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International Session（Symposium）2(JSH・JSGE・JSGCS)
Thu. October 31st   14:30 - 17:00   Room 11: Portopia Hotel South Wing Topaz
IS-S2-5_H
 Intranasal vaccine containing HBsAg/HBcAg for treating and preventing hepatitis B virus infection
Osamu Yoshida1, Yusuke Imai1, Yoichi Hiasa1
1Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Objective: HBV infection is a globally serious problem because of its high mortality. Prophylaxis and adequate treatment are the essential strategy for HBV elimination. HB vaccination is effective for HBV prophylaxis, however 5-10% individuals cannot produce anti-HBs after HB vaccination. Interferons and nucleos(t)ide analogues are the two major drugs for treating HBV, however these anti-HBV drugs cannot achieve the ideal treatment goal, HBsAg loss. We have developed a nasal administrative, HBs/HBc antigen containing vaccine, named CVP-NASVAC, for HBV treatment and prophylaxis.
Methods: We conducted clinical trials for HBV treatment and prophylaxis. N=72 HBV infected patients and n=68 healthy individuals were enrolled. HBV patients received CVP-NASVAC total 10 doses biweekly, healthy individuals received CVP-NASVAC 3 doses biweekly.
Results: 57 HBV patients (33 male and 24 female, median age: 52, under NAs treatment: n=24 (42.1%), re-treatment: n=38 (66.6%)) reached to 5 years follow-up. Mean HBsAg reduction was -54.9% (-0.572 LogIU/mL). 14.0% (n=8/57) HBV patients lost HBsAg. 50.9% (n=29/57) maintained anti-HBs at 5 years follow-up. N=25/28 (89.3%) HB vaccine responders acquired more than 500 mIU/mL titer of anti-HBs after CVP-NASVAC treatment. N=36/40 (90.0%) HB vaccine non-responders developed anti-HBs after CVP-NASVAC vaccination.
Conclusion: CVP-NASVAC reduced HBsAg in HBV carriers and induced anti-HBs in HB vaccine non-responders. CVP-NASVAC is useful for HBV prophylaxis and treatment, and might contribute to HBV elimination.
Index Term 1: HBV prophylaxis
Index Term 2: HBV therapeutic vaccine
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