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Volumn 35, Issue 2, 2007, Pages 115-122

Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults

(21)  Estévez, Zurina Cinza a   Betancourt, Arístides Aguilar a   González, Verena Muzio a   Baile, Nelvis Figueroa a   Silva, Carmen Valenzuela b   Bernal, Francisco Hernández b,e   Arias, Eduardo Pentón a   Fernández, Aurora Delhanty c   Olazábal, Nelia Martin d   Amaurys del Rio Martin b   Batista, Lester Leal b   Ríos, Gloria Véliz a   Hernández, Héctor Hernández a   Hernández, Aracelis Blanco d   Lugo, Evelyn Pérez d   Joel de la Torre Cruz, d   Batista Marchec, Bertha L d   Leovaldo Alvarez Falcon b   Brito, Jannet Trujillo c   León, Darién Ortega c   more..


Author keywords

Clinical trial; Immunogenicity; Recombinant hepatitis B vaccine; Safety

Indexed keywords

HEBERBIOVAC HB; HEPATITIS B SURFACE ANTIGEN; PLACEBO; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG;

EID: 33947321915     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2006.06.001     Document Type: Article
Times cited : (38)

References (49)
  • 1
    • 0031021442 scopus 로고    scopus 로고
    • Vaccines to prevent viral hepatitis
    • Lemon S.M., and Thomas D.L. Vaccines to prevent viral hepatitis. N Engl J Med 16 (1997) 196-204
    • (1997) N Engl J Med , vol.16 , pp. 196-204
    • Lemon, S.M.1    Thomas, D.L.2
  • 2
    • 0033588461 scopus 로고    scopus 로고
    • Over a decade of experience with a yeast recombinant hepatitis B vaccine
    • Safary A., and André F. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine 18 (1999) 57-67
    • (1999) Vaccine , vol.18 , pp. 57-67
    • Safary, A.1    André, F.2
  • 3
    • 0029115078 scopus 로고
    • Global programme for control of hepatitis B infection
    • Kane M. Global programme for control of hepatitis B infection. Vaccine 13 Suppl. 1 (1995) S47-S49
    • (1995) Vaccine , vol.13 , Issue.SUPPL. 1
    • Kane, M.1
  • 4
    • 33947302539 scopus 로고    scopus 로고
    • Superior efficacy of Shanvac-B as a Hepatitis B vaccine in dialysis dependent patients
    • Jha R., Lakhtakia S., Narayan G., and Hemlath K. Superior efficacy of Shanvac-B as a Hepatitis B vaccine in dialysis dependent patients. Ind J Nephrol 11 (Oct-Dec 2001) 170-172
    • (2001) Ind J Nephrol , vol.11 , pp. 170-172
    • Jha, R.1    Lakhtakia, S.2    Narayan, G.3    Hemlath, K.4
  • 5
    • 0037866956 scopus 로고    scopus 로고
    • Immunogenicity of 10 and 20 microgram hepatitis B vaccine in a two-dose schedule
    • ul-Haq N., Hasnain S.S., Umar M., Abbas Z., Valenzuela-Silva C., and Lopez-Saura P. Immunogenicity of 10 and 20 microgram hepatitis B vaccine in a two-dose schedule. Vaccine 21 23 (2003 Jul 4) 3179-3185
    • (2003) Vaccine , vol.21 , Issue.23 , pp. 3179-3185
    • ul-Haq, N.1    Hasnain, S.S.2    Umar, M.3    Abbas, Z.4    Valenzuela-Silva, C.5    Lopez-Saura, P.6
  • 6
    • 0343314905 scopus 로고    scopus 로고
    • Large-scale production of recombinant hepatitis B surface antigen from Pichia pastoris
    • Hardy E., Martinez E., Diago D., Diaz R., Gonzalez D., and Herrera L. Large-scale production of recombinant hepatitis B surface antigen from Pichia pastoris. J Biotechnol 77 2-3 (2000 Feb 17) 157-167
    • (2000) J Biotechnol , vol.77 , Issue.2-3 , pp. 157-167
    • Hardy, E.1    Martinez, E.2    Diago, D.3    Diaz, R.4    Gonzalez, D.5    Herrera, L.6
  • 7
    • 0032233802 scopus 로고    scopus 로고
    • A comparative study between different regimens for administering 2 doses of the Cuban anti-hepatitis B vaccine
    • Gonzalez-Griego Mde J., Cinza Z., Ortega A., Gali M.M., Santoyo M.E., Garcia G., et al. A comparative study between different regimens for administering 2 doses of the Cuban anti-hepatitis B vaccine. Rev Cubana Med Trop 50 3 (1998) 218-220
