Single-visit, 4-site intradermal (ID) rabies vaccination induces robust immune responses 5 years after 1-week, 4-site ID primary post-exposure prophylaxis in the Philippines

被引:5
作者
Quiambao, Beatriz P. [1 ]
Ambas, Cristina [1 ]
Diego, Sherylle [1 ]
Castells, Valerie Bosch [2 ]
Korejwo, Joanna [2 ]
Petit, Celine [2 ]
Rasuli, Anvar [2 ]
Houillon, Guy [2 ]
机构
[1] Res Inst Trop Med, Alabang, Muntinlupa City, Philippines
[2] Sanofi Pasteur, 14 Espace Henry Vallee, F-69007 Lyon, France
关键词
Verorab (R); Purified Vero cell rabies vaccine; Rabies post-exposure prophylaxis; Intradermal regimen; Philippines; Five-year follow-up; IMMUNOGENICITY; REGIMEN;
D O I
10.1016/j.vaccine.2020.03.043
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: In a randomized controlled study (NCT01622062) a 1-week, 4-site intradermal (ID, 4-4-4-00) post-exposure prophylaxis (PEP) rabies vaccination regimen with purified Vero cell rabies vaccine (PVRV, Verorab (R), Sanofi Pasteur), either without (Group 1) or with (Group 2) purified equine rabies immunoglobulin (ERIG), patients in the Philippines achieved seroconversion rates at Day 14 that were non-inferior to that of the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with ERIG (Group 3). Presented here are the annual immunogenicity data up to five years after the last primary dose, and the immunogenicity and safety data following simulated PEP with single-visit, 4-site ID regimen. Methods: Rabies virus neutralizing antibodies (RVNA) were determined by rapid fluorescent focus inhibition test (RFFIT). Participants (n = 397) received simulated PEP vaccination ID at Year 5 and RVNAs were assessed at Day 11 post-vaccination. Results: Seroconversion rates (RVNA titres >= 0.5 IU/mL) during annual follow-up remained >95% in Group 1 and were relatively stable at 80-90% in Group 2, but decreased from 80% to 64% in Group 3. RVNA geometric mean titres (GMTs) in Group 1 were consistently higher than in the other two groups, and those in Group 3 were generally lower than in the other two groups. There was a clear anamnestic response to vaccination in all groups, with all participants achieving RVNA titres >= 0.5 IU/mL at Day 11 postsimulated PEP booster vaccination. There were no safety concerns raised during annual follow-up and with simulated post-exposure vaccination with PVRV. Conclusion: The shortened, 1-week, 4-site ID regimen with PVRV achieved persistently higher RVNA titres than the updated 2-site TRC regimen, and more participants remained seroprotected up to five years after the last dose of primary immunization. Simulated post-exposure with 4-site ID rapidly induced an anamnestic response indicative of robust protection. (C) 2020 Sanofi Pasteur. Published by Elsevier Ltd.
引用
收藏
页码:3740 / 3746
页数:7
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