Seropersistence and booster response following vaccination with FSME-IMMUN in children,adolescents, and young adults |
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| Affiliation: | 1. Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Austria;2. Private Practice, Wels, Austria;3. Private Practice, Kehl, Germany;4. Pfizer Inc., Collegeville, PA, USA;5. Pfizer Inc., Paris, France;6. Pfizer Inc., Vienna, Austria;1. Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, USA;2. Department of Epidemiology, Emory University, Atlanta, GA, USA;3. Centers for Disease Control and Prevention, Atlanta, GA, USA;1. Institute of Cytology and Genetics, Russian Academy of Sciences, Siberian Branch, 10 Lavrentyeva Ave., Novosibirsk 630090 Russia;2. Novosibirsk State University, 2 Pirogova str., Novosibirsk 630090 Russia;3. Institute of Internal and Preventive Medicine, 175/1 B. Bogatkova str., Novosibirsk 630089 Russia;1. Department of Neurology, University Hospital, Goethe University Frankfurt, Schleusenweg 2-16, 60528 Frankfurt am Main, Germany;2. Region Västra Götaland, Sahlgrenska University Hospital, Department of Infectious Diseases, Guldhedsgatan 10 A-B, 41346 Gothenburg, Sweden;3. Bundeswehr Institute of Microbiology, German Center of Infection Research (DZIF), Neuherbergstraße 11, 80937 Munich, Germany;4. Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, Guldhedsgatan 10 A-B, 41346 Gothenburg, Sweden;5. Department of Pediatric and Adolescent Medicine, Division for Neonatology, University Hospital, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany;6. Department of Obstetrics and Prenatal Medicine, University Hospital, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany;7. Institute of Clinical Virology, University Hospital, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany;8. Division of Neonatology, Queen Silvia Children´s Hospital, Sahlgrenska University Hospital, Rondvägen 10, 41650 Gothenburg, Sweden;1. Department of Hematology and Coagulation, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;2. Department of Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden;3. Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;4. Department of Hematology, Varberg Hospital, Varberg, Sweden;5. Department of Hematology, South Älvsborgs Hospital, Borås, Sweden;6. Department of Hematology, Uddevalla Hospital, Uddevalla, Sweden;7. Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Huddinge and Division of Hematology, Dept of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden |
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| Abstract: | BackgroundTick-borne encephalitis (TBE) is a viral disease that can have a severe clinical course and considerable long-term morbidity. As no curative treatment exists, vaccination is the primary means of prevention. Long-term antibody seropersistence 2–5 years after the 3-dose primary immunization and 3–10 years after first booster was evaluated, as well as booster responses in children, adolescents and young adults.MethodsSubjects who participated in these phase 4 prospective, open-label follow-up studies received all vaccinations with FSME-IMMUN. After 3-dose primary immunization, subjects were followed for 2–5 years. Overall, 205 out of 358 subjects (57%) received the first booster and 179 of these subjects (87%) enrolled in a further 10-year follow-up. Antibody seropersistence was assessed annually. Subjects with a TBE antibody titer below a pre-specified cut-off at the yearly blood draw received a booster. Seropositivity rates and geometric mean fold rises (GMFRs) were assessed.ResultsIn children who received their 3-dose primary immunization between 1 and 15 years of age, the seropositivity rate 5 years after the 3rd dose was 84.9% by NT and 72.0% by ELISA. One month post-first booster, all subjects were seropositive by NT and 98.5% by ELISA. Response to first booster by GMFR ranged from 3.7 to 11.4. At 5 years post-first booster, seropositivity was 99.4% by NT and 97.5% by ELISA, and at 10 years, was 90.3% by NT and 87.7% by ELISA. Although seropositivity rates differed between age groups, all subjects (100%) who received a second booster responded with a robust increase of TBEV antibodies.DiscussionLong-lasting seropersistence of TBEV antibodies after the 3-dose primary immunization and first booster was demonstrated as well as a competent immune memory response in those who received a first or second booster at any time during the 15-year follow-up. Therefore, an extension of FSME-IMMUN booster interval up to 10 years after the 3-dose primary immunization seems warranted.ClinicalTrials.gov Identifier: NCT00894686. |
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| Keywords: | TBE Tick-borne encephalitis Tick Encephalitis |
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