    • (1998) Rev Cubana Med Trop , vol.50 , Issue.3 , pp. 218-220
    • Gonzalez-Griego Mde, J.1    Cinza, Z.2    Ortega, A.3    Gali, M.M.4    Santoyo, M.E.5    Garcia, G.6
  • 9
    • 0034518927 scopus 로고    scopus 로고
    • Impact of an anti-hepatitis B virus (HBV) immunization program in patients undergoing dialysis in Havana, Cuba
    • Gonzalez-Griego M., Penton E., Delgado G., Perez-Oliva J., Ramos V., Izquierdo M., et al. Impact of an anti-hepatitis B virus (HBV) immunization program in patients undergoing dialysis in Havana, Cuba. Invest Clin 41 4 (2000 Dec) 237-244
    • (2000) Invest Clin , vol.41 , Issue.4 , pp. 237-244
    • Gonzalez-Griego, M.1    Penton, E.2    Delgado, G.3    Perez-Oliva, J.4    Ramos, V.5    Izquierdo, M.6
  • 10
    • 0035859980 scopus 로고    scopus 로고
    • High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates
    • Shokri F., and Jafarzadeh A. High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates. Vaccine 19 31 (2001 Aug 14) 4544-4548
    • (2001) Vaccine , vol.19 , Issue.31 , pp. 4544-4548
    • Shokri, F.1    Jafarzadeh, A.2
  • 12
    • 33947331326 scopus 로고    scopus 로고
    • Training manual on the critical regulatory functions for vaccines: evaluation of clinical performance through authorized clinical trials
    • Training manual on the critical regulatory functions for vaccines: evaluation of clinical performance through authorized clinical trials. WHO/V&B/03.12 (June 2003). www.who.int/vaccines-documents/
    • (2003) WHO/V&B/03.12
  • 13
    • 33947305403 scopus 로고    scopus 로고
    • Topic Q5E, Step 4 Note for guidance on biotechnological/biological products subject to changes in their manufacturing process (CPMP7ICH/5721/03 final approval by CHMP December 2004). www.emea.eu.int/pdfs/human/ich/572103en.pdf.
  • 14
    • 33947315249 scopus 로고    scopus 로고
    • Guidelines on clinical evaluation of vaccines: regulatory expectations. In: Annex 1. WHO GUIDELINES ON NONCLINICAL EVALUATION OF VACCINES. Adopted by the 54th meeting of the WHO Expert Committee on Biological Standardization, 17-21 November 2003. WHO Technical Report Series No. 924, 2004. www.who.int/biologicals/publications/nonclinical evolution vaccines nov 2003.pdf.
  • 15
    • 33947318921 scopus 로고    scopus 로고
    • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CPMP/BWP/3097/02/final approval by CPMP December 2003). http://www.emea.eu.int/pdfs/human/ewp/309702en.pdf.
  • 16
    • 33947317705 scopus 로고    scopus 로고
    • Guideline on comparability of medicinal product containing biotechnology-derived proteins as active substance: quality issues (EMEA/CPMP/BWP/3201/00/Rev1 2003). http://www.emea.eu.int/pdfs/human/bwp/320700en.pdf.
  • 18
    • 33947306242 scopus 로고    scopus 로고
    • World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964. Amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. http://www.seeiuc.com/investig/helsinki.htm.
  • 20
    • 0030310546 scopus 로고    scopus 로고
    • Validación de un ultramicroELISA de detección de anticuerpos contra el antígeno de superficie de la hepatitis B.
    • enero-abril
    • Rodríguez L., Balmaseda A., Bravo J., Trujillo J., Martínez L., Ochoa R., et al. Validación de un ultramicroELISA de detección de anticuerpos contra el antígeno de superficie de la hepatitis B. Rev Cubana Med Trop 48 1 (1996) 45-49 enero-abril
    • (1996) Rev Cubana Med Trop , vol.48 , Issue.1 , pp. 45-49
    • Rodríguez, L.1    Balmaseda, A.2    Bravo, J.3    Trujillo, J.4    Martínez, L.5    Ochoa, R.6
  • 21
    • 0025211412 scopus 로고
