Rudolf Schosser1, Anja Reichert2, Ulrich Mansmann3, Bernd Unger4, Ulrich Heininger5, Reinhard Kaiser6. 1. Medical Affairs, Baxter Deutschland GmbH, Im Breitspiel 13, 69126 Heidelberg, Germany. 2. Medical Affairs Group DACH, Baxter Deutschland GmbH, Edisonstrasse 4, 85716 Unterschleißheim, Germany. Electronic address: anja_reichert@baxter.com. 3. Institute of Medical Informatics, Biometry, and Epidemiology, Faculty of Medicine, University of Munich, Marchioninistrasse 15, 81377 München, Germany. 4. Global R&D, Baxter Bioscience, IZD Tower, Wagramer Strasse 17-19, 1220 Wien, Austria. 5. Division of Paediatric Infectious Diseases and Vaccinology, University Children's Hospital, Spitalstrasse 33, 4031 Basel, Switzerland. 6. Neurological Clinic, Klinikum Pforzheim GmbH, Kanzlerstrasse 2-6, 75175 Pforzheim, Germany.
Abstract
BACKGROUND: Intervals longer than recommended are frequently encountered between doses of tick borne encephalitis virus (TBE) vaccines in both residents of and travelers to endemic regions. In clinical practice the management of individuals with lapsed TBE vaccination schedules varies widely and has in common that the underlying immunological evidence is scarce. STUDY PURPOSE AND METHODS: The aim of this study was to generate data reliable enough to derive practical recommendations on how to continue vaccination with FSME-IMMUN in subjects with an irregular TBE vaccination history. Antibody response to a single catch-up dose of FSME-IMMUN was assessed in 1115 adults (age ≥16 years) and 125 children (age 6-15 years) with irregular TBE vaccination histories. RESULTS: Subjects of all age groups developed a substantial increase in geometric mean antibody concentration after a single catch-up TBE vaccination which was consistently lower in subjects with only one previous TBE vaccination compared to subjects with two or more vaccinations. Overall, >94% of young adults and children, and >93% of elderly subjects with an irregular TBE vaccination history achieved antibody levels ≥25U/ml irrespective of the number of previous TBE vaccinations. CONCLUSION: We conclude that TBE vaccination of subjects with irregular vaccination histories should be continued as if the previous vaccinations had been administered in a regular manner, with the stage of the vaccination schedule being determined by the number of previous vaccinations. Although lapsed vaccination schedules may leave subjects temporarily with inadequate protection against TBE infection, adequate protection can quickly be re-established in >93% of the subjects by a single catch-up dose of FSME-IMMUN, irrespective of age, number of previous vaccinations, and time interval since the last vaccination.
BACKGROUND: Intervals longer than recommended are frequently encountered between doses of tick borne encephalitis virus (TBE) vaccines in both residents of and travelers to endemic regions. In clinical practice the management of individuals with lapsed TBE vaccination schedules varies widely and has in common that the underlying immunological evidence is scarce. STUDY PURPOSE AND METHODS: The aim of this study was to generate data reliable enough to derive practical recommendations on how to continue vaccination with FSME-IMMUN in subjects with an irregular TBE vaccination history. Antibody response to a single catch-up dose of FSME-IMMUN was assessed in 1115 adults (age ≥16 years) and 125 children (age 6-15 years) with irregular TBE vaccination histories. RESULTS: Subjects of all age groups developed a substantial increase in geometric mean antibody concentration after a single catch-up TBE vaccination which was consistently lower in subjects with only one previous TBE vaccination compared to subjects with two or more vaccinations. Overall, >94% of young adults and children, and >93% of elderly subjects with an irregular TBE vaccination history achieved antibody levels ≥25U/ml irrespective of the number of previous TBE vaccinations. CONCLUSION: We conclude that TBE vaccination of subjects with irregular vaccination histories should be continued as if the previous vaccinations had been administered in a regular manner, with the stage of the vaccination schedule being determined by the number of previous vaccinations. Although lapsed vaccination schedules may leave subjects temporarily with inadequate protection against TBE infection, adequate protection can quickly be re-established in >93% of the subjects by a single catch-up dose of FSME-IMMUN, irrespective of age, number of previous vaccinations, and time interval since the last vaccination.
Authors: Lidia Chitimia-Dobler; Alexander Lindau; Rainer Oehme; Malena Bestehorn-Willmann; Markus Antwerpen; Marco Drehmann; Thomas Hierl; Ute Mackenstedt; Gerhard Dobler Journal: Microorganisms Date: 2021-04-21