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.
Highlights
With an estimated of more than 240 million people infected worldwide, chronic hepatitis B (CHB) remains a major public health problem
Several vaccine candidates have been clinically tested in CHB patients, their efficacies have been limited or inconclusive.[3]
A novel vaccine formulation called HeberNasvac has been tested in preclinical and clinical studies. This product was originally developed as a nasal vaccine for CHB immunotherapy that comprises the hepatitis B virus (HBV) surface and core recombinant virus-like particles (VLP).[4,5]
Summary
With an estimated of more than 240 million people infected worldwide, CHB remains a major public health problem. A novel vaccine formulation called HeberNasvac has been tested in preclinical and clinical studies This product was originally developed as a nasal vaccine for CHB immunotherapy that comprises the hepatitis B virus (HBV) surface and core recombinant virus-like particles (VLP).[4,5] Preclinical studies including immuno-toxicological evaluations using HBsAg-transgenic mice have been completed.[6,7] HeberNasvac was very immunogenic in mice after intranasal (IN) or parenteral administrations inducing high antibody titers, potent proliferative responses and the secretion of gamma interferon by spleen cells.[4,5,6,7] The formulation demonstrated its safety and preliminary immunogenicity in a phase I CT in healthy volunteers.[8] Phase I, II and III CT9,10 conducted in Bangladesh, a country with intermediate to high preva-
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