SINGAPORE - The randomized Phase 1 trial of INV21, a highly purified virus particle vaccine against Hand, Foot and Mouth Disease (HFMD), has produced immune responses in 100 per cent of individuals tested, its developer Inviragen said.
The vaccine is the result of a collaboration between Singapore academic clinicians and local industry partners in addressing emerging infectious diseases threats.
In the clinical study, healthy adults received two immunizations each of either a high- or low-dose formulation of INV21, and monitored for safety and for immune response after each administration.
Antibodies that neutralize the HFMD virus were measured in individuals who received both doses of the vaccine.
The finding that 100 per cent of the subjects tested had significant increase in immune response against the infection signifies that the vaccone my offer protection against the infection.
The vaccine was also found to be safe and well tolerated.
HFMD is a significant public health problem in East Asia, including Singapore, affecting approximately two million children every year.
In recent weeks, the number of HFMD cases in Singapore has risen past the epidemic threshold, as defined by the Ministry of Health.
"We were able to initiate this study rapidly and complete it in only six months through a productive relationship with the Singapore National University Health System (NUHS) and our collaboration with Duke-NUS Graduate Medical School," commented Dr. Joseph Santangelo, Inviragen's chief operating officer.
Dr Santangelo added that they will be exploring the vaccine's safety and immunogenicity in children in future clinical trials later this year.