Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.

<h4>Background</h4>Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia. No effective EV71 vaccine is available. A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT01268787, aims to evaluate the safety,...

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Autores principales:	Ai-Hsiang Chou, Chia-Chyi Liu, Jui-Yuan Chang, Renee Jiang, Yi-Chin Hsieh, Amanda Tsao, Chien-Long Wu, Ju-Lan Huang, Chang-Phone Fung, Szu-Min Hsieh, Ya-Fang Wang, Jen-Ren Wang, Mei-Hua Hu, Jen-Ron Chiang, Ih-Jen Su, Pele Choi-Sing Chong
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/029ff0ba187d4cfbb57b9ff9cc475b54
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spelling	oai:doaj.org-article:029ff0ba187d4cfbb57b9ff9cc475b542021-11-18T08:45:18ZFormalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.1932-620310.1371/journal.pone.0079783https://doaj.org/article/029ff0ba187d4cfbb57b9ff9cc475b542013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24278177/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia. No effective EV71 vaccine is available. A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT01268787, aims to evaluate the safety, reactogenicity and immunogenicity of a formalin-inactivated EV71 vaccine candidate (EV71vac) at 5- and 10-µg doses. In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV71 and CVA16.<h4>Methods</h4>Sixty eligible healthy adults were recruited and vaccinated. Blood samples were obtained on day 0, 21 and 42 and tested against B1, B4, B5, C2, C4A, C4B and CVA16 for cross-neutralizing antibody responses.<h4>Results</h4>The immunogenicity of both 5- and 10- µg doses were found to be very similar. Approximately 45% of the participants had <8 pre-vaccination neutralization titers (Nt) against the B4 vaccine strain. After the first EV71vac immunization, 95% of vaccinees have >4-fold increase in Nt, but there was no further increase in Nt after the second dose. EV71vac induced very strong cross-neutralizing antibody responses in >85% of volunteers without pre-existing Nt against subgenotype B1, B5 and C4A. EV71vac elicited weak cross-neutralizing antibody responses (∼20% of participants) against a C4B and Coxsackie virus A16. Over 90% of vaccinated volunteers did not develop cross-neutralizing antibody responses (Nt<8) against a C2 strain. EV71vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV71 and/or CVA16.<h4>Conclusion</h4>EV71vac is efficient in eliciting cross-neutralizing antibody responses against EV71 subgenotypes B1, B4, B5, and C4A, and provides the rationale for its evaluation in phase II clinical trials.<h4>Trial registration</h4>ClinicalTrials.gov NCT01268787.Ai-Hsiang ChouChia-Chyi LiuJui-Yuan ChangRenee JiangYi-Chin HsiehAmanda TsaoChien-Long WuJu-Lan HuangChang-Phone FungSzu-Min HsiehYa-Fang WangJen-Ren WangMei-Hua HuJen-Ron ChiangIh-Jen SuPele Choi-Sing ChongPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 11, p e79783 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Ai-Hsiang Chou Chia-Chyi Liu Jui-Yuan Chang Renee Jiang Yi-Chin Hsieh Amanda Tsao Chien-Long Wu Ju-Lan Huang Chang-Phone Fung Szu-Min Hsieh Ya-Fang Wang Jen-Ren Wang Mei-Hua Hu Jen-Ron Chiang Ih-Jen Su Pele Choi-Sing Chong Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
description	<h4>Background</h4>Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia. No effective EV71 vaccine is available. A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT01268787, aims to evaluate the safety, reactogenicity and immunogenicity of a formalin-inactivated EV71 vaccine candidate (EV71vac) at 5- and 10-µg doses. In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV71 and CVA16.<h4>Methods</h4>Sixty eligible healthy adults were recruited and vaccinated. Blood samples were obtained on day 0, 21 and 42 and tested against B1, B4, B5, C2, C4A, C4B and CVA16 for cross-neutralizing antibody responses.<h4>Results</h4>The immunogenicity of both 5- and 10- µg doses were found to be very similar. Approximately 45% of the participants had <8 pre-vaccination neutralization titers (Nt) against the B4 vaccine strain. After the first EV71vac immunization, 95% of vaccinees have >4-fold increase in Nt, but there was no further increase in Nt after the second dose. EV71vac induced very strong cross-neutralizing antibody responses in >85% of volunteers without pre-existing Nt against subgenotype B1, B5 and C4A. EV71vac elicited weak cross-neutralizing antibody responses (∼20% of participants) against a C4B and Coxsackie virus A16. Over 90% of vaccinated volunteers did not develop cross-neutralizing antibody responses (Nt<8) against a C2 strain. EV71vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV71 and/or CVA16.<h4>Conclusion</h4>EV71vac is efficient in eliciting cross-neutralizing antibody responses against EV71 subgenotypes B1, B4, B5, and C4A, and provides the rationale for its evaluation in phase II clinical trials.<h4>Trial registration</h4>ClinicalTrials.gov NCT01268787.
format	article
author	Ai-Hsiang Chou Chia-Chyi Liu Jui-Yuan Chang Renee Jiang Yi-Chin Hsieh Amanda Tsao Chien-Long Wu Ju-Lan Huang Chang-Phone Fung Szu-Min Hsieh Ya-Fang Wang Jen-Ren Wang Mei-Hua Hu Jen-Ron Chiang Ih-Jen Su Pele Choi-Sing Chong
author_facet	Ai-Hsiang Chou Chia-Chyi Liu Jui-Yuan Chang Renee Jiang Yi-Chin Hsieh Amanda Tsao Chien-Long Wu Ju-Lan Huang Chang-Phone Fung Szu-Min Hsieh Ya-Fang Wang Jen-Ren Wang Mei-Hua Hu Jen-Ron Chiang Ih-Jen Su Pele Choi-Sing Chong
author_sort	Ai-Hsiang Chou
title	Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
title_short	Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
title_full	Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
title_fullStr	Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
title_full_unstemmed	Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.
title_sort	formalin-inactivated ev71 vaccine candidate induced cross-neutralizing antibody against subgenotypes b1, b4, b5 and c4a in adult volunteers.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/029ff0ba187d4cfbb57b9ff9cc475b54
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Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers.

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