Five accelerated schedules for the tick-borne encephalitis vaccine FSME-Immun® in last-minute travellers: an open-label, single-Centre, randomized controlled pilot trial.
J Travel Med
; 2023 Apr 19.
Article
em En
| MEDLINE
| ID: mdl-37074147
ABSTRACT
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, group 5 two ID doses at day 0 and day 14. The last dose(s) of the primary vaccination scheme were given after one year IM (1 dose) or ID (2 doses). TBE virus neutralizing antibodies were measured in a plaque reduction neutralization test (PRNT90 and 50) at day 0, 14, 21, 28, month 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 GMTs 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 to 0-38% of IM vaccinations, 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 preferable.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Idioma:
En
Revista:
J Travel Med
Assunto da revista:
DOENCAS TRANSMISSIVEIS
/
SAUDE PUBLICA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Bélgica