학술논문
Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial.
Document Type
Academic Journal
Author
Garcia Garrido HM; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.; van Put B; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.; Terryn S; Sciensano, Brussels 1050, Belgium.; de Pijper CA; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.; Stijnis C; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.; D'Haens GR; Amsterdam UMC, Department of Gastroenterology, University of Amsterdam, Amsterdam 1081 HZ, The Netherlands.; Spuls PI; Amsterdam UMC, Department of Dermatology, University of Amsterdam, Amsterdam 1081 HZ, The Netherlands.; van de Sande MG; Amsterdam UMC, Department of Rheumatology and Clinical Immunology, University of Amsterdam, Amsterdam 1081 HZ, The Netherlands.; van Gucht S; Sciensano, Brussels 1050, Belgium.; Grobusch MP; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.; Goorhuis A; Amsterdam UMC, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam 1081 HZ, The Netherlands.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 9434456 Publication Model: Print Cited Medium: Internet ISSN: 1708-8305 (Electronic) Linking ISSN: 11951982 NLM ISO Abbreviation: J Travel Med Subsets: MEDLINE
Subject
Language
English
Abstract
Background: For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods: In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21-28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21-28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results: We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83-9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21-28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0-6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion: In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.
(© International Society of Travel Medicine 2022. Published by Oxford University Press.)
Methods: In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21-28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21-28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results: We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83-9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21-28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0-6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion: In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.
(© International Society of Travel Medicine 2022. Published by Oxford University Press.)