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

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Abstract

Purpose

The safety and clinical efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (HBsAg/HBcAg) were evaluated in patients with chronic hepatitis B (CHB).

Methods

Eighteen patients with CHB were administered a vaccine containing 100 μg of HBsAg and 100 μg of HBcAg. The vaccine was administered ten times at 2-weekly intervals, the first five times via the nasal route only and the subsequent five times via both nasal and subcutaneous routes. The safety and efficacy of this therapeutic approach were assessed by periodic assessment of the patients’ general condition, viral kinetics, and biochemical parameters during treatment and 24 and 48 weeks after therapy. The production of cytokines by peripheral blood mononuclear cells (PBMC) and antigen-pulsed dendritic cells (DC) was evaluated to assess the immunomodulatory effects of the HBsAg/HBcAg vaccine in CHB patients.

Results

The HBsAg/HBcAg vaccine was safe in all patients. No flare of HBV DNA or alanine aminotransferase (ALT) was recorded in any patient. Sustained HBV DNA negativity and persistently normalized ALT were detected in 9 (50 %) and 18 (100 %) patients with CHB, respectively. PBMC and HBsAg/HBcAg-pulsed DCs from HBsAg/HBcAg-vaccinated CHB patients produced significantly higher levels of various cytokines [interleukin 1β (IL-1β), IL-6, IL-8, IL-12, and tumor necrosis factor α (TNF-α)] than those from control unvaccinated CHB patients (p < 0.05) after stimulation with HBsAg/HBcAg in vitro.

Conclusion

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

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Compliance with Ethical Requirements

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, and Farabi Hospital, Dhaka, Bangladesh, and with the Declaration of Helsinki 1975, as revised in 2008. Informed consent was obtained from all patients for their inclusion in the study.

Conflict of interest

Mamun Al-Mahtab, Sheikh Mohammad Fazle Akbar, Julio Cesar Aguilar, MD, Helal Uddin, MD, Sakirul Islam Khan, and Salimur Rahman declare that they have no conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Mamun Al-Mahtab & Salimur Rahman

  2. Department of Medical Sciences, Toshiba General Hospital, Higashi Oi 6-3-22, Tokyo, 140-8522, Japan

    Sheikh Mohammad Fazle Akbar

  3. Center for Genetic Engineering and Biotechnology, Havana, Cuba

    Julio Cesar Aguilar

  4. Clinical Research Organization, Dhaka, Bangladesh

    Md. Helal Uddin

  5. Bangladesh Agricultural University, Mymensign, Bangladesh

    Md. Sakirul Islam Khan

Authors
  1. Mamun Al-Mahtab
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  2. Sheikh Mohammad Fazle Akbar
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  3. Julio Cesar Aguilar
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  4. Md. Helal Uddin
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  5. Md. Sakirul Islam Khan
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  6. Salimur Rahman
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Corresponding author

Correspondence to Sheikh Mohammad Fazle Akbar.

Additional information

Mamun Al-Mahtab and Sheikh Mohammad Fazle Akbar contributed equally to this study.

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Al-Mahtab, M., Akbar, S.M.F., Aguilar, J.C. et al. Therapeutic potential of a combined hepatitis B virus surface and core antigen vaccine in patients with chronic hepatitis B. Hepatol Int 7, 981–989 (2013). https://doi.org/10.1007/s12072-013-9486-4

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  • DOI: https://doi.org/10.1007/s12072-013-9486-4

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