دورية أكاديمية
Immunogenicity, long term protection and safety of subcutaneous administration of hepatitis A vaccine in patients with hemophilia and other bleeding disorders: A randomized study.
| العنوان: | Immunogenicity, long term protection and safety of subcutaneous administration of hepatitis A vaccine in patients with hemophilia and other bleeding disorders: A randomized study. |
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| المؤلفون: | Nakasone M; Unidade de Hematologia, Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Lopes MH; Departamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Sartori AMC; Departamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Sandoval EPN; Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Villaça PR; Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., D'Amico EA; Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Carneiro JDA; Unidade de Hematologia, Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. Electronic address: jorge.carneiro@hc.fm.usp.br. |
| المصدر: | Vaccine [Vaccine] 2020 May 27; Vol. 38 (26), pp. 4162-4166. Date of Electronic Publication: 2020 May 04. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Amsterdam, The Netherlands : Elsevier Science Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983- |
| مواضيع طبية MeSH: | Hemophilia A* , Hepatitis A Vaccines*/adverse effects, Adult ; Child ; Humans ; Immunogenicity, Vaccine ; Injections, Intramuscular ; Injections, Subcutaneous ; Vaccines, Inactivated |
| مستخلص: | Hepatitis A vaccine is recommended for all individuals with hemophilia, although patients with bleeding disorders should avoid intramuscular (IM) injections. To date, only few studies showed subcutaneous (SC) route immunogenicity is comparable with the IM route. Therefore, this randomized study compared immunogenicity, long term protection and safety of hepatitis A vaccine administered by SC route with the IM route in 78 children and adults with hemophilia and other bleeding disorders. Thirty-eight patients had serology performed after first vaccine dose, determining seroconversion rates of 83.3% and 90.0% for the SC and the IM group, respectively (p = 0.5). Median IgG CO/OD value for the SC group was almost the double compared with the IM group (4.4 vs 2.6, p = 0.2). After second vaccine dose, seroconversion rates for the SC group was 97.5% and for the IM group was 97.4% (p = 1.0). Of the two patients who did not have seroconversion, interval between vaccine dose and serology was only one and two days for the SC and the IM group, respectively and in the following routine antibody dosage they presented seroconversion (100% for both groups). Median IgG CO/OD value for the SC group was greater than the IM group (72.5 vs. 58.0, p = 0.2). In a median of nine years after second vaccine dose, median IgG S/CO value for the SC group was slightly greater than the IM group (7.6 vs. 7.4, p = 0.8). There were no serious adverse events in both groups. Five (12.5%) patients of the SC group and seven (18.4%) of the IM group presented adverse events (p = 0.5). Twice as many patients of the IM group had clotting factor concentrates need for adverse events (15.8% vs. 7.5%, p = 0.3). Therefore, hepatitis A vaccine administered subcutaneously is as immunogenic, long term protective and even safer than the intramuscular route. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2020 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Bleeding disorders; Hemophilia; Hepatitis A vaccine; Immunogenicity; Long term protection; Safety |
| المشرفين على المادة: | 0 (Hepatitis A Vaccines) 0 (Vaccines, Inactivated) |
| تواريخ الأحداث: | Date Created: 20200508 Date Completed: 20210315 Latest Revision: 20210315 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1016/j.vaccine.2020.04.040 |
| PMID: | 32376110 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1873-2518 |
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| DOI: | 10.1016/j.vaccine.2020.04.040 |