Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.

Human enterovirus 71 (EV71) is a significant cause of morbidity and mortality from Hand, Foot and Mouth Disease (HFMD) and neurological complications, particularly in young children in the Asia-Pacific region. There are no vaccines or antiviral therapies currently available for prevention or treatme...

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Main Authors: Shi-Hsia Hwa, Yock Ann Lee, Joseph N Brewoo, Charalambos D Partidos, Jorge E Osorio, Joseph D Santangelo
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2013-11-01
Series:PLoS Neglected Tropical Diseases
Online Access:https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0002538&type=printable
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author Shi-Hsia Hwa
Yock Ann Lee
Joseph N Brewoo
Charalambos D Partidos
Jorge E Osorio
Joseph D Santangelo
author_facet Shi-Hsia Hwa
Yock Ann Lee
Joseph N Brewoo
Charalambos D Partidos
Jorge E Osorio
Joseph D Santangelo
author_sort Shi-Hsia Hwa
collection DOAJ
description Human enterovirus 71 (EV71) is a significant cause of morbidity and mortality from Hand, Foot and Mouth Disease (HFMD) and neurological complications, particularly in young children in the Asia-Pacific region. There are no vaccines or antiviral therapies currently available for prevention or treatment of HFMD caused by EV71. Therefore, the development of therapeutic and preventive strategies against HFMD is of growing importance. We report the immunogenic and safety profile of inactivated, purified EV71 preparations formulated with aluminum hydroxide adjuvant in preclinical studies in mice and rabbits. In mice, the candidate vaccine formulations elicited high neutralizing antibody responses. A toxicology study of the vaccine formulations planned for human use performed in rabbits showed no vaccine-related pathological changes and all animals remained healthy. Based on these preclinical studies, Phase 1 clinical testing of the EV71 inactivated vaccine was initiated.
format Article
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institution Kabale University
issn 1935-2727
1935-2735
language English
publishDate 2013-11-01
publisher Public Library of Science (PLoS)
record_format Article
series PLoS Neglected Tropical Diseases
spelling doaj-art-eeb616478f0b4a30941c4fb365f20f6c2025-01-16T05:32:27ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352013-11-01711e253810.1371/journal.pntd.0002538Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.Shi-Hsia HwaYock Ann LeeJoseph N BrewooCharalambos D PartidosJorge E OsorioJoseph D SantangeloHuman enterovirus 71 (EV71) is a significant cause of morbidity and mortality from Hand, Foot and Mouth Disease (HFMD) and neurological complications, particularly in young children in the Asia-Pacific region. There are no vaccines or antiviral therapies currently available for prevention or treatment of HFMD caused by EV71. Therefore, the development of therapeutic and preventive strategies against HFMD is of growing importance. We report the immunogenic and safety profile of inactivated, purified EV71 preparations formulated with aluminum hydroxide adjuvant in preclinical studies in mice and rabbits. In mice, the candidate vaccine formulations elicited high neutralizing antibody responses. A toxicology study of the vaccine formulations planned for human use performed in rabbits showed no vaccine-related pathological changes and all animals remained healthy. Based on these preclinical studies, Phase 1 clinical testing of the EV71 inactivated vaccine was initiated.https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0002538&type=printable
spellingShingle Shi-Hsia Hwa
Yock Ann Lee
Joseph N Brewoo
Charalambos D Partidos
Jorge E Osorio
Joseph D Santangelo
Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
PLoS Neglected Tropical Diseases
title Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
title_full Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
title_fullStr Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
title_full_unstemmed Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
title_short Preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine.
title_sort preclinical evaluation of the immunogenicity and safety of an inactivated enterovirus 71 candidate vaccine
url https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0002538&type=printable
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AT charalambosdpartidos preclinicalevaluationoftheimmunogenicityandsafetyofaninactivatedenterovirus71candidatevaccine
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