AsianScientist (Jun. 18, 2011) – Inviragen announced this week the initiation of the first clinical trial of its proprietary Hand, Foot and Mouth Disease (HFMD) investigational vaccine in Singapore.
INV21 is a highly purified virus particle preparation designed to protect against HFMD caused by enterovirus 71 (EV71). The study will be conducted in Singapore at the Investigational Medicine Unit at the National University Health System under Inviragen’s memorandum of understanding with the Duke-NUS Graduate Medical School.
This Phase 1 clinical trial of INV21 will assess the safety of the vaccine as well as immune responses in healthy adult volunteers.
“INV21 was developed in Singapore by Inviragen and our preclinical studies have demonstrated that this vaccine induces broad, neutralizing antibodies to multiple EV71 isolates,” said Dr. Joseph Santangelo, Inviragen’s chief operating officer.
The trial is a placebo controlled randomized clinical study and will enroll healthy adults, aged 21 to 45 years. Each individual will receive two immunizations separated by four weeks and will be monitored for any adverse reactions after each administration. Immune responses to INV21 will be measured one, two and six months after the second immunization.
HFMD is endemic in the Asia Pacific where its incidence has been increasing steadily over the past two decades. Although the disease is typically of short duration, there has been an increase in severe HFMD cases, including central nervous system involvement, associated with EV71. HFMD epidemics have been reported in most Asian countries, particularly Singapore, Taiwan, Malaysia, Vietnam, Korea, Hong Kong and China.
Recent reports from the Chinese Ministry of Health revealed more than 1.7 million HFMD infections resulting in 876 deaths from 1 January to 30 November 2010; there were 1.1 million infections with 353 deaths reported for the previous year. No vaccines currently exist for HFMD.
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Source: Inviragen.
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