Comparison of four recombinant hepatitis B vaccines applied on an accelerated schedule in healthy adults

Human Vaccines

Volumn 7, Issue 10, 2011, Pages 1026-1036

  Hernández Bernal, Francisco ^a   Aguilar Betancourt, Ariśtides ^b   Aljovin, Virginia ^c   Arias, Gloria ^c   Valenzuela, Carmen ^a   Pérez De Alejo, Karen ^b   Hernández, Karina ^c   Oquendo, Orcilia ^c   Figueredo, Niurka ^c   Figueroa, Nelvis ^b   Musacchio, Alexis ^b   Véliz, Gloria ^b   García, Elizeth ^a   Mollineda, Alina D ^e   Juvier, Ana Isabel ^d   Trujillo, Janette ^d   Delahanty, Aurora ^d   Ortega, D ^d   Cinza, Z ^b   Muzio González, Verena L ^b  

^a Center for Biologicals Research   (Cuba)

^b CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY   (Cuba)

^c Mártires del Corinthia Clinic   (Cuba)

^d National Center for Immunoassay   (Cuba)

^e Marianao Blood Bank   (Cuba)

Author keywords

Clinical trial; HBsAg; Hepatitis B vaccine; Hepatitis B virus; Vaccine immunogenicity

Indexed keywords

HEPATITIS B ANTIBODY; RECOMBINANT HEPATITIS B VACCINE; HEPATITIS B VACCINE;

ADULT; ANTIBODY TITER; ARTICLE; ASTHENIA; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ERYTHEMA; FEMALE; HEPATITIS B; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE PAIN; MALAISE; MALE; NORMAL HUMAN; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SWELLING; TREATMENT RESPONSE; VACCINATION; VOMITING; ADOLESCENT; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; METHODOLOGY; MIDDLE AGED; PHASE 4 CLINICAL TRIAL;

ADOLESCENT; ADULT; DOUBLE-BLIND METHOD; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMAN EXPERIMENTATION; HUMANS; IMMUNIZATION SCHEDULE; IMMUNIZATION, SECONDARY; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; VACCINATION; YOUNG ADULT;

EID: 85045351686     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.7.10.15989     Document Type: Article

References (48)

1. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment and current and emerging prevention and control measures. J Viral Hepat 2004; 11:97-107; PMID:14996343; DOI:10.1046/j.1365-2893.2003.00487.x.
2. Beasley RP, Hwang LY. Overview on the epidemiology of hepatocellular carcinoma. In: Hollinger FB, Lemon SB, Margolis HS, Editors. Viral hepatitis and liver disease. Baltimore: Williams & Wilkins 1991; 532-5.
3. Maynard JE, Kane MA, Alter MJ, Halder SC. Control of hepatitis B by immunization: global perspectives. In: Vyas GN, Dienstag JL, Hoofnagle JH, Editors. Viral hepatitis and liver disease. New York: Grune & Stratton 1988; 967-9.
4. Maddrey WC. Hepatitis B: an important public health issue. J Med Virol 2000; 61:362-6; PMID:10861647; DOI:10.1002/1096-9071(200007)61:3<362:: AIDJMV14>3.0.CO;2-I.
5. McMahon BJ, Bruden DL, Petersen KM, Bulkow LR, Parkinson AJ, Nainan O, et al. Antibody levels of protection after hepatitis B vaccination: results of a 15-year follow-up. Ann Intern Med 2005; 142:333-41; PMID:15738452.
6. Lavanchy D. Worldwide epidemiology of HBV infection, disease burden and vaccine prevention. J Clin Virol 2005; 34:1-3; PMID:16461208; DOI:10.1016/S1386-6532(05)00384-7.
7. Wiegand J, van-Bommel F, Berg T. Management of Chronic Hepatitis B: Status and Challenges beyond Treatment Guidelines. Semin Liver Dis 2010; 30:361- 77; PMID:20960376; DOI:10.1055/s-0030-1267537.
8. Maynard JE, Kane MA, Alter MJ, Hadler SC. Control of Hepatitis B immunization: Global perspective. Viral Hepatitis and Liver Diseases. Zuckermann Aj, Liss AR, Editors, Inc. 1988; 967-9.
9. Huang K, Lin S. Nationwide vaccination: a success story in Taiwan. Vaccine 2000; 18:35-8; PMID:10683542; DOI:10.1016/S0264-410X(99)00460-0.
10. Ni YH, Chen DS. Hepatitis B vaccination in children: the Taiwan experience. Pathol Biol (Paris) 2010; 58:296-300; PMID:20116181; DOI:10.1016/j.patbio.2009.11.002.
11. Andre FE. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 1989; 87:14-20; PMID:2528292; DOI:10.1016/0002- 9343(89)90525-1.
12. Lobaina Y, García D, Iglesias E, Muzio V, Rodríguez D, Gorovaya L, et al. Comparison of the immune response induced in mice by five commercial vaccines based on recombinant HBsAg from different sources, implications on their therapeutic use. Biotecnol Apl 2008; 25:325-31.
13. Hardy E, Martinez E, Diago D, Diaz R, Gonzalez D, Herrera L. Large-scale production of recombinant hepatitis B surface antigen from Pichia pastoris. J Biotechnol 2000; 77:157-67; PMID:10682276; DOI:10.1016/S0168-1656(99)00201-1.
14. Pentón E, Muzio V, González-Griego M. The hepatitis B Virus (HBV) infection and its prevention by a recombinant-DNA viral surface antigen (rec-HBsAg) vaccine. Biotecnol Apl 1997; 11:1-11.
15. Juliao O, González A, Ramírez V, Rojas MC, Boshell J, Hernández LS, et al. Study of the immunogenicity of two recombinant hepatitis B vaccine comparating schedules. Biomédica (Bogotá) 1991; 11:71-83.
16. ul-Haq N, Hasnain SS, Umar M, Abbas Z, Valenzuela C, López-Saura P. Immunogenicity of 10 and 20 μg hepatitis B vaccine in a two-dose schedule. Vaccine 2003; 21:3179-85; PMID:12804846; DOI:10.1016/S0264-410X(03)00232-9.
17. González-Griego M, Cinza Z, Ortega A. Inmunogenicidad de esquemas de dos dosis de Heberbiovac HB. Rev Cubana Med Trop 2001; 50.
18. Shokri F, Jafarzadeh A. High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates. Vaccine 2001; 19:4544-8; PMID:11483282; DOI:10.1016/S0264-410X(01)00183-9.
19. Aguilar-Betancourt A, González CA, Cinza Z, Cabrera J, Véliz 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; PMID:17257877; DOI:10.1016/j.ijid. 2006.09.010.
20. Van Herck K, Leuridan E, Van Damme P. Schedules for hepatitis B vaccination of risk groups: balancing immunogenicity and compliance. Sex Transm Infect 2007; 83:426-32; PMID:17911142; DOI:10.1136/sti.2006.022111.
21. André FE. Overview of a five year clinical experience with a yeast derived hepatitis B vaccine. Vaccine 1990; 8:574-8; DOI:10.1016/0264-410X(90) 90222-8.
22. Anti-HBs UMELISA. Code UM 2023. Immunoassay Center. Feb 5, 2002. See http://www.tecnosuma.com/ Informacion/Inserts/LI-2029-E-102000.pdf, accessed on May 20, 2009.
23. Rendi-Wagner P, Kundi M, Stemberger H, Wiedermann G, Holzmann H, Hofer M, et al. Antibody-response to three recombinant hepatitis B vaccines: comparative evaluation of multicentre travel-clinic based experience. Vaccine 2001; 19:2055-60; PMID:11228377; DOI:10.1016/S0264-410X(00)00410-2.
24. Jilg W, Schmidt M, Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J Infect Dis 1989; 160:766-9; PMID:2530289; DOI:10.1093/infdis/160.5.766.
25. Mast EE, Weinbaum CM, Fiore AE, Alter MJ, Bell BP, Finelli L, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm Rep 2006; 55:1-33; PMID:17159833.
26. McMahon BJ, Bruden DL, Petersen KM, Bulkow LR, Parkinson AJ, et al. Antibody levels and protection after hepatitis B vaccination: results of a 15-year follow-up. Ann Intern Med 2005; 142:333-41; PMID:15738452.
