Immunogenicity and safety of a novel yeast Hansenula polymorpha-derived recombinant Hepatitis B candidate vaccine in healthy adolescents and adults aged 10-45 years

Vaccine

Volumn 28, Issue 20, 2010, Pages 3595-3601

  Tregnaghi, Miguel W ^a   Voelker, Ricardo ^b   Santos Lima, Eduardo ^c   Zambrano, Betzana ^d  

^a Centro de Desarrollo de Proyectos Avanzados Cordoba   (Argentina)

^b Sistema de Emergencia Médico Móvil Dirección de Medicina Preventiva   (Uruguay)

^c SANOFI PASTEUR   (France)

^d NONE   (Uruguay)

Author keywords

Aluminum hydroxide adjuvant; Hansenula polymorpha; Hepatitis B vaccination; Hepatitis B virus; Immunogenicity; Recombinant hepatits B surface antigen; Vaccination

Indexed keywords

HEPATITIS B SURFACE ANTIBODY; RECOMBINANT HEPATITIS B VACCINE;

ADOLESCENT; ADULT; ANTIBODY TITER; ARGENTINA; ARTICLE; ASTHENIA; BLOOD SAMPLING; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEPATITIS B; HUMAN; IMMUNOGENICITY; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; PHASE 3 CLINICAL TRIAL; PICHIA ANGUSTA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; URUGUAY; VOMITING;

ADOLESCENT; ADULT; ARGENTINA; CHILD; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMANS; MALE; MIDDLE AGED; PICHIA; SINGLE-BLIND METHOD; URUGUAY; YOUNG ADULT;

EID: 77950594831     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.02.049     Document Type: Article

References (30)

