Hand-Foot-Mouth Disease – Enterovirus 71 Vaccine Study in Children

MedicalResearch.com eInterview with: Fengcai Zhu Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, Jiangsu provincial center for disease prevention and control

Fengcai Zhu

Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control,
Jiangsu provincial center for disease prevention and control

MedicalResearch.com Editor’s Note:
HFMD = Hand Foot and Mouth Disease
Hand Foot and Mouth Disease

MedicalResearch.com: What are the main findings of the study?

Answer: From this trial, the inactivated alum-adjuvant EV71 vaccine showed a good protection for both the EV71-associated HFMD and EV71-associated disease. The vaccine gave 90% protection against clinical EV71-associated HFMD and 80.4% against EV71-associated disease (including neurological complications) for at least 12 months. The safety profile and immunogenicity of this vaccine is proved to be clinical acceptable. We also proposed a titre (1:32) of neutralization antibody as surrogate of protection against EV71-associated disease.

MedicalResearch.com: Were any of the findings unexpected?

Answer: One of the unexpected results is that EV71 is not a dominated pathogen during the 12-month surveillance. When we chose the study centres, epidemic data from Nationwide Notifiable Infectious Diseases Reporting Information System (NIDRIS) in China in the last 3 years were referenced. But the existing NIDRIS was a passive surveillance system and neither sensitive nor specific enough. These reasons made a precise forecasting of EV71 epidemic intensity in the coming year is not practicable. Therefore, the multicenter is very essential for the successful of this efficacy trial.

Another unexpected thing is that in all the confirmed EV71-associated disease, the EV71 disease with non-specific manifestation such as fever, cough, or diarrhea, had been reported in epidemiologic studies, but claimed a small proportion of all EV71 cases, normally around 4% to 8%. In our study, the upper respiratory tract infection symptoms occurred in more than 25% (14/52) of cases.

MedicalResearch.com: What should clinicians and patients take away from your report?

Answer: Because there is no specific treatment for the EV71-associated HFMDs, so prevention is more important. I hope the novel EV71 vaccine could protect more young children and infants from the potential death EV71 disease. Clinicians should pay their attention on the prevention of the hospital infection in the season of HFMD. If a HFMD case is confirmed, clinicians should tell the parents that their children should be quarantined, and avoid to go to public places before recovery.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Answer: A lot of research needs to be done next, including the combined use of EV71 vaccine and other inactivated vaccines, the economic benefit evaluation of EV71 vaccine and post-marketing phase IV studies on rare adverse events monitoring, and so on.

Citation:

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

Feng-Cai Zhu MSc,Fan-Yue Meng MSc,Jing-Xin Li MSc,Xiu-Ling Li MSc,Qun-Ying Mao PhD,Hong Tao BS,Yun-Tao Zhang PhD,Xin Yao PhD,Kai Chu MSc,Qing-Hua Chen MSc,Yue-Mei Hu BS,Xing Wu MSc,Pei Liu PhD,Lin-Yang Zhu BS,Fan Gao MSc,Hui Jin PhD,Yi-Juan Chen MSc,Yu-Ying Dong MSc,Yong-Chun Liang BS,Nian-Min Shi MSc,Heng-Ming Ge BS,Lin Liu BS,Sheng-Gen Chen BS,Xing Ai MSc,Zhen-Yu Zhang BS,Yu-Guo Ji BS,Feng-Ji Luo MSc,Xiao-Qin Chen BS,Ya Zhang BS,Li-Wen Zhu BS,Zheng-Lun Liang PhD,Xin-Liang Shen MSc
The Lancet – 29 May 2013
DOI: 10.1016/S0140-6736(13)61049-1

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Press Release:

Sinovac EV71 Vaccine Phase III Top-Line Results Presented at 13th Annual World Vaccine Congress & Expo

— Efficacy and Safety Data for EV71 Vaccine Discussed in Presentation by Deputy Director of Jiangsu Provincial CDC

BEIJING, April 18, 2013  /PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of vaccines in China, announced today that Fengcai Zhu, Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, presented data regarding Sinovac’s proprietary enterovirus 71 (“EV71”) vaccine against hand, foot and mouth disease (“HFMD”) at the 13th Annual World Vaccine Congress & Expo, taking place from April 16-18, 2013, in Washington D.C. Dr. Fengcai Zhu acted as a co-principal investigator in Sinovac’s phase III trial for its EV71 vaccine.

Dr. Fengcai Zhu delivered a presentation entitled “The clinical evaluation of new vaccines in China,” at 12:25 pm EDT on April 17, 2013. In his presentation, Dr. Fengcai Zhu discussed the efficacy and safety of the Company’s EV71 vaccine. Data from the Phase III trial indicated that our EV71 vaccine had 95% efficacy against EV71-associated HFMD /herpangina, and 100% efficacy against EV71-associated hospitalization.  Herpangina is a painful mouth infection that can be caused by EV71.

There were no significant differences between the vaccine group and the placebo group for the adverse reaction symptoms and incident rate in the phase III trial.

The double-blinded, randomized, placebo controlled phase III clinical trial was conducted at three sites across China’s Jiangsu province. Approximately 10,000 healthy infants completed the two-dose vaccination schedule (at day 0 and day 28) in the first quarter of 2012, prior to the HFMD epidemic season in China. Trial participants were then followed in an active monitoring period.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza and mumps, as well as animal rabies vaccine.  In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program.  The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program.  Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot, and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, varicella and rubella.  Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac was also granted a license to commercialize seasonal flu vaccine in Mexico.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Helen Yang
Sinovac Biotech Ltd.
Tel:  +86-10-8279-9871
Fax:  +86-10-6296-6910
Email: ir@sinovac.com

Interview Updated 5/30/2013

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