A PHASE III CLINICAL TRIAL WITH A NASAL VACCINE CONTAINING BOTH HBSAG AND HBCAG IN PATIENTS WITH CHRONIC HEPATITIS B
M.A. Mahtab1*, F. Akbar2, H. Uddin3, S. Rahman1, J.C.A. Rubido4, G.E.G. Nieto4, M. Onji5, S. Mishiro2
1Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, 2Medical Sciences, Toshiba General Hospital, Tokyo, Japan, 3Clinical Research Organization, Dhaka, Bangladesh, 4Center for Genetic Engineering and Biotechnology, Havana, Cuba, 5Gastroenterology & Metabology, Ehime University School of Medicine, Matsuyama, Japan. ****@****
Background and aims: The therapeutic efficacy of hepatitis B surface antigen (HBsAg)-based vaccine was not satisfactory even when this vaccine was used with antiviral drugs in patients with chronic hepatitis B. The phase III clinical trial described here was accomplished to develop a better therapeutic approach of immune therapy in CHB patients with modifications in nature of therapeutic vaccines and route of administration.
Methods: A phase III clinical trial was done with 151 patients with CHB with similar levels of HBV DNA and alanine aminotransferase (ALT). They were randomly assigned to receive either a therapeutic vaccine or pegylated interferon (Peg-IFN). Seventy-five CHB patients received a therapeutic vaccine containing 100 microgram of both HBsAg and hepatitis B core antigen (HBcAg) (HBsAg/HBcAg) (Center for Genetic Engineering and Biotechnology, Havana, Cuba), once in every two weeks, for 5 times through nasal route administered by a newly developed nasal vaccine device. Seventy-six patients with CHB received PEG-IFN (180 µgm sub-cutaneously once weekly for 48 weeks), once a week for 48 weeks.
Results: Notable adverse effects or acute flare of hepatitis was not detected in any patient of either group. All patients with CHB were expressing HBV DNA in the sera before study commencement; however 37 of 75 patients receiving HBsAg/HBcAg vaccine became negative for HBV DNA after receiving 5 vaccinations through nasal route. The levels ALT showed an early elevation in 90% patients receiving HBsAg/HBcAg therapeutic vaccine and then declined to below upper limit of normal value (< 42U/L) in 46 of 75 patients. Out of 76 patients, 48 patients with CHB receiving Peg IFN became negative for HBV DNA and 36 express normal levels of ALT after the end of IFN therapy (48 weeks after therapy commencement).
Conclusions: A therapeutic vaccine therapy containing HBsAg/HBcAg represents a promising therapeutic approach for CHB patients Therapeutic efficacy of 5 vaccinations with therapeutic vaccine containing HBsAg/HBcAg-based vaccine by nasal route is almost comparable with 48-weeks treatment with Peg-IFN. Follow up study of this phase III clinical trial would yield important information about the role of nasally-administered HBsAg/HBcAg-based therapeutic vaccine in CHB.
Dr. Mamun Mahtab, Bangabandhu Sheikh Mujib Medical University , Dhaka , Bangladesh
Assigned in sessions:
26.04.2013, 09:00-18:00, Poster Session, P02-07c, Category 07c: Viral Hepatitis B & D: Clinical (therapy, new compounds, resistance), Poster Area
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