE vaccination is commonly recommended in Sweden, but limited data are available on uptake, effectiveness, and impact of TBE vaccination. General population surveys conducted in 2019-2022 were used to estimated TBE vaccine uptake. TBE vaccine effectiveness (VE) was estimated using the screening method utilizing the surveys and public health TBE surveillance data, which predominately includes hospitalized TBE cases, from 2018 to 2022. Impact of TBE vaccination was calculated based on disease incidence and observed VE. In 2018-2022, 2,015 TBE cases were reported in Sweden; 82.8% (1,564/1,890) of cases with known TBE vaccination history were unvaccinated. Among persons surveyed from the general population with known vaccination history, 52.0% (11,562/22,247) were unvaccinated. Three dose VE against TBE was 89.0% (95% confidence interval 84.3-92.4). When stratified by age group, VE was 86.0% (55.7-95.6) in 1-15 years-of-age and 93.8% (87.5-96.9) in 16-49 years-of-age. In a conservative estimate, despite suboptimal compliance with TBE vaccination recommendations, vaccination averted an estimated thousand TBE cases, most resulting in hospitalization, in Sweden from 2018 to 2022. To prevent additional TBE cases in Sweden, enhanced efforts to increase TBE vaccine uptake and compliance to the TBE vaccination schedule are needed.

Abstract licence: CC BY-NC-ND