Clinical Research Organization
crobangladesh@gmail.com
+8801819251514
Phase III clinical trial of NASVAC
NASVAC is a novel therapeutic vaccine containing both hepatitis B surface antigen and hepatitis B core antigen. Phase III clinical trial of NASVAC was done by CRO Ltd. in treatment naive patients with chronic hepatitis B. It was an open phase III, randomized and treatment controlled clinical trial, allocated into two groups to receive NASVAC or Pegylated Interferon. This is the first time any therapeutic vaccine entered a phase III clinical trial anywhere in the world, not only for chronic hepatitis B, but for any chronic infection in humans.
The sponsor of the study was Center for Genetic Engineering and Biotechnology, Cuba. The clinical trial was monitored by Director General of Drug Administration, Bangladesh and Centro para el Control Estatal de Medicamentos (CECMED), Cuba. NASVAC is commercialized in Cuba and several other countries and the recipe of NASVAC has been approved by the Drug Control Committee of Bangladesh Government.
In Cuba, NASVAC is commercialized as HeberNasvac, which is the first immune modulatory drug for chronic hepatitis B with finite duration of administration. It is also the first therapeutic vaccine, which is administered through the nasal route in humans. Currently CRO Ltd. has followed up patients of Phase III clinical trial of NASVAC at two, three, five and ten years.