- Email: [email protected]
Tick-borne encephalitis virus vaccine as additional alternative neoantigen for the clinical immunologist's toolbox
CORRESPONDENCE 617
J ALLERGY CLIN IMMUNOL VOLUME 131, NUMBER 2
2. Carroll KN, Gebretsadik T, Minton P, Woodward K, Liu Z, Miller EK, et al. Influence of maternal asthma on the cause and severity of infant acute respiratory tract infections. J Allergy Clin Immunol 2012;129:1236-42. Available online December 28, 2012. http://dx.doi.org/10.1016/j.jaci.2012.11.026
Tick-borne encephalitis virus vaccine as additional alternative neoantigen for the clinical immunologist’s toolbox To the Editor: Diagnostic immunization of potentially immunodeficient patients and response evaluation by means of laboratory results belong to the standard ‘‘clinical allergist/immunologist’s toolbox,’’ as stated by Orange et al1 recently. However, its management and respective interpretation continue to challenge the physicians’ responsibility, considering ethical regulations and the individual immunologic knowledge and experience. Thus, clinical pediatric and adult immunologists will highly appreciate the recently published working group report on the ‘‘Use and interpretation of diagnostic vaccination in primary immunodeficiency’’ of the American Academy of Allergy, Asthma & Immunology,1 because it represents an official document with evidence-supported guidelines for these ‘‘standard off-label’’ practices. From the European point of view, we suggest to additionally take advantage of the possibility to use the protein neoantigen tick-borne encephalitis virus (TBEV) vaccine as a diagnostic tool to test B-cell function, which we showed to be safe and feasible in immunodeficient patients under regular IgG substitution therapy.2 For this application, it is advisable to quantity the patient’s anti-TBEV antibody concentration before starting the vaccination and not to change the batch (and thereby potentially the geographic source) of intravenous or subcutaneous IgG (IVIG/SCIG) preparation until response evaluation, or, ideally, to use IVIG/SCIG with no TBEV-neutralizing antibody capacity, that is, US–plasma-derived IVIG,3 to obtain most accurate test results. TBEV vaccines are licensed and easily available in most European countries, and routine laboratory tests to quantify the vaccine response exist. Because the tolerability and safety of a diagnostically administered neoantigen/vaccine is regarded to be of outmost importance, and a potential benefit through immunization against a prevalent virus might increase the patient’s cooperativity, a well-tolerated TBEV vaccine4 represents a very good alternative to evaluate humoral immune function, in addition to the recommended vaccinations1 with either rabies virus vaccine or the nonlicensed artificial antigens bacteriophage 4X174 and keyhole limpet hemocyanin (with rarely available readout tests) as described in section IV of the working group report.1 Markus G. Seidel, MDa Christina B. Planitzer, PhDb Thomas R. Kreil, PhDb Elisabeth F€ orster-Waldl, MDc From athe Department of Pediatrics and Adolescent Medicine, Division of Pediatric Hematology-Oncology, Medical University of Graz, Austria; bGlobal Pathogen Safety, Baxter BioScience Innovations, Vienna, Austria; and cthe Department of Paediatrics and Adolescent Medicine, Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Medical University Vienna, Austria. E-mail: markus. [email protected], [email protected]. Disclosure of potential conflict of interest: C. B. Planitzer is employed by Baxter BioScience. T. R. Kreil is employed by and has stock/stock options in Baxter
Innovations. E. F€orster-Waldl has received research support from the Austrian Science Fund and the Austrian National Bank and has received lecture fees and travel support from Paracelsus Medical University Salzburg, CSL Behring, Octapharma, and Pfizer. The rest of the authors declare that they have no relevant conflicts of interest. REFERENCES 1. Orange JS, Ballow M, Stiehm ER, Ballas ZK, Chinen J, De La Morena M, et al. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol 2012; 130:S1-24. 2. Seidel MG, Grohmann E, Sadeghi K, Pollak A, Heitger A, F€orster-Waldl E. Vaccination against tick-borne encephalitis virus tests specific IgG production ability in patients under immunoglobulin substitution therapy. Vaccine 2010; 28:6621-6. 3. Rabel PO, Planitzer CB, Farcet MR, Kreil TR. Tick-borne encephalitis virusneutralizing antibodies in different immunoglobulin preparations. Clin Vaccine Immunol 2012;19:623-5. 4. Barrett PN, Schober-Bendixen S, Ehrlich HJ. History of TBE vaccines. Vaccine 2003;21:S41-9. Available online December 28, 2012. http://dx.doi.org/10.1016/j.jaci.2012.11.029