    • Overview of a five-year clinical experience with a yeast derived hepatitis B vaccine
    • André F.E. Overview of a five-year clinical experience with a yeast derived hepatitis B vaccine. Vaccine 8 6 (1990) 574-578
    • (1990) Vaccine , vol.8 , Issue.6 , pp. 574-578
    • André, F.E.1
  • 22
    • 33947326389 scopus 로고    scopus 로고
    • Engerix-B. Belgium: SmithKline Beecham Pharmaceuticals, 1995 (package insert).
  • 23
    • 0002170114 scopus 로고
    • The hepatitis B Virus (HBV) infection and its prevention by a recombinant-DNA viral surface antigen (rec-HBsAg) vaccine
    • Pentón E., Muzio V., and González Griego M. The hepatitis B Virus (HBV) infection and its prevention by a recombinant-DNA viral surface antigen (rec-HBsAg) vaccine. Biotecnología Aplicada 11 1 (1994) 1-11
    • (1994) Biotecnología Aplicada , vol.11 , Issue.1 , pp. 1-11
    • Pentón, E.1    Muzio, V.2    González Griego, M.3
  • 24
    • 0027158733 scopus 로고
    • Pediatric experience with recombinant hepatitis B vaccines and relevant safety and immunization studies
    • Greenberg D.P. Pediatric experience with recombinant hepatitis B vaccines and relevant safety and immunization studies. Pedriat Infect Dis J 12 (1993) 438-445
    • (1993) Pedriat Infect Dis J , vol.12 , pp. 438-445
    • Greenberg, D.P.1
  • 27
    • 0022749830 scopus 로고
    • Overview of clinical studies with hepatitis B vaccine made by recombinant DNA
    • Zajac B.A., West D.J., McAleer W.J., and Scolnick E.M. Overview of clinical studies with hepatitis B vaccine made by recombinant DNA. J Infect 13 Suppl. A (1986) 39-45
    • (1986) J Infect , vol.13 , Issue.SUPPL. A , pp. 39-45
    • Zajac, B.A.1    West, D.J.2    McAleer, W.J.3    Scolnick, E.M.4
  • 28
    • 0018956669 scopus 로고
    • Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high risk population in the United States
    • Szmuness W., Stevens C.E., Harley E.J., Zang E.A., Oleszko W.R., William D.C., et al. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high risk population in the United States. N Engl J Med 303 (1980) 833-841
    • (1980) N Engl J Med , vol.303 , pp. 833-841
    • Szmuness, W.1    Stevens, C.E.2    Harley, E.J.3    Zang, E.A.4    Oleszko, W.R.5    William, D.C.6
  • 29
    • 0019949818 scopus 로고
    • Prevention of hepatitis B vaccine: report from the centers for Disease Control multicenter efficacy trial among homosexual men
    • Francis D.P., Halder S.C., Thompson S.E., Maynard J.E., Ostrow D.G., Altman N., et al. Prevention of hepatitis B vaccine: report from the centers for Disease Control multicenter efficacy trial among homosexual men. Ann Intern Med 97 (1982) 362-366
    • (1982) Ann Intern Med , vol.97 , pp. 362-366
    • Francis, D.P.1    Halder, S.C.2    Thompson, S.E.3    Maynard, J.E.4    Ostrow, D.G.5    Altman, N.6
  • 30
    • 0029418318 scopus 로고
    • Reactogenicidad de la vacuna HEBERBIOVAC HB a diferentes dosis
    • Díaz M., Navia O., Bravo J., Pedroso P., and Urbino A. Reactogenicidad de la vacuna HEBERBIOVAC HB a diferentes dosis. Re Cub Med Trop 47 1 (1995) 65-70
    • (1995) Re Cub Med Trop , vol.47 , Issue.1 , pp. 65-70
    • Díaz, M.1    Navia, O.2    Bravo, J.3    Pedroso, P.4    Urbino, A.5
  • 31
    • 0033644268 scopus 로고    scopus 로고
    • A multicentric evaluation of recombinant DNA hepatitis B vaccine of Cuban origin
    • Jain A., Mathur U.S., Jandwani P., Gupta R.K., Kumar V., and Kar P. A multicentric evaluation of recombinant DNA hepatitis B vaccine of Cuban origin. Trop Gastroenterol 21 1 (2000 Jan-Mar) 14-17
    • (2000) Trop Gastroenterol , vol.21 , Issue.1 , pp. 14-17
