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An inactivated enterovirus 71 vaccine in healthy children
Rongcheng Li1, Longding Liu, Zhaojun Mo
1From Guangxi Province Center for Disease Control and Prevention, Nanning (R.L., Z.M., Y. Li, T.H., Y.N.), Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming (L.L., Y.Z., Jingjing Wang, L.J., C.D., Y.C., Z.X., L.W., Y. Liao, Y. Liang, J.L., H.Z., R.N., L.G., J.P., E.Y., L.S., P.C., H.S., Q.L.), Key Laboratory Medical Molecular Virology, Ministries of Education and Health, and the Institutes of Biomedical Science, Shanghai Medical College, Fudan University, Shanghai (X.W.), Department of Health Statistics, Fourth Military Medical University, Xi'an (J.X., Z.J.), and National Institutes for Food and Drug Control, Beijing (Z.L., Q.M., Junzhi Wang) - all in China.
Insights
An inactivated Enterovirus 71 (EV71) vaccine showed high efficacy in preventing hand, foot, and mouth disease in children. The vaccine demonstrated a 97.4% efficacy rate, indicating a significant protective immune response.
Area of Science:
- Virology
- Immunology
- Pediatrics
Background:
- Enterovirus 71 (EV71) is a significant pathogen causing severe hand, foot, and mouth disease (HFMD) in children.
- EV71 infections can lead to fatal neurological complications, highlighting the urgent need for effective preventative measures.
Purpose of the Study:
- To evaluate the efficacy and immunogenicity of an inactivated EV71 vaccine in a pediatric population.
- To assess the safety profile of the EV71 vaccine through a rigorous clinical trial.
Main Methods:
- A randomized, double-blind, placebo-controlled phase 3 trial was conducted in China involving 12,000 healthy children aged 6–71 months.
- Participants received two intramuscular doses of the inactivated EV71 vaccine or placebo, with a 4-week interval, and were monitored for up to 11 months.
- Primary endpoint was protection against EV71-associated HFMD; secondary assessments included antibody responses and adverse events.
Main Results:
- The inactivated EV71 vaccine achieved a 100% seroconversion rate 4 weeks post-vaccination.
- Vaccine efficacy was high, reaching 97.4% (95% CI, 92.9 to 99.0) for intention-to-treat analysis.
- Fever was a more common adverse event in the vaccine group (41.6%) compared to placebo (35.2%) in the week following vaccination.
Conclusions:
- The inactivated EV71 vaccine is effective in inducing specific immune responses and providing robust protection against EV71-associated HFMD.
- The study supports the use of this vaccine for the prevention of EV71 infections in children.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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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