27. McMahon BJ, Dentinger CM, Bruden D, Zanis C, Peters H, Hurlburt D, et al. Antibody levels and protection after hepatitis B vaccine: results of a 22-year follow-up study and response to a booster dose. J Infect Dis 2009; 200:1390-6; PMID:19785526; DOI:10.1086/606119.
28. Pedroso P, Díaz M, Rodríguez L. Inmunogenicidad de la vacuna HEBERBIOVAC HB en ancianos. Rev Cubana Med Trop 1996; 48:58-60.
29. Montalvo MC, Delgado G, Díaz M, Bali A, Bello M, Gutiérrez A, et al. Evaluación de la respuesta humoral a la vacuna Heberbiovac HB en pacientes hemodializados de Ciudad de La Habana. Rev Biomed 2010; 21:5-12.
30. Cassidy WM, Watson B, Ioli VA, Williams K, Bird S, West DJ. A randomized trial of alternative twoand three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety and immunologic memory. Pediatrics 2001; 107:626-31; PMID:11335734; DOI:10.1542/peds.107.4.626.
31. Coates T, Wilson R, Patrick G, Andre F, Watson V. Hepatitis B vaccines: assessment of the seroprotective efficacy of two recombinant DNA vaccines. Clin Ther 2001; 23:392-403; PMID:11318074; DOI:10.1016/S0149-2918(01)80044-8.
32. Leroux-Roels G, Abraham B, Fourneau M, De Clercq N, Safary A. A comparison of two commercial recombinant vaccines for hepatitis B in adolescents. Vaccine 2000; 19:937-42; PMID:11115719; DOI:10.1016/S0264-410X(00) 00217-6.
33. Keating GM, Noble S. Recombinant hepatitis B vaccine (Engerix-B): a review of its immunogenicity and protective efficacy against hepatitis B. Drugs 2003; 63:1021- 51; PMID:12699402; DOI:10.2165/00003495-200363100-00006.
34. Sitrin RD, Wampler DE, Ellis RW. Survey of licensed hepatitis B vaccines and their production processes. In: Ellis RW, Editor. Hepatitis B vaccines in clinical practice. New York: Marcel Dekker 1993; 83-101.
35. Tleugabulova D, Falcon V, Sewer M, Penton E. Aggregation of recombinant hepatitis B surface antigen in Picchia pastoris. J Chromatogr B Analyt Technol Biomed Life Sci 1998; 716:209-19; DOI:10.1016/S0378-4347(98)00297-7.
36. Kobayashi M, Asano T, Utsunomiya M, Itoh Y, Fujisawa Y, Nishimura O, et al. The oligosaccharides in a recombinant hepatitis B virus surface antigen (HBsAg) carrying the pre-S2 region derived from yeast. FEBS Lett 1992; 302:129-32; PMID:1633844; DOI:10.1016/0014-5793(92)80422-D.
37. Vanlandschoot P, Van Houtte F, Roobrouck A, Farhoudi A, Stelter F, Peterson DL, et al. LPS-binding protein and CD14-dependent attachment of hepatitis B surface antigen to monocytes is determined by the phospholipid moiety of the particles. J Gen Virol 2002; 83:2279-89; PMID:12185283.
38. Vanlandschoot P, Roobrouck A, Van Houtte F, Leroux- Roels G. Recombinant HBsAg, an apoptotic-like lipoprotein, interferes with the LPS-induced activation of ERK-1/2 and JNK-1/2 in monocytes. Biochem Biophys Res Commun 2002; 297:486-91; PMID:12270119; DOI:10.1016/S0006-291X(02)02243-X.
39. Vanlandschoot P, Van Houtte F, Hoek F, Nieuwland R, Leroux-Roel G. Saccharomyces cerevisiae-derived HBsAg preparations differ in their attachment to monocytes, immune-suppressive potential and T-cell immunogenicity. J Med Virol 2003; 70:513-9; PMID:12794712; DOI:10.1002/jmv.10425.
40. David N, Fisman, Agrawal D, Leder K. The Effect of Age on Immunologic Response to Recombinant Hepatitis B Vaccine: A Meta-analysis. Clin Infect Dis 2002; 35:1368-75; PMID:12439800; DOI:10.1086/344271.
41. Weber DJ, Rutala WA, Samsa GP, Santimaw JE, Lemon SM. Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine. JAMA 1985; 254:3187-489; PMID:2933532; DOI:10.1001/jama.254.22.3187.
42. Shaw FE Jr, Guess HA, Roets JM, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 1989; 7:425-30; PMID:2530717; DOI:10.1016/0264-410X(89)90157-6.
43. Averhoff F, Mahoney F, Coleman P, Schatz G, Hurwitz E, Margolis H. Immunogenicity of hepatitis B vaccines. Implications for persons at occupational risk of hepatitis B virus infection. Am J Prev Med 1998; 15:1-8; PMID:9651632; DOI:10.1016/S0749-3797(98)00003-8.
44. Hennig BJ, Fielding K, Broxholme J, Diatta M, Mendy M, Moore C, et al. Host Genetic Factors and Vaccine-Induced Immunity to Hepatitis B Virus Infection. PLoS ONE 2008; 3:1-10; PMID:18365030; DOI:10.1371/journal.pone. 0001898.
45. DeRave S, Heijtink RA, Bakker-Bendik M, Boot J, Schalm SW. Immunogenicity of standard and low dose vaccination using yeast-derived recombinant hepatitis B surface antigen in elderly volunteers. Vaccine 1994; 12:532-4; PMID:8036828; DOI:10.1016/0264-410X(94)90313-1.
46. Estévez ZC, Betancourt AA, González VM, Baile NF, Silva CV, Bernal FH, et al. Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults. Biologicals 2007; 35:115-22; PMID:17056272; DOI:10.1016/j.biologicals.2006.06.001.
47. Froehlich H, West DJ. Compliance with hepatitis B virus vaccination in a high-risk population. Ethn Dis 2001; 11:548-53; PMID:11572420.
48. HBsAg UMELISA. Code UM BA96042. Immunoassay Center. Feb 5, 2002. See http://www.tecnosuma.com/Informacion/Manuales/Software/Manual-SMCCEvaluador.pdf, accessed on May 20, 2009.