    • Jain, A.1    Mathur, U.S.2    Jandwani, P.3    Gupta, R.K.4    Kumar, V.5    Kar, P.6
  • 32
    • 0027786892 scopus 로고
    • A comparative evaluation of the immunogenicity and reactogenicity of recombinant vaccines against hepatitis B.
    • Gorbunov M.A., Pavlova L.I., Noslova A.V., Ikoev V.N., Bektimirov T.A., Voitenkov M.M., et al. A comparative evaluation of the immunogenicity and reactogenicity of recombinant vaccines against hepatitis B. Vopr Virusol 38 5 (1993 Sep-Dec) 216-218
    • (1993) Vopr Virusol , vol.38 , Issue.5 , pp. 216-218
    • Gorbunov, M.A.1    Pavlova, L.I.2    Noslova, A.V.3    Ikoev, V.N.4    Bektimirov, T.A.5    Voitenkov, M.M.6
  • 33
    • 0037019882 scopus 로고    scopus 로고
    • A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart
    • Heron L.G., Chant K.G., and Jalaludin B.B. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine 20 29-30 (2002 Oct 4) 3472-3476
    • (2002) Vaccine , vol.20 , Issue.29-30 , pp. 3472-3476
    • Heron, L.G.1    Chant, K.G.2    Jalaludin, B.B.3
  • 34
    • 0031727928 scopus 로고    scopus 로고
    • Vaccination against hepatitis B
    • S111-4
    • Desgrandchamps D., and Siegrist C.A. Vaccination against hepatitis B. Soz Praventivmed 43 Suppl. 1 (1998) S37-S40 S111-4
    • (1998) Soz Praventivmed , vol.43 , Issue.SUPPL. 1
    • Desgrandchamps, D.1    Siegrist, C.A.2
  • 35
    • 0021153379 scopus 로고
    • Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy
    • Dienstag J.L., Werner B.G., Polk B.F., Snydman D.R., Craven D.E., Platt R., et al. Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy. Ann Intern Med 101 1 (1984 Jul) 34-40
    • (1984) Ann Intern Med , vol.101 , Issue.1 , pp. 34-40
    • Dienstag, J.L.1    Werner, B.G.2    Polk, B.F.3    Snydman, D.R.4    Craven, D.E.5    Platt, R.6
  • 36
    • 0034966731 scopus 로고    scopus 로고
    • Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination
    • Young M.D., Gooch III W.M., Zuckerman A.J., Du W., Dickson B., and Maddrey W.C. Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination. J Med Virol 64 3 (2001 Jul) 290-298
    • (2001) J Med Virol , vol.64 , Issue.3 , pp. 290-298
    • Young, M.D.1    Gooch III, W.M.2    Zuckerman, A.J.3    Du, W.4    Dickson, B.5    Maddrey, W.C.6
  • 37
    • 0036841343 scopus 로고    scopus 로고
    • The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population
    • Jacques P., Moens G., Desombere I., Dewijngaert J., Leroux-Roels G., Wettendorff M., et al. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine 20 31-32 (2002 Nov 1) 3644-3649
    • (2002) Vaccine , vol.20 , Issue.31-32 , pp. 3644-3649
    • Jacques, P.1    Moens, G.2    Desombere, I.3    Dewijngaert, J.4    Leroux-Roels, G.5    Wettendorff, M.6
  • 38
    • 0035150444 scopus 로고    scopus 로고
    • Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children
    • De Serres G., Duval B., Boulianne N., Rochette M., Dionne M., Fradet M.D., et al. Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children. Am J Public Health 91 2 (2001 Feb) 313-315
    • (2001) Am J Public Health , vol.91 , Issue.2 , pp. 313-315
    • De Serres, G.1    Duval, B.2    Boulianne, N.3    Rochette, M.4    Dionne, M.5    Fradet, M.D.6
  • 40
    • 0043097209 scopus 로고    scopus 로고
    • Philippe Duclos. Safety of immunisation and adverse events following vaccination against hepatitis B. 226
    • Philippe Duclos. Safety of immunisation and adverse events following vaccination against hepatitis B. 226. Expert Opin Drug Saf 2 3 (2003) 225-231
    • (2003) Expert Opin Drug Saf , vol.2 , Issue.3 , pp. 225-231
  • 41
    • 12644256602 scopus 로고    scopus 로고
    • Biological parameters influencing the immunological response to plasma derived and recombinant hepatitis B vaccines
