2015, Number 3
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Biotecnol Apl 2015; 32 (3)
Demonstration of safety, immunogenicity and evidences of efficacy of the therapeutic vaccine candidate HeberNasvac and characterization of chronic hepatitis B patient populations
Lobaina Y, Aguiar J, Pentón E, Guillen G, Al Mahtab M, Uddin H, Raihan R, Akbar F, Pujol F, Loureiro CL, Aguilar JC
Language: English
References: 12
Page: 3511-3513
PDF size: 194.91 Kb.
ABSTRACT
Chronic hepatitis B remains as a major public health problem, with more than 350 million people infected worldwide. Available therapies have limited efficacy and require long-term continuous treatments, further encouraging the development of therapeutic vaccines as a promising approach. In this sense, a new vaccine formulation called HeberNasvac was developed, which is based on the combined administration of the HBV nucleocapsid (HBcAg) and surface (HBsAg) antigens by the intranasal and the subcutaneous routes. In this work, we present some of the achievements of HeberNasvac clinical development studies, particularly summarized data from Phase I and II clinical trials. Altogether, our results demonstrated the good safety and immunogenicity profiles of the HeberNasvac vaccine, providing it as a novel and competitive treatment against chronic hepatitis B. In parallel, the chronic hepatitis B infected populations in Cuba and Bangladesh were characterized, attending to virological, serological, biochemical and histological parameters. This research granted the 2014 Award of the Cuban National Academy of Sciences.
REFERENCES
El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012;142(6):1264-73.
Lok ASF. The maze of treatments for hepatitis B. N Engl J Med. 2005;352(26) :2743-6.
Michel ML, Deng Q, Mancini-Bourgine M. Therapeutic vaccines and immune-based therapies for the treatment of chronic hepatitis B: Perspectives and challenges. J Hepatol. 2011;54:1286-96.
Aguilar JC, Lobaina Y, Muzio V, Garcia D, Penton E, Iglesias E, et al. Development of a nasal vaccine for chronic hepatitis B infection that uses the ability of hepatitis B core antigen to stimulate a strong Th1 response against hepatitis B surface antigen. Immunol Cell Biol. 2004;82:539-46.
Lobaina Y, Trujillo H, Garcia D, Gambe A, Chacón Y, Blanco A, et al. The effect of the parenteral route of administration on the immune response to simultaneous nasal – parenteral immunizations using a new HBV therapeutic vaccine candidate. Viral Immunol. 2010;23(5):521-9.
Aguilar-Betancourt A, Gonzalez CA, Cinza Z, Cabrera JM, Veliz G, Moreno SR, et al. Phase I clinical trial in healthy adults of a nasal vaccine candidate containing recombinant hepatitis B surface and core antigens. Int J Infect Dis. 2007;11:394-401.
Al-Mahtab M, Akbar SM, Aguilar JC, Uddin H, Khan SI, Rahman S. Therapeutic potential of a combined hepatitis B virus surface and core antigen vaccine in patients with chronic hepatitis B. Hepatol Int. 2013;7:981-9.
Downs RW, Bell NH, Ettinger MP, Walsh BW, Favus MJ, Mako B, et al. Comparison of Alendronate and intranasal Calcitonin for treatment of osteoporosis in postmenopausal women. J Clin Endocrinol Metab. 2000;85:1783-8.
Nichol KL, Mendelman PM, Mallon KP, Jackson LA, Gorse GJ, Belshe RB, et al. Effectiveness of live, attenuated intranasal Influenza virus vaccine in healthy, working adults a randomized controlled trial. JAMA. 1999;282(2):137-44.
Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine in children. N Engl J Med. 1998; 338:1405-12.
Loureiro CL, Aguilar JC, Aguiar J, Muzio V, Pentón E, Garcia D, et al. HBV Genotypic variability in Cuba. PLoS ONE. 2015;10(3):e0118959.
Raihan R, Tabassum S, Nessa A, Jahan M, Al Mahtab M, Mohammad C, et al. High HBcAg expression in hepatocytes of chronic hepatitis B patients in Bangladesh. Eursasian J Hepatogastroenterol. 2012;2(2):63-9.