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Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine.
Vaccine. 2016 Apr 12; 34(17):2027-34.V

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 antibodies were induced after s.c. and i.m. vaccination. At the cellular level, IL-2, IFN gamma and IL-10 levels did not significantly differ using either route of vaccination and the distribution of T cell subsets was comparable along with a relative decrease of regulatory T-cells after both ways of administration. In contrast to the immunogenicity analyses, the data from safety diaries revealed a significantly higher rate of local, but not of systemic reactions after s.c. administration. In conclusion, this study demonstrates that both routes lead to comparable immune responses to the TBE antigen. The higher rate and intensity of local reactions, particularly among women, after s.c. vaccination however needs to be addressed during counseling.

Authors+Show Affiliations

Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria.Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria.Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria.Institute of Environmental Health, Medical University of Vienna, Vienna, Austria.Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: ursula.wiedermann@meduniwien.ac.at.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26768126

Citation

Hopf, Stefan, et al. "Comparable Immune Responsiveness but Increased Reactogenicity After Subcutaneous Versus Intramuscular Administration of Tick Borne Encephalitis (TBE) Vaccine." Vaccine, vol. 34, no. 17, 2016, pp. 2027-34.
Hopf S, Garner-Spitzer E, Hofer M, et al. Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine. Vaccine. 2016;34(17):2027-34.
Hopf, S., Garner-Spitzer, E., Hofer, M., Kundi, M., & Wiedermann, U. (2016). Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine. Vaccine, 34(17), 2027-34. https://doi.org/10.1016/j.vaccine.2015.12.057
Hopf S, et al. Comparable Immune Responsiveness but Increased Reactogenicity After Subcutaneous Versus Intramuscular Administration of Tick Borne Encephalitis (TBE) Vaccine. Vaccine. 2016 Apr 12;34(17):2027-34. PubMed PMID: 26768126.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine. AU - Hopf,Stefan, AU - Garner-Spitzer,Erika, AU - Hofer,Michael, AU - Kundi,Michael, AU - Wiedermann,Ursula, Y1 - 2016/01/06/ PY - 2015/08/19/received PY - 2015/11/26/revised PY - 2015/12/22/accepted PY - 2016/1/16/entrez PY - 2016/1/16/pubmed PY - 2016/10/13/medline KW - BMI KW - Cellular KW - Humeral KW - Immune response KW - Immunogenicity KW - Intramuscular KW - Local KW - Safety KW - Side effects KW - Subcutaneous KW - Systemic KW - TBE KW - Vaccination route KW - Vaccine SP - 2027 EP - 34 JF - Vaccine JO - Vaccine VL - 34 IS - 17 N2 - 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 antibodies were induced after s.c. and i.m. vaccination. At the cellular level, IL-2, IFN gamma and IL-10 levels did not significantly differ using either route of vaccination and the distribution of T cell subsets was comparable along with a relative decrease of regulatory T-cells after both ways of administration. In contrast to the immunogenicity analyses, the data from safety diaries revealed a significantly higher rate of local, but not of systemic reactions after s.c. administration. In conclusion, this study demonstrates that both routes lead to comparable immune responses to the TBE antigen. The higher rate and intensity of local reactions, particularly among women, after s.c. vaccination however needs to be addressed during counseling. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/26768126/Comparable_immune_responsiveness_but_increased_reactogenicity_after_subcutaneous_versus_intramuscular_administration_of_tick_borne_encephalitis__TBE__vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)01868-X DB - PRIME DP - Unbound Medicine ER -