The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis.
机构:
Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Hong Kong, Peoples R China
Queen Mary Hosp, Liver Transplant Ctr, Hong Kong, Hong Kong, Peoples R ChinaUniv Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Fung, James
Seto, Wai-kay
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Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Hong Kong, Peoples R ChinaUniv Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Seto, Wai-kay
Wong, Danny Ka-ho
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Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Hong Kong, Peoples R ChinaUniv Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Wong, Danny Ka-ho
Lai, Ching-lung
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Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Hong Kong, Peoples R ChinaUniv Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Lai, Ching-lung
Yuen, Man-fung
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Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Hong Kong, Peoples R ChinaUniv Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
机构:
Department of Pediatric Gastroen-terology, Sisli Hamidiye Etfal Education and Research HospitalDepartment of Pediatric Gastroen-terology, Sisli Hamidiye Etfal Education and Research Hospital
Merve Usta
Nafiye Urganc?
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机构:Department of Pediatric Gastroen-terology, Sisli Hamidiye Etfal Education and Research Hospital
Nafiye Urganc?
Zeynep Y?ld?z Y?ldlrmak
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机构:Department of Pediatric Gastroen-terology, Sisli Hamidiye Etfal Education and Research Hospital
Zeynep Y?ld?z Y?ldlrmak
Sema Dogan Vural
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Department of Pediatric Oncology, Sisli Hamidiye Etfal Education and Research HospitalDepartment of Pediatric Gastroen-terology, Sisli Hamidiye Etfal Education and Research Hospital
机构:
Hacettepe Univ, Fac Med, Dept Pediat, Ankara, TurkeyHacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, Turkey
Bajin, Inci Yaman
Demir, Hulya
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Hacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, TurkeyHacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, Turkey
Demir, Hulya
Temizel, Inci Nur Saltik
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Hacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, TurkeyHacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, Turkey
Temizel, Inci Nur Saltik
Ozen, Hasan
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Hacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, TurkeyHacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, Turkey
Ozen, Hasan
Yuce, Aysel
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Hacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, TurkeyHacettepe Univ, Fac Med, Div Pediat Gastroenterol Hepatol & Nutr, Ankara, Turkey