Reply To the Editor: We are grateful for the comment of Seidel et al1 and that the AAAAI Work Group Report ‘‘Use and interpretation of diagnostic vaccination in primary immunodeficiency’’2 is of perceived value to our colleagues in Europe. We also appreciate their recent work regarding the use of tick-borne encephalitis (TBE) vaccine as a neoantigen in patients with primary immunodeficiency.3 TBE vaccination (TicoVac, Baxter, Berkshire, United Kingdom; FSME-IMMUN, Baxter, Vienna, Austria; or Encepur, Novartis, Basel, Switzerland) is of value in Europe as the disease is endemic in certain countries including China, Japan, and Russia.4 As the authors state, the US plasma pool is not believed to contain protective antibodies against TBE and thus the vaccine would qualify as a potentially valuable neoantigen in the United States. The TBE vaccine is not licensed by the US Food and Drug Administration, and thus it is presently not possible to provide it to patients in the United States. Given its utility and record in Europe, however, the application of TBE vaccine as a neoantigen in the United States is certainly worth studying. As stated in our document, the review of evidence and primary literature occurred between 2008 and 2009 and was completed by mid-2010.2 The work on TBE as a neoantigen was published thereafter and emphasizes the need for the timely development and publication of professional guidance statements as well as the need for them to exist as fluid documents to be built upon as additional evidence accumulates. Jordan S. Orange, MD, PhDa Rohit Katial, MDb From athe Section of Immunology Allergy and Rheumatology, Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Tex; and b National Jewish Health and the University of Colorado School of Medicine, Denver, Colo. E-mail: [email protected]. Disclosure of potential conflict of interest: J. S. Orange has received consultancy fees from Baxter Bioscience, Grifols, Octapharma USA, CSL Behring, IBT Reference Laboratories, and Cangene; has received lecture fees from Baxter Bioscience; and receives royalties from UpToDate. R. Katial declares that he has no relevant conflicts of interest.
J ALLERGY CLIN IMMUNOL VOLUME 131, NUMBER 2
2. Carroll KN, Gebretsadik T, Minton P, Woodward K, Liu Z, Miller EK, et al. Influence of maternal asthma on the cause and severity of infant acute respiratory tract infections. J Allergy Clin Immunol 2012;129:1236-42. Available online December 28, 2012. http://dx.doi.org/10.1016/j.jaci.2012.11.026
Tick-borne encephalitis virus vaccine as additional alternative neoantigen for the clinical immunologist’s toolbox To the Editor: Diagnostic immunization of potentially immunodeficient patients and response evaluation by means of laboratory results belong to the standard ‘‘clinical allergist/immunologist’s toolbox,’’ as stated by Orange et al1 recently. However, its management and respective interpretation continue to challenge the physicians’ responsibility, considering ethical regulations and the individual immunologic knowledge and experience. Thus, clinical pediatric and adult immunologists will highly appreciate the recently published working group report on the ‘‘Use and interpretation of diagnostic vaccination in primary immunodeficiency’’ of the American Academy of Allergy, Asthma & Immunology,1 because it represents an official document with evidence-supported guidelines for these ‘‘standard off-label’’ practices. From the European point of view, we suggest to additionally take advantage of the possibility to use the protein neoantigen tick-borne encephalitis virus (TBEV) vaccine as a diagnostic tool to test B-cell function, which we showed to be safe and feasible in immunodeficient patients under regular IgG substitution therapy.2 For this application, it is advisable to quantity the patient’s anti-TBEV antibody concentration before starting the vaccination and not to change the batch (and thereby potentially the geographic source) of intravenous or subcutaneous IgG (IVIG/SCIG) preparation until response evaluation, or, ideally, to use IVIG/SCIG with no TBEV-neutralizing antibody capacity, that is, US–plasma-derived IVIG,3 to obtain most accurate test results. TBEV vaccines are licensed and easily available in most European countries, and routine laboratory tests to quantify the vaccine response exist. Because the tolerability