Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine

Vaccine
Stefan HopfUrsula Wiedermann

Abstract

Evaluation of safety, immunogenicity and efficacy of vaccines during licensing studies is performed in relation to the selected vaccination route. For most adjuvanted vaccines, such as the TBE vaccine FSME-IMMUN, only intramuscular (i.m.) administration is licensed. Yet in certain situations, either because of medical indications, accidental application or due to a lack of sufficient muscular tissue, the vaccine might rather be applied subcutaneously (s.c.). With respect to the TBE vaccine there are currently however no data to support the use of the subcutaneous route of vaccination. In order to compare the reactogenicity and immune responsiveness upon i.m. and s.c. TBE vaccination 116 (58 females and 58 males) participants with a documented primary TBE vaccination course were randomized to receive either an i.m. or s.c. booster. Venous blood was collected before, 7 days, 1 month and 6 months after vaccination to determine antibody titer profiles. PBMC were isolated prior to and 7 days after booster to analyze lymphocyte subpopulations and cytokine production upon antigen restimulation. Subjects were monitored for the occurrence of side effects for 7 days post vaccination. Comparable levels of TBE specific neutralizing antibod...Continue Reading

Associated Clinical Trials

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Citations

Jun 29, 2017·PloS One·A Charlotte M T de WolfFemke Broere
Sep 30, 2020·Human Vaccines & Immunotherapeutics·Ian F Cook
Oct 21, 2018·Vaccines·Guangyu LiTian Wang
Jun 13, 2020·Frontiers in Immunology·Erika Garner-SpitzerUrsula Wiedermann

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