Inviragen to begin hand, foot and mouth disease vaccine

Infectious disease vaccine developer Inviragen is ready to begin a placebo controlled randomized Phase 1 clinical trial of its experimental vaccine INV21 for hand, foot and mouth disease.

INV21 is a highly purified virus particle preparation that has been designed to protect against HFMD, which is caused by enterovirus 71. The study will evaluate INV21’s safety and immune responses in health adult volunteers between the ages of 21 and 45, Pharmaceutical Business Review reports.

Adult volunteers will each receive two immunizations separated by four weeks and will be monitored for any adverse reactions following each administration. The immune responses to the vaccine will be measured one, two and six months after the second immunization.

Joseph Santangelo, the chief operating officer of Inviragen, said that this first clinical study of INV21 is the result of years of research by the company’s scientists and is an important milestone for the company.

"INV21 was developed in Singapore by Inviragen and our preclinical studies have demonstrated that this vaccine induces broad, neutralizing antibodies to multiple EV71 isolates,” Santangelo said, according to Pharmaceutical Business Review.

HFMD is a common viral illness in infants and children that causes fever and blister-like eruptions in the mouth and/or a skin rash. The most common cause of HFMD in the United States is coxsackievirus A16, according to the Centers for Disease Control and Prevention.