Therapeutic potential of a combined hepatitis B virus surface and core antigen vaccine in patients with chronic hepatitis B

Al‐Mahtab, Mamun; Akbar, Sheikh Mohammad Fazle; Aguilar, Julio César; Uddin, Mohammad Zashim; Khan, Md. Sakirul Islam; Rahman, Salimur

doi:10.1007/s12072-013-9486-4

Cited by 56 publications

(65 citation statements)

References 30 publications

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“…Recombinant HBcAg, in combination with HBsAg, has been evaluated in chronic hepatitis B patients, resulting in normalized ALT levels in all of them and no detectable HBV DNA in half of them [36,42] . These results support further evaluations of the combined HBV antigens we have reported in this study as therapeutic reagents.…”

Section: Discussionmentioning

confidence: 99%

Humoral Immune Response in Mice Elicited by Combined Yeast-Derived Hepatitis B Virus Core, Surface, and Mosaic Surface Antigens

Granovski¹,

Yokosawa²,

Rodrigues-Granovski³

et al. 2017

Intervirology

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Background: Although successful, the second-generation hepatitis B vaccine programs around the world have a small group of immunized individuals that does not respond efficiently to the vaccination. Other issues of these vaccines are individuals that are low or nonresponders and/or have incomplete protection against heterologous hepatitis B virus (HBV) genotypes/subtypes and against HBV escape mutants. In addition, there are approximately 240 million people chronically infected with HBV worldwide and 620,000 deaths per year caused by the infection. Methods: In this study we developed three Hansenula polymorpha plasmids containing the following sequences: (a) HBsAg subtype ayw, (b) HBcAg sequence subtype adw2, and (c) chimeric HBsAg (adw4/ ayw) - preS1 (adw2) - 3 repetitions of preS2 (genotypes A, B, and C). The sequences were successfully expressed and the antigens purified. Using Balb/c mice the antigens were tested in different dosage combinations. Results: Three antigens were obtained at a high purity level and with high reproducibility. We also assessed their immunogenic properties, showing that the antigens, individually or in combination, generated anti-HBs, anti-preS1, anti-preS2, and anti-HBc antibodies efficiently in mice. Conclusions: The formulation tests showed that a combination of 0.02 μg of HBs, 0.2 μg of preS1-preS2-HBs, and 0.02 μg of HBc was effective in eliciting specific antibodies in mice.

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Section: Discussionmentioning

confidence: 99%

Humoral Immune Response in Mice Elicited by Combined Yeast-Derived Hepatitis B Virus Core, Surface, and Mosaic Surface Antigens

Granovski¹,

Yokosawa²,

Rodrigues-Granovski³

et al. 2017

Intervirology

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“…These results indicated that NASVAC was safe and efficiently overcome the immune tolerance in CHB patients. 61 In the following phase IIb/III clinical trial, 160 CHB patients were enrolled, 151 of them completed the trial. 75 patients received 100 mg HBsAg and 100 mg HBcAg 5 times.…”

Section: Hbsag Combines Antiviral Drugsmentioning

confidence: 99%

Research progress of therapeutic vaccines for treating chronic hepatitis B

Li¹,

Bao²,

Ge³

et al. 2017

Human Vaccines & Immunotherapeutics

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Hepatitis B virus (HBV) is a member of Hepadnavirus family, which leads to chronic infection in around 5% of patients with a high risk of developing liver cirrhosis, liver failure, and hepatocellular carcinoma. Despite the availability of prophylactic vaccines against hepatitis B for over 3 decades, there are still more than 2 billion people have been infected and 240 million of them were chronic. Antiviral therapies currently used in the treatment of CHB (chronic hepatitis B) infection include peg-interferon, standard a-interferon and nucleos/tide analogs (NAs), but none of them can provide sustained control of viral replication. As an alternative strategy, therapeutic vaccines for CHB patients have been widely studied and showed some promising efficacies in dozens of preclinical and clinical trials. In this article, we review current research progress in several types of therapeutic vaccines for CHB treatment, including proteinbased vaccines, DNA-based vaccines, live vector-based vaccines, peptide-based vaccines and cell-based therapies. These researches may provide some clues for developing new treatments in CHB infection.

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“…The phase I/II trial in Bangladesh enrolled 18 treatment-naïve patients [9]. The vaccine was administered ten times at 2-weekly intervals, the first five doses via nasal route only and the subsequent five doses via both nasal and subcutaneous routes.…”

Section: Clinical Phase Of Developmentmentioning

confidence: 99%

“…The vaccine is based on a combination of the HBsAg and the HBV nucleocapsid (HBcAg) antigens and is simultaneously administered by the intranasal and subcutaneous routes [6,7]. ABX203 has been studied in phase I, phase II and phase III clinical trials with promising results [8][9][10]. In the present work we reviewed the results of the main preclinical and clinical trials of this product.…”

mentioning

confidence: 99%

ABX203, a novel therapeutic vaccine for chronic hepatitis B patients

2016

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Despite the existence of effective prophylactic vaccines, chronic hepatitis B remains a major public health problem, with more than 350 million people infected worldwide. Chronic infection increases the risk of serious liver diseases such as cirrhosis and hepatocellular carcinoma. Available therapies for chronic hepatitis B have limited efficacy and require long-term continuous treatments; that is why the development of therapeutic vaccines has been investigated as promising approach. In this sense, a novel vaccine formulation called ABX203 (HeberNasvac), based on the combination of the hepatitis B virus nucleocapsid and surface antigens, was developed. ABX203 has been studied in phase I, phase II and phase III clinical trial in treatment-naïve chronically infected patients in Bangladesh and in healthy volunteers in Cuba with promising results. In the present work we reviewed the main preclinical and clinical results of ABX203 development. Altogether, the data demonstrates safety and immunogenicity of ABX203 vaccine and support its use as a novel and competitive treatment alternative for chronic hepatitis B. The vaccine has been granted marketing authorization in Cuba.

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Therapeutic potential of a combined hepatitis B virus surface and core antigen vaccine in patients with chronic hepatitis B

Abstract: HBsAg/HBcAg vaccine seems a safe and efficient therapeutic approach for patients with CHB.

Cited by 56 publications

References 30 publications

Humoral Immune Response in Mice Elicited by Combined Yeast-Derived Hepatitis B Virus Core, Surface, and Mosaic Surface Antigens

Humoral Immune Response in Mice Elicited by Combined Yeast-Derived Hepatitis B Virus Core, Surface, and Mosaic Surface Antigens

Research progress of therapeutic vaccines for treating chronic hepatitis B

ABX203, a novel therapeutic vaccine for chronic hepatitis B patients

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