Antibody response to heat-inactivated hepatitis B vaccine (CLB-3mg) in hemodialysis patients and occupational risk personnel: a one year follow-up

Yoshida, C. F. T.; Takahashi, C.; Mercadante, L. A. C.; Camargo, I. F.

doi:10.1590/S0036-46651988000100002

Abstracts

Immune response against hepatitis B vaccine (CLB 3mg) was evaluated in 59 hemodialysis patients and 20 occupational risk personnel. Seroconversion was induced in 52.5% and 70.0% respectively. Twelve months after the first dose, 37.5% of patients and 60.0% of occupational risk personnel had detectable anti-HBs level. Antibody level was expressed in sample ratio units (SRU). Considering only the responders, in the patients group 38.7% had a low anti-HBs response (2.1-9.9 SRU) 32.3% a medium response (10-99.9 SRU) and 29.0% a high response (>100 SRU) while in occupational risk personnel these values were 14.3%, 64.3% and 21.4% respectively. The authors suggest the use of HBV vaccines with more elevated HBsAg concentration or a reinforced immunization schedule to improve the anti-HBs response not only for patients but also for healthy persons.

Hepatitis B vaccine; Immune Response; Hemodialysis

A resposta imune contra vacina de hepatite B (CLB-3mg) foi avaliada em 59 pacientes de hemodiálise e 20 funcionários de risco em adquirir infecção. A soroconversão foi observada em 52,5% e 70,0%, respectivamente. Um ano após a primeira dose, os níveis de anticorpos anti-HBs foram determinados em 37.5% dos pacientes e 60.0% dos funcionários. Os níveis de anticorpos foram expressos em unidades de radioimunoensaio (SRU = contagem da amostra sobre o controle negativo). Considerando apenas os indivíduos que responderam à vacina, no grupo de pacientes, 38.7% tiveram resposta baixa de anticorpos (2,1 - 9,9 SRU), 32,3% resposta média e 29,0% uma resposta elevada (> SRU), enquanto que no pessoal de risco, os valores foram 14,3%, 64,3% e 21.4%, respectivamente. Os autores sugerem o uso de vacinas de HBV com concentrações de HBsAg mais elevada ou um reforço no esquema de imunização para melhorar a resposta de anti-HBs, não só para pacientes como também para pessoas sadias.

ORIGINAL ARTICLES

Antibody response to heat-inactivated hepatitis B vaccine (CLB-3mg) in hemodialysis patients and occupational risk personnel: a one year follow-up

Resposta de anticorpo contra vacina de hepatite Binativada pelo calor (CLB-3mg) em pacientes de hemodiálise e pessoal de risco: acompanhamento de um ano

C. F. T. Yoshida^I; C. Takahashi^II; L. A. C. Mercadante^I; I. F. Camargo^III; H. G. Schatzmayr^I

^IDepartamento de Virologia. Fundação Oswaldo Cruz, Rio de Janeiro, Brazil

^IICDR - Clínica de Doenças Renais, Rio de Janeiro

^IIIBio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil

^{Address for correspondence} Address for correspondence: Clara Fumiko Tachibana Yoshida Fundação Oswaldo Cruz Departamento de Virologia Av. Brasil, 4365 CEP 21040 Rio de Janeiro, RJ., Brasil

SUMMARY

Immune response against hepatitis B vaccine (CLB 3mg) was evaluated in 59 hemodialysis patients and 20 occupational risk personnel. Seroconversion was induced in 52.5% and 70.0% respectively. Twelve months after the first dose, 37.5% of patients and 60.0% of occupational risk personnel had detectable anti-HBs level. Antibody level was expressed in sample ratio units (SRU). Considering only the responders, in the patients group 38.7% had a low anti-HBs response (2.1-9.9 SRU) 32.3% a medium response (10-99.9 SRU) and 29.0% a high response (>100 SRU) while in occupational risk personnel these values were 14.3%, 64.3% and 21.4% respectively. The authors suggest the use of HBV vaccines with more elevated HBsAg concentration or a reinforced immunization schedule to improve the anti-HBs response not only for patients but also for healthy persons.