1. Caldwell S., and Park S.H. The epidemiology of hepatocellular cancer: from the perspectives of public health problem to tumor biology. J Gastroenterol 44 Suppl. 19 (2009) 96-101
2. World Health Organisation. Expanded programme on immunization. Global advisory group - part I. Weekly Epidemiol Rec 67 (1992) 11-15
3. WHO Int (serial online). Hepatitis B. Immunization, vaccines and biologicals; 2008. http://www.who.int/immunization/topics/hepatitis_b/en/index.html [accessed 11.03.09].
4. Liaw Y.F., Chu C.M., Huang M.J., Sheen I.S., Yang C.Y., and Lin D.Y. Determinants for hepatitis B e antigen clearance in chronic type B hepatitis. Liver 4 5 (1984) 301-306
5. Grosheide P., and van Damme P. In: Viral Hepatitis Prevention Board Secretariat, and B.1 (Ed). Prevention and control of Hepatitis B in the community. Communicable Diseases Series vol. 1 (2009) 17
6. Silveira T.R., da Fonesca J.C., Rivera L., Fay O.H., Tapia R., Santos J.I., et al. Hepatitis B seroprevalence in Latin America. Rev Panam.Salud Publica 6 6 (1999) 378-383
7. Tanaka J., and Hepatitis B. epidemiology in Latin America. Vaccine 18 Suppl. 1 (2000) S17-S19
8. Hepatitis B vaccines. In: Mast E., Ward J., Plotkin S., Orenstein W., Offit P.A., and Plotkin S. (Eds). Vaccines. 5th ed. (2008) 205-241
9. Raz R., Dagan R., Gallil A., Brill G., Kassis I., and Koren R. Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children. Vaccine 14 3 (1996) 207-211
10. Shouval D., Ilan Y., Adler R., Deepen R., Panet A., Even-Chen Z., et al. Improved immunogenicity in mice of a mammalian cell-derived recombinant hepatitis B vaccine containing pre-S1 and pre-S2 antigens as compared with conventional yeast-derived vaccines. Vaccine 12 15 (1994) 1453-1459
11. Yerushalmi B., Raz R., Blondheim O., Shumov E., Koren R., and Dagan R. Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in neonates. Pediatr Infect Dis J 16 6 (1997) 587-592
12. Huang Y., Bi J., Zhang Y., Zhou W., Li Y., Zhao L., et al. A highly efficient integrated chromatographic procedure for the purification of recombinant hepatitis B surface antigen from Hansenula polymorpha. Protein Expr Purif 56 2 (2007) 301-310
13. Diminsky D., Schirmbeck R., Reimann J., and Barenholz Y. Comparison between hepatitis B surface antigen (HBsAg) particles derived from mammalian cells (CHO) and yeast cells (Hansenula polymorpha): composition, structure and immunogenicity. Vaccine 15 6-7 (1997) 637-647
14. Heijtink R.A., Bergen P., Melber K., Janowicz Z.A., and Osterhaus A.D. Hepatitis B surface antigen (HBsAg) derived from yeast cells (Hansenula polymorpha) used to establish an influence of antigenic subtype (adw2, adr, ayw3) in measuring the immune response after vaccination. Vaccine 20 17-18 (2002) 2191-2196
15. Dupont J., Altclas J., Lepetic A., Lombardo M., Vazquez V., Salgueira C., et al. A controlled clinical trial comparing the safety and immunogenicity of a new adjuvanted hepatitis B vaccine with a standard hepatitis B vaccine. Vaccine 24 49-50 (2006) 7167-7174
16. Rebedea I., Diaconescu I.G., Bach D., Bartelsen O., and Arndtz N. Comparison of thiomersal-free and thiomersal-containing formulations of a recombinant hepatitis B vaccine (Hepavax-Gene) in healthy adults. Vaccine 24 25 (2006) 5320-5326
17. Velu V., Nandakumar S., Shanmugam S., Shankar E.M., Thangavel S., Kulkarni P.S., et al. Comparative efficacy of two dosages of recombinant hepatitis B vaccine in healthy adolescents in India. Pediatr Infect Dis J 26 11 (2007) 1038-1041
18. Velu V., Nandakumar S., Shanmugam S., Jadhav S.S., Kulkarni P.S., and Thyagarajan S.P. Comparison of three different recombinant hepatitis B vaccines: GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India. World J Gastroenterol 13 22 (2007) 3084-3089
19. UniProtKB/Swiss-Prot P03141 (HBSAG_HBVA3). http://www.uniprot.org/uniprot/P03141 [accessed 23.11.09].
20. Hollinger F.B., Adam F., Heiberg D., and Melnick JL. Response to hepatitis B vaccine in young adult population (1982), Franklin Institute Press, Philadelphia, PA p. 451-66
21. Farrington C.P., and Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 9 12 (1990) 1447-1454
22. Halsey N.A., Moulton L.H., O'Donovan J.C., Walcher J.R., Thoms M.L., Margolis H.S., et al. Hepatitis B vaccine administered to children and adolescents at yearly intervals. Pediatrics 103 6 Pt 1 (1999) 1243-1247
23. Keating G.M., and Noble S. Recombinant hepatitis B vaccine (Engerix-B): a review of its immunogenicity and protective efficacy against hepatitis B. Drugs 63 10 (2003) 1021-1051
24. Schiff G.M., Sherwood J.R., Zeldis J.B., and Krause D.S. Comparative study of the immunogenicity and safety of two doses of recombinant hepatitis B vaccine in healthy adolescents. J Adolesc Health 16 1 (1995) 12-17
25. Rustgi V.K., Schleupner C.J., and Krause D.S. Comparative study of the immunogenicity and safety of Engerix-B administered at 0, 1, 2 and 12 months and Recombivax HB administered at 0, 1, and 6 months in healthy adults. Vaccine 13 17 (1995) 1665-1668
26. Andre F.E. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 87 3A (1989) 14S-20S
27. Wood R.C., MacDonald K.L., White K.E., Hedberg C.W., Hanson M., and Osterholm M.T. Risk factors for lack of detectable antibody following hepatitis B vaccination of Minnesota health care workers. JAMA 270 24 (1993) 2935-2939
28. Floreani A., Baldo V., Cristofoletti M., Renzulli G., Valeri A., Zanetti C., et al. Long-term persistence of anti-HBs after vaccination against HBV: an 18 year experience in health care workers. Vaccine 22 5-6 (2004) 607-610
29. Lu C.Y., Chiang B.L., Chi W.K., Chang M.H., Ni Y.H., Hsu H.M., et al. Waning immunity to plasma-derived hepatitis B vaccine and the need for boosters 15 years after neonatal vaccination. Hepatology 40 6 (2004) 1415-1420
30. Grotto I., Mandel Y., Ephros M., Ashkenazi I., and Shemer J. Major adverse reactions to yeast-derived hepatitis B vaccines - a review. Vaccine 16 4 (1998) 329-334