AsianScientist (Jul. 2, 2011) – Chinese biopharmaceutical company Sinovac Biotech Ltd. announced this week the commencement of a Phase II clinical trial for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).
The safety observation results from the EV71 vaccine Phase I trial completed in May 2011 showed good safety and tolerance profiles for all three age groups (adult, children, and infant groups). The preliminary immunogenicity study results also showed that the vaccine induced good immune responses.
The purpose of the Phase II clinical trial is to determine the dosage level through evaluating the immunogenicity and safety with different level of dosages of Sinovac’s EV71 vaccine candidate, and to provide reference data for the Phase III clinical trial.
The Phase II clinical trial is designed as a single center, randomization, double blinded, and placebo controlled study. 540 healthy volunteers from 3 to 35 months old will be enrolled in three age groups. Dosing with the first shot was started on schedule.
According to Dr. Weidong Yin, Chairman, President & CEO of Sinovac Biotech, the company intends to complete the Phase II clinical trial within the next six months and commence the Phase III clinical trial before spring of 2012. This would allow Sinovac to assess the efficacy of the vaccine candidate within the expanded population during the HFMD outbreak season anticipated in the spring of 2012.
HFMD has become a serious problem in China and the Asia-Pacific region. Although the disease is typically of short duration, there has been an increase in severe HFMD cases associated with the Enterovirus 71, or EV71.
According to the Chinese Ministry of Health’s data available for the period from January 1 to November 30, 2010, the disease caused 876 deaths in China and over 1.73 million HFMD infection cases during the 2010 eleven-month period. HFMD is common among infants and children, as most of the recently reported cases have occurred in children under five years of age.
Other vaccine products being developed by Sinovac include vaccines for Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps, and rubella.
Related Article:
(Jun. 18, 2011) Inviragen Initiates Phase I Study Of Hand, Foot and Mouth Disease Vaccine.
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Source: Sinovac Biotech Ltd.
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