Key words: Hepatitis B vaccine; Immune Response; Hemodialysis.

RESUMO

A resposta imune contra vacina de hepatite B (CLB-3mg) foi avaliada em 59 pacientes de hemodiálise e 20 funcionários de risco em adquirir infecção. A soroconversão foi observada em 52,5% e 70,0%, respectivamente. Um ano após a primeira dose, os níveis de anticorpos anti-HBs foram determinados em 37.5% dos pacientes e 60.0% dos funcionários. Os níveis de anticorpos foram expressos em unidades de radioimunoensaio (SRU = contagem da amostra sobre o controle negativo). Considerando apenas os indivíduos que responderam à vacina, no grupo de pacientes, 38.7% tiveram resposta baixa de anticorpos (2,1 - 9,9 SRU), 32,3% resposta média e 29,0% uma resposta elevada (> SRU), enquanto que no pessoal de risco, os valores foram 14,3%, 64,3% e 21.4%, respectivamente. Os autores sugerem o uso de vacinas de HBV com concentrações de HBsAg mais elevada ou um reforço no esquema de imunização para melhorar a resposta de anti-HBs, não só para pacientes como também para pessoas sadias.

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Recebido para publicação em 18/8/1987.

1. BENHAMOU, E., COUROUCÊ, A. M.; JUNGERS, D.; LAPLANCHE, A.; DEGOS, F.; BRANGIER, J. & CROSNIER, J. - Hepatitis B vaccine: randomized trial of immunogenicity in hemodialysis patients. Clin. Nephrol., 21: 143-147, 1984.
2. BRUMMELHUIS, H. G. J.; WILSON-DE-STURLER, L. A. & KAAP, A. K. - Preparation of hepatitis B vaccine by heat inactivation. In: MAUPAS, P. & GUESRY, P., ed. Hepatitis vaccine Amsterdam, Elsevier/North-Holland Biomedical Press, 1981. p. 51 56. (INSERM Simposium nş 18).
3. CAMARGO, I. F.; GASPAR, A. M. C. & YOSHIDA, C. F. T. - Comparative ELISA reagents for detection of hepatitis B surface antigen (HBsAg). Mem. Inst. Oswaldo Cruz, 82: 181-187, 1987.
4. COUROUCÉ, A. M.; JUNGERS, P.; BENHAMOU, E.; LAPLANCHE, A. & CROSNIER, J. - Hepatitis B vaccine in dialysis patients. New Engl. J. Med., 311: 1515-1516, 1984.
5. COUTINHO, R. A.; LELIE, P. N. & ALBRECHT VAN LENT, P. - The efficacy of a heat inactivated hepatitis B vaccine in male homosexuals; outcome of a placebo controlled double blind trial. Brit. med. J., 286: 1305-1308, 1983.
6. CROSNIER, J.; JUNGERS, P.; COUROUCÊ, A. M.; LAPLANCHE, A.; BENHAMOU, E.; DEGOS, F.; LACOUR, B ; PRUNET, P.; CERISIER, Y. & GUESRY, P. - Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in French haemodialysis units. I. Medical Staff. Lancet, 1: 455-459, 1981.
7. CROSNIER, J.; JUNGERS, P ; COUROUCÊ, A. M.; LAPLANCHE, A.; BENHAMOU, E.; DEGOS, F.; LACOUR, B.; PRUNET, P.; CERISIER, Y. & GUESRY, P. - Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in French haemodialysis units. II. Hemodialysis patients. Lancet, 1: 797-800, 1981.
8. DESMYTER, J.; COLAERJ, J.; GROOTE, G REYNDERS, M. & REERINK-BRONGERS, E. E. - Efficacy of heat inactivated hepatitis B vaccine in haemodialysis patients and staff: double blind, placebo controled trial. Lancet, 2: 1323-1327, 1983.
9. DESMYTER, J.; COLAERT, J.; GROOTE, G.; REYNDERS, M.; REERINK-BRONGERS, E. E.; LELIE, P. N.; DEES, P. J.; REESINK, H. W. & LEUVEN RENAL TRANSPLANTATION COLLABORATIVE GROUP.- Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlied trial. Lancet, 2: 1323-1327, 1983.