and safety of a diagnostically administered neoantigen/vaccine is regarded to be of outmost importance, and a potential benefit through immunization against a prevalent virus might increase the patient’s cooperativity, a well-tolerated TBEV vaccine4 represents a very good alternative to evaluate humoral immune function, in addition to the recommended vaccinations1 with either rabies virus vaccine or the nonlicensed artificial antigens bacteriophage 4X174 and keyhole limpet hemocyanin (with rarely available readout tests) as described in section IV of the working group report.1 Markus G. Seidel, MDa Christina B. Planitzer, PhDb Thomas R. Kreil, PhDb Elisabeth F€ orster-Waldl, MDc From athe Department of Pediatrics and Adolescent Medicine, Division of Pediatric Hematology-Oncology, Medical University of Graz, Austria; bGlobal Pathogen Safety, Baxter BioScience Innovations, Vienna, Austria; and cthe Department of Paediatrics and Adolescent Medicine, Division of Neonatology, Paediatric Intensive Care and Neuropaediatrics, Medical University Vienna, Austria. E-mail: markus. [email protected], [email protected]. Disclosure of potential conflict of interest: C. B. Planitzer is employed by Baxter BioScience. T. R. Kreil is employed by and has stock/stock options in Baxter
Innovations. E. F€orster-Waldl has received research support from the Austrian Science Fund and the Austrian National Bank and has received lecture fees and travel support from Paracelsus Medical University Salzburg, CSL Behring, Octapharma, and Pfizer. The rest of the authors declare that they have no relevant conflicts of interest. REFERENCES 1. Orange JS, Ballow M, Stiehm ER, Ballas ZK, Chinen J, De La Morena M, et al. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol 2012; 130:S1-24. 2. Seidel MG, Grohmann E, Sadeghi K, Pollak A, Heitger A, F€orster-Waldl E. Vaccination against tick-borne encephalitis virus tests specific IgG production ability in patients under immunoglobulin substitution therapy. Vaccine 2010; 28:6621-6. 3. Rabel PO, Planitzer CB, Farcet MR, Kreil TR. Tick-borne encephalitis virusneutralizing antibodies in different immunoglobulin preparations. Clin Vaccine Immunol 2012;19:623-5. 4. Barrett PN, Schober-Bendixen S, Ehrlich HJ. History of TBE vaccines. Vaccine 2003;21:S41-9. Available online December 28, 2012. http://dx.doi.org/10.1016/j.jaci.2012.11.029
Reply To the Editor: We are grateful for the comment of Seidel et al1 and that the AAAAI Work Group Report ‘‘Use and interpretation of diagnostic vaccination in primary immunodeficiency’’2 is of perceived value to our colleagues in Europe. We also appreciate their recent work regarding the use of tick-borne encephalitis (TBE) vaccine as a neoantigen in patients with primary immunodeficiency.3 TBE vaccination (TicoVac, Baxter, Berkshire, United Kingdom; FSME-IMMUN, Baxter, Vienna, Austria; or Encepur, Novartis, Basel, Switzerland) is of value in Europe as the disease is endemic in certain countries including China, Japan, and Russia.4 As the authors state, the US plasma pool is not believed to contain protective antibodies against TBE and thus the vaccine would qualify as a potentially valuable neoantigen in the United States. The TBE vaccine is not licensed by the US Food and Drug Administration, and thus it is presently not possible to provide it to patients in the United States. Given its utility and record in Europe, however, the application of TBE vaccine as a neoantigen in the United States is certainly worth studying. As stated in our document, the review of evidence and primary literature occurred between 2008 and 2009 and was completed by mid-2010.2 The work on TBE as a neoantigen was published thereafter and emphasizes the need for the timely development and publication of professional guidance statements as well as the need for them to exist as fluid documents to be built upon as additional evidence accumulates. Jordan S. Orange, MD, PhDa Rohit Katial, MDb From athe Section of Immunology Allergy and Rheumatology, Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Tex; and b National Jewish Health and the University of Colorado School of Medicine, Denver, Colo. E-mail: [email protected]. Disclosure of potential conflict of interest: J. S. Orange has received consultancy fees from Baxter Bioscience, Grifols, Octapharma USA, CSL Behring, IBT Reference Laboratories, and Cangene; has received lecture fees from Baxter Bioscience; and receives royalties from UpToDate. R. Katial declares that he has no relevant conflicts of interest.