Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects

Aim: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Methods: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vacc...

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Main Authors: Nianmin Shi, Yibin Zhang, Huizhen Zheng, Zhenggang Zhu, Dingming Wang, Sihai Li, Yuhua Li, Liqing Yang, Junnan Zhang, Yunhua Bai, Qiang Lu, Zheng Zhang, Fengji Luo, Chun Yu, Li Li
Format: Article
Language:English
Published: Taylor & Francis Group 2017-06-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2017.1279770
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author Nianmin Shi
Yibin Zhang
Huizhen Zheng
Zhenggang Zhu
Dingming Wang
Sihai Li
Yuhua Li
Liqing Yang
Junnan Zhang
Yunhua Bai
Qiang Lu
Zheng Zhang
Fengji Luo
Chun Yu
Li Li
author_facet Nianmin Shi
Yibin Zhang
Huizhen Zheng
Zhenggang Zhu
Dingming Wang
Sihai Li
Yuhua Li
Liqing Yang
Junnan Zhang
Yunhua Bai
Qiang Lu
Zheng Zhang
Fengji Luo
Chun Yu
Li Li
author_sort Nianmin Shi
collection DOAJ
description Aim: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Methods: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). Results: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Conclusions: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.
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spelling doaj.art-1544210cc3924599b89071a0122229482023-09-25T11:02:54ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-06-011361338134510.1080/21645515.2017.12797701279770Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjectsNianmin Shi0Yibin Zhang1Huizhen Zheng2Zhenggang Zhu3Dingming Wang4Sihai Li5Yuhua Li6Liqing Yang7Junnan Zhang8Yunhua Bai9Qiang Lu10Zheng Zhang11Fengji Luo12Chun Yu13Li Li14Chaoyang District Center for Disease Control and PreventionLiaoning Chengda biological Limited by Share LtdGuangdong Provincial Center for Disease Control and PreventionWuhan City Center for Disease Control and PreventionGuizhou Provincial Center for Disease Control and PreventionHunan Provincial Center for Disease Control and PreventionNational Institutes for Food and Drug ControlChaoyang District Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionGuizhou Provincial Center for Disease Control and PreventionChaoyang District Center for Disease Control and PreventionAim: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Methods: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). Results: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Conclusions: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.http://dx.doi.org/10.1080/21645515.2017.1279770post-exposureprotective effectrabies vaccinesafetyimmunogenicity
spellingShingle Nianmin Shi
Yibin Zhang
Huizhen Zheng
Zhenggang Zhu
Dingming Wang
Sihai Li
Yuhua Li
Liqing Yang
Junnan Zhang
Yunhua Bai
Qiang Lu
Zheng Zhang
Fengji Luo
Chun Yu
Li Li
Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
Human Vaccines & Immunotherapeutics
post-exposure
protective effect
rabies vaccine
safety
immunogenicity
title Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
title_full Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
title_fullStr Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
title_full_unstemmed Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
title_short Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects
title_sort immunogenicity safety and antibody persistence of a purified vero cell cultured rabies vaccine speeda administered by the zagreb regimen or essen regimen in post exposure subjects
topic post-exposure
protective effect
rabies vaccine
safety
immunogenicity
url http://dx.doi.org/10.1080/21645515.2017.1279770
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