    • Honorati M.C., Mariani E., Dolzani P., and Facchini A. Biological parameters influencing the immunological response to plasma derived and recombinant hepatitis B vaccines. Ann Ist Super Sanita 32 3 (1996) 369-374
    • (1996) Ann Ist Super Sanita , vol.32 , Issue.3 , pp. 369-374
    • Honorati, M.C.1    Mariani, E.2    Dolzani, P.3    Facchini, A.4
  • 43
    • 0027964485 scopus 로고
    • Effect of age on the immunogenicity of yeast recombinant hepatitis B vaccines containing surface antigen (S) or preS2 + S antigens
    • Clements M.L., Miskovsky E., Davidson M., Cupps T., Kumwenda N., Sandman L.A., et al. Effect of age on the immunogenicity of yeast recombinant hepatitis B vaccines containing surface antigen (S) or preS2 + S antigens. J Infect Dis 170 3 (1994) 510-516
    • (1994) J Infect Dis , vol.170 , Issue.3 , pp. 510-516
    • Clements, M.L.1    Miskovsky, E.2    Davidson, M.3    Cupps, T.4    Kumwenda, N.5    Sandman, L.A.6
  • 44
    • 0027144458 scopus 로고
    • Risk factors for lack of detectable antibody following hepatitis B vaccination of Minnesota health workers
    • 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 workers. JAMA 270 (1993) 2935-2939
    • (1993) JAMA , vol.270 , pp. 2935-2939
    • Wood, R.C.1    MacDonald, K.L.2    White, K.E.3    Hedberg, C.W.4    Hanson, M.5    Osterholm, M.T.6
  • 45
    • 6544281580 scopus 로고    scopus 로고
    • Factors associated with inadequate response to hepatitis B vaccination in health care personnel
    • Tolosa N., Tenias J.M., Perez B., and Bautista J. Factors associated with inadequate response to hepatitis B vaccination in health care personnel. Rev Esp Salud Publica 72 6 (1998 Nov-Dec) 509-515
    • (1998) Rev Esp Salud Publica , vol.72 , Issue.6 , pp. 509-515
    • Tolosa, N.1    Tenias, J.M.2    Perez, B.3    Bautista, J.4
  • 46
    • 0024465239 scopus 로고
    • Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination
    • Shaw Jr. F.E., Guess H.A., Roets J.M., Mohr F.E., Coleman P.J., Mandel E.J., et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 7 5 (1989) 425-430
    • (1989) Vaccine , vol.7 , Issue.5 , pp. 425-430
    • Shaw Jr., F.E.1    Guess, H.A.2    Roets, J.M.3    Mohr, F.E.4    Coleman, P.J.5    Mandel, E.J.6
  • 47
    • 12644258547 scopus 로고    scopus 로고
    • Age-related hepatitis B seroconversion rates in health care workers
    • Havlichek Jr. D., Rosenman K., Simms M., and Guss P. Age-related hepatitis B seroconversion rates in health care workers. Am J Infect Control 25 5 (1997 Oct) 418-420
    • (1997) Am J Infect Control , vol.25 , Issue.5 , pp. 418-420
    • Havlichek Jr., D.1    Rosenman, K.2    Simms, M.3    Guss, P.4
  • 48
    • 0030845807 scopus 로고    scopus 로고
    • Efficacy of a high and accelerated dose of hepatitis B vaccine in alcoholic patients: a randomized clinical trial
    • Rosman A.S., Basu P., Galvin K., and Lieber C.S. Efficacy of a high and accelerated dose of hepatitis B vaccine in alcoholic patients: a randomized clinical trial. Am J Med 103 3 (1997 Sep) 217-222
    • (1997) Am J Med , vol.103 , Issue.3 , pp. 217-222
    • Rosman, A.S.1    Basu, P.2    Galvin, K.3    Lieber, C.S.4
  • 49
    • 84944370149 scopus 로고
    • Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine
    • Weber D.J., Rutala W.A., Samsa G.P., Santimaw J.E., and Lemon S.M. Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine. JAMA 254 (1985) 3187-3189
    • (1985) JAMA , vol.254 , pp. 3187-3189
    • Weber, D.J.1    Rutala, W.A.2    Samsa, G.P.3    Santimaw, J.E.4    Lemon, S.M.5


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