Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial

Highlights ► HFMD outbreaks cause high mortality in mainland China since 2008. ► Enterovirus 71 (EV71) was associated with high-mortality HFMD outbreaks. ► EV71 vaccine will be the most effective measure to reduce morbidity and mortality. ► The Phase I clinical study evaluated safety and immunogenic...

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Veröffentlicht in:	Vaccine 2012-05, Vol.30 (22), p.3295-3303
Hauptverfasser:	Li, Yan-Ping, Liang, Zheng-Lun, Gao, Qiang, Huang, Li-Rong, Mao, Qun-Ying, Wen, Shu-Qun, Liu, Yan, Yin, Wei-Dong, Li, Rong-Cheng, Wang, Jun-Zhi
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult adults Allergy and Immunology Aluminum Antibodies Antibodies, Neutralizing - blood Antibodies, Viral - blood Antigens Child Child, Preschool Children Clinical trials Confidence intervals Double-Blind Method Drug dosages Drug-Related Side Effects and Adverse Reactions - epidemiology Enterovirus 71 Enterovirus A Enterovirus A, Human - immunology EV71 vaccine Female Healthy Volunteers Human enterovirus 71 Humans Immune response Immunization Immunogenicity Infant Infants Injections, Intramuscular intramuscular injection Male Middle Aged Mortality neutralizing antibodies Outbreaks Placebos - administration & dosage Safety seroprevalence Vaccination Vaccination - adverse effects Vaccination - methods Vaccines Viral Vaccines - administration & dosage Viral Vaccines - adverse effects Viral Vaccines - immunology volunteers Young Adult
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Beschreibung
Zusammenfassung:	Highlights ► HFMD outbreaks cause high mortality in mainland China since 2008. ► Enterovirus 71 (EV71) was associated with high-mortality HFMD outbreaks. ► EV71 vaccine will be the most effective measure to reduce morbidity and mortality. ► The Phase I clinical study evaluated safety and immunogenicity of EV71 vaccine. ► EV71 was well tolerated and highly immunogenic in healthy subjects.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2012.03.010