Enterovirus 71 vaccine acceptance among parents of children < 5 years old and their knowledge of hand, foot and mouth disease, Chongqing, China, 2017

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Abstract

Background

Enterovirus 71 (EV71) vaccine, which was put into market in China in 2016, has been viewed as a promising prevention measure against severe and fatal hand, foot and mouth disease (HFMD). This study aimed to investigate the knowledge of HFMD and acceptability of EV71 vaccine among parents of under-five in Chongqing, China.

Methodology /Principal findings

A cross-sectional survey was conducted in 2017. A validated questionnaire consisting of three sections including demographic information, knowledge of HFMD, acceptability and reasons for declining vaccination was developed based on literature review. Factors associated with unwillingness to receive EV71 vaccine were explored using multivariate logistic regression. A total of 992 parents finished the questionnaire with a response rate of 91.9%. Awareness of HFMD and EV71 vaccine were reported by 823 (83.0%) parents and 386 (38.9%) parents respectively. Knowledge about HFMD was with a mean score of 5.0 (standard deviation = 3.5) out of a total score of 12. Only 369 (37.2%) participants were classified as with good knowledge level about HFMD. 279 (28.1%) participants had their children received EV71 vaccine and 271 (27.3%) expressed willingness to vaccinate their children after a short-time education about EV71 vaccine. Acceptability of EV71 vaccine increased along with parents’ education level ( p = 0.008) and HFMD knowledge level (p<0.001). Parents of scattered children had higher acceptability than those of preschool children ( p = 0.002). 442 (44.6%) of participants were unwilling to have their children vaccinated with EV71 vaccine. The most common reasons for declining EV71 vaccine were doubts about its safety (56.6%) and efficacy (48.3%), and the necessity of vaccination (38.3%). Physicians and vaccination certificate were the parents’ most trusted sources of vaccine information.

Conclusions

Parents’ knowledge about HFMD was not sufficient, and nearly half of the parents expressed unwillingness to vaccinate their children with EV71 vaccine. Our findings stress that more efforts by health authorities in Chongqing are needed to increase the acceptability of EV71 vaccine, especially among parents of preschool children with lower education level.

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Most cited references 22

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Clinical features, diagnosis, and management of enterovirus 71.

Mong How Ooi, See Chang Wong, Penny Lewthwaite … (2010)

Although poliomyelitis has been mostly eradicated worldwide, large outbreaks of the related enterovirus 71 have been seen in Asia-Pacific countries in the past 10 years. This virus mostly affects children, manifesting as hand, foot, and mouth disease, aseptic meningitis, poliomyelitis-like acute flaccid paralysis, brainstem encephalitis, and other severe systemic disorders, including especially pulmonary oedema and cardiorespiratory collapse. Clinical predictors of severe disease include high temperature and lethargy, and lumbar puncture might reveal pleocytosis. Many diagnostic tests are available, but PCR of throat swabs and vesicle fluid, if available, is among the most efficient. Features of inflammation, particularly in the anterior horns of the spinal cord, the dorsal pons, and the medulla can be clearly seen on MRI. No established antiviral treatment is available. Intravenous immunoglobulin seems to be beneficial in severe disease, perhaps through non-specific anti-inflammatory mechanisms, but has not been tested in any formal trials. Milrinone might be helpful in patients with cardiac dysfunction. Copyright © 2010 Elsevier Ltd. All rights reserved.

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Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.

Xiaojuan Tan, Y. Hu, MingLei Zhang … (2014)

Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients (13 of 5041 children) and 2.1% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100% (95% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2%) and 131 of 5033 children in the placebo group (2.6%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).

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An inactivated enterovirus 71 vaccine in healthy children.

Qunying Mao, Lichun Wang, Zhenglun Liang … (2014)

Enterovirus 71 (EV71) is a major cause of hand, foot, and mouth disease in children and may be fatal. A vaccine against EV71 is needed. We conducted a randomized, double-blind, placebo-controlled phase 3 trial involving healthy children 6 to 71 months of age in Guangxi Zhuang Autonomous Region, China. Two doses of an inactivated EV71 vaccine or placebo were administered intramuscularly, with a 4-week interval between doses, and children were monitored for up to 11 months. The primary end point was protection against hand, foot, and mouth disease caused by EV71. A total of 12,000 children were randomly assigned to receive vaccine or placebo. Serum neutralizing antibodies were assessed in 549 children who received the vaccine. The seroconversion rate was 100% 4 weeks after the two vaccinations, with a geometric mean titer of 170.6. Over the course of two epidemic seasons, the vaccine efficacy was 97.4% (95% confidence interval [CI], 92.9 to 99.0) according to the intention-to-treat analysis and 97.3% (95% CI, 92.6 to 99.0) according to the per-protocol analysis. Adverse events, such as fever (which occurred in 41.6% of the participants who received vaccine vs. 35.2% of those who received placebo), were significantly more common in the week after vaccination among children who received the vaccine than among those who received placebo. The inactivated EV71 vaccine elicited EV71-specific immune responses and protection against EV71-associated hand, foot, and mouth disease. (Funded by the National Basic Research Program and others; ClinicalTrials.gov number, NCT01569581.).

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Author and article information

Contributors

Li Qi: Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Kun Su: Role: Data curationRole: Formal analysisRole: InvestigationRole: Supervision

Yu Xia: Role: Data curationRole: Formal analysisRole: InvestigationRole: Supervision

Wenge Tang: Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draft

Tao Shen: Role: ConceptualizationRole: MethodologyRole: SoftwareRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Qin Li: Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: Visualization

Eric HY Lau: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 27 November 2019

Publication date Collection: 2019

Volume: 14

Issue: 11

Electronic Location Identifier: e0225569

Affiliations

[1 ] Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China

[2 ] Chinese Hospital Association, Beijing, China

The University of Hong Kong, CHINA

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: wengetang@ 123456163.com

Article

Publisher ID: PONE-D-19-02000

DOI: 10.1371/journal.pone.0225569

PMC ID: 6881008

PubMed ID: 31774839

SO-VID: 7dfe8628-11b4-4e03-85f5-1103c9e35132

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 22 January 2019

Date accepted : 7 November 2019

Page count

Figures: 3, Tables: 5, Pages: 11

Funding

Funded by: Chongqing Health Commission

Award ID: High-level Medical Reserved Personnel Training Project of Chongqing [2019GDRC014]

Award Recipient : Li Qi

Funded by: National Key R&D Program of China

Award ID: 2017YFC0907303

Award Recipient : Wenge Tang

This project was supported by the High-level Medical Reserved Personnel Training Project of Chongqing, Chongqing Health Commission [grant number 2019GDRC014] and the National Key R&D Program of China [grant number 2017YFC0907303]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Data Availability All relevant data are within the manuscript and its Supporting Information files.

Enterovirus 71 vaccine acceptance among parents of children < 5 years old and their knowledge of hand, foot and mouth disease, Chongqing, China, 2017

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Most cited references 22

Clinical features, diagnosis, and management of enterovirus 71.

Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.

An inactivated enterovirus 71 vaccine in healthy children.

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