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Euroasian J Hepatogastroenterol. 2018 Jul-Dec;8(2):133-139. doi: 10.5005/jp-journals-10018-1279. Epub 2019 Feb 1.
Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac.
Fernández G1, L Sanchez A1, Jerez E1, E Anillo L1, Freyre F2, A Aguiar J2, Leon Y2, Cinza Z2, A Diaz P2, Figueroa N2, Muzio V2, G Nieto G2, Lobaina Y2, Aguilar A2, Penton E2, C Aguilar J2.
Author information
1
Department of Gastroenterology, "Abel Santamaría" Provincial Hospital, Pinar del Rio, Cuba.
2
Department of Vaccine, Biomedical Research, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
Abstract
A novel therapeutic vaccine for chronic hepatitis B (CHB) treatment comprising the recombinant hepatitis B surface (HBsAg) and nucleocapsid (HBcAg) antigens has been developed. Preclinical and clinical trials (CT) evidenced safety and immunogenicity in animal models as well as in phases I, II, and III clinical trials. A phase I CT has conducted in Cuba in 6 CHB patients refractory or incomplete responders to α-IFN. Patients were immunized ten times every two weeks via. nasal spray, with 100 ug HBsAg and 100 ug HBcAg. Clinical efficacy was monitored by assessing the levels of hepatitis B virus deoxyribonucleic acid (HBV DNA), alanine aminotransferase (ALT), HBeAg, and anti-HBeAg seroconversion as well as by qualitative/ quantitative HBsAg serology during this period. After a 5 year follow-up,HBeAg loss was verified in the three HBeAg (+) patients, in two cases with seroconversion to anti-HBeAg. A reduction to undetectable viral load was observed in 5 out of 6 patients, and in two cases HBsAg seroconversion was also detected. ALT increases above the 2X upper limit of normal (ULN) were only detected in HBeAg (+) patients and associated with HBe antigen loss. All patients had stiffness levels below 7.8 KPa by Fibroscan assessment at the end of this period. Although only a few patients were enrolled in this study, it seems that HeberNasvac may maintain some of the therapeutic effects for a prolonged period. How to cite this article: Fernandez G, Sanchez AL, Jerez E, Anillo LE, Freyre F, Aguiar JA, Leon Y, Cinza Z, Diaz PA, Figueroa N, Muzio V, Nieto GG, Lobaina Y, Aguilar A, Penton E, Aguilar JC. Five-year Follow-up of Chronic Hepatitis B Patients Immunized by Nasal Route with the Therapeutic Vaccine HeberNasvac. Euroasian J Hepatogastroenterol, 2018;8(2):133-139.
KEYWORDS:
Chronic hepatitis B; HeberNasvac; Therapeutic vaccine.
PMID:
30828555
PMCID:
PMC6395482
DOI:
10.5005/jp-journals-10018-1279
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发表于 2019-3-5 20:09
