Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial

@article{Zhu2013ImmunogenicityAS,
  title={Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial},
  author={Fengcai Zhu and Zheng-lun Liang and Xiu-ling Li and Heng-Ming Ge and Fan-Yue Meng and Qunying Mao and Yun-tao Zhang and Yuemei Hu and Zhen-Yu Zhang and Jing-xin Li and Fan Gao and Qing-Hua Chen and Qi-Yan Zhu and Kai Chu and Xing Wu and Xin Yao and Hui jie Guo and Xiao-qin Chen and Pei Liu and Yu-ying Dong and Feng-xiang Li and Xin-liang Shen and Jun-Zhi Wang},
  journal={The Lancet},
  year={2013},
  volume={381},
  pages={1037-1045}
}
BACKGROUND Enterovirus 71 (EV71) outbreaks are a socioeconomic burden, especially in the western Pacific region. Results of phase 1 clinical trials suggest an EV71 vaccine has a clinically acceptable safety profile and immunogenicity. We aimed to assess the best possible dose and formulation, immunogenicity, and safety profile of this EV71 vaccine in healthy Chinese children. METHODS This randomised, double-blind, placebo-controlled, phase 2 trial was undertaken at one site in Donghai County… Expand
Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
TLDR
Evaluating the efficacy, safety, immunogenicity, antibody persistence, and immunological correlates of an inactivated alum-adjuvant EV71 vaccine in healthy children from four centres in China found it provides high efficacy, satisfactory safety, and sustained Immunogenicity. Expand
A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial.
TLDR
A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Expand
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TLDR
The 400 U dose was recommended as the optimal dose for the phase III trial because of its good safety profile and higher immunogenicity, and the dose-response relationship remained until 13 months after the second vaccination, despite waning antibody levels. Expand
Immunogenicity, Safety, and Lot Consistency of a Novel Inactivated Enterovirus 71 Vaccine in Chinese Children Aged 6 to 59 Months
  • Yue-Mei Hu, Xu Wang, +12 authors Jiang-Ting Chen
  • Medicine
  • Clinical and Vaccine Immunology
  • 2013
TLDR
The demonstration of consistency between the manufacturing lots confirms for the purposes of clinical development the reliability of the EV71 vaccine production process. Expand
2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study
TLDR
Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children, and no vaccine-related serious adverse events were recorded. Expand
Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial
TLDR
The results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile. Expand
Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinical trial
TLDR
Ev71 vaccine was highly immunogenic in children, and the 3 consecutive batches were well consistent, and no differences were found among 3 vaccine batches and placebos. Expand
Effectiveness of EV-A71 vaccination in prevention of paediatric hand, foot, and mouth disease associated with EV-A71 virus infection requiring hospitalisation in Henan, China, 2017-18: a test-negative case-control study.
TLDR
Evaluated monovalent enterovirus A71 vaccination was effective in preventing non-severe hand, foot, and mouth disease associated with EV-A71 virus infection in children aged 6-71 months, and there is evidence that one dose of vaccination provided partial protection for children aged 24- 71 months. Expand
Update on the development of enterovirus 71 vaccines
TLDR
Although inactivated EV71 vaccines are safe, efficient and elicit strong immune responses to protect adults, children and infants against infection, the quality control of production is critical. Expand
The compatibility of inactivated-Enterovirus 71 vaccination with Coxsackievirus A16 and Poliovirus immunizations in humans and animals
TLDR
Research showed that inactivated-EV71 vaccine has good specific-neutralizing capacity and can be included in EPI, and there was no NTAb cross-activity between EV71 and CA16/Poliovirus. Expand
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TLDR
The novel human EV71 inactivated vaccine was well tolerated and highly immunogenic in healthy volunteers, especially in infant populations, and for immune response, the seropositive rates of neutralizing antibody increased to 100% for all dosage groups after the second vaccination. Expand
Reactogenicity and Immunogenicity of an Enterovirus 71 Vaccine in Chinese Healthy Children and Infants
TLDR
This study found that the inactivated EV71 vaccine was well tolerated and had good immunogenicity in healthy children and infants. Expand
Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children
TLDR
In the according-to-protocol cohort for immunogenicity, it was observed one dose of EV71 vaccine elicited good immune response in the participants, especially for the ones with sero-positive baseline, and no obvious dose-response relationship for Immunogenicity was found. Expand
Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial.
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IPV alone and IPV followed by OPV are safe and effective for Guatemalan infants and maternal antibodies lowered the final antibody responses to IPV but did not prevent the development of protective levels of antibody. Expand
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TLDR
A antigen reference standard based on the C4 subtype of the EV71 vaccine strain was developed and national NTAb reference panels were found to effectively reduce assay discrepancy between different labs, which are highly valuable for the standardization and evaluation of EV71 vaccines. Expand
Formaldehyde-inactivated human enterovirus 71 vaccine is compatible for co-immunization with a commercial pentavalent vaccine.
TLDR
Results indicate that formaldehyde-inactivated whole virus EV71 vaccine is feasible for designing multivalent vaccines. Expand
Dynamic change of mother-source neutralizing antibodies against enterovirus 71 and coxsackievirus A16 in infants.
TLDR
The prevalence of EV71 and Cox A16 were relatively high in Jiangsu Province, China, and the ideal time point for prime immunization for infants is around 2-5 months of age, suggesting no maternal antibody may remain in infants at seven months. Expand
Antigenicity, animal protective effect and genetic characteristics of candidate vaccine strains of enterovirus 71
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Compared the antigenicity and genetic characteristics of different candidate vaccine strains for EV71, the genomes of 11 EV71 strains were sequenced and showed that vaccine strains with good cross-neutralization capacities had the potential to be vaccine strains. Expand
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Clinical experiences with IPV administration and outcomes in various countries in Europe, the Americas, Africa and Asia are reviewed, demonstrating the ability of IPV to prevent poliovirus outbreaks and provide herd protection. Expand
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