10. FRANCIS, D. P.; HADLER, S. C; THOMPSON, S. E.; MAYNARD, J. E.; OSTROW, D. G , ALTMAN, N.; BRAFF, E. H.; O'MALLEY, P.; HAWKINS, D.; JUDSON, F. N.; PENLEY, K ; NYLUND, T.; CHRISTIE, G.: MEYERS, F.; MOORE Jr., J. N.; GARDNER, A.; DOTO, I. L.; MILLER, J. H.; REYNOLDS, G. H.; MURPHY, B. L.; SCHABLE, C. A.; CLARK, B. T.; CURRAN, J. W. & REDEKER, A. G. - The prevention of hepatitis B with vaccine. Report of the Center for Disease Control Multi-Center. Efficacy trial among homosexual men. Ann. intern. Med., 79: 362-366, 1982.
11. GRAEFF, P. A.; DANKERT, J.; ZEEUW, D.; GIPS, C. M. & VAN DER HELM, G. K. - Immune response to two different hepatitis B vaccine in haemodialysis patients: a 2-year follow-up. Nephron, 40: 155-160, 1985.
12. INACTIVATED hepatitis B virus-vaccine. M. M. W. R., 31: 317-328, 1982.
13. JUNGERS, P.; DELAGNEAU, J. F.; PRUNET, P. & CROSNIER, J. - Vaccination against hepatitis B in hemodialysis centre. In: Advances of Nephrology Chicago, Year Book Medical Publishers, 1982. p. 303-327.
14. LAPLANCHE, A.; COUROUCÊ, A. M.; BENHAMOU, E.; JUNGERS, P. & CROSNIER, J. - Responses to hepatitis B vaccine. Lancet, 1: 222, 1982.
15. LELIE, P. N.; REESINK, H. W.; JONG VAN MANEN, S. T.; DEES, P. J. & REERINK-BRONGERS, E. E. - Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB). Studies in volunteers at a low risk of infection with hepatitis B virus. Amer. J. Epidem., 20: 694-702, 1984.
16. LONDON, W. T.; DREW, J. S.; LUSTBADER, E. D.; WERENER, B. G. & BLUMBERG, B. S. - Host response to hepatitis B infection in patients in a chronic hemodialysis units. Kidney Int., 12: 51-58, 1977.
17. MAUPAS, S. P.; CHIRON, J. P.; BARIN, F.; COURSAGET, P.; GOUDEAU, A.; PERRIN, J.; DENIS, F. & DIPMAR, Y. - Efficacy of hepatitis B vaccine in prevention of early HBsAg carrier state in children. Controlled trial in an endemic area. Lancet, 1: 289-292, 1981.
18. SZMUNESS, W.; STEVENS, C. E.; HARLEY, E. J.; ZANG, E. A.; OLESZKO, W. R.; WILLIAM, D. C.; SADOVSKY, R.; MORRISON, J. M. & KELLNER, A - Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United State. New Engl. J. Med., 303: 833-841, 1980.

Address for correspondence:

Clara Fumiko Tachibana Yoshida

Fundação Oswaldo Cruz

Departamento de Virologia

Av. Brasil, 4365

CEP 21040 Rio de Janeiro, RJ., Brasil

Publication Dates

Publication in this collection
17 Feb 2011
Date of issue
Feb 1988

History

Received
18 Aug 1987

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

[1] 1. BENHAMOU, E., COUROUCÊ, A. M.; JUNGERS, D.; LAPLANCHE, A.; DEGOS, F.; BRANGIER, J. & CROSNIER, J. - Hepatitis B vaccine: randomized trial of immunogenicity in hemodialysis patients. Clin. Nephrol., 21: 143-147, 1984.

[2] 2. BRUMMELHUIS, H. G. J.; WILSON-DE-STURLER, L. A. & KAAP, A. K. - Preparation of hepatitis B vaccine by heat inactivation. In: MAUPAS, P. & GUESRY, P., ed. Hepatitis vaccine Amsterdam, Elsevier/North-Holland Biomedical Press, 1981. p. 51 56. (INSERM Simposium nş 18).

[3] 3. CAMARGO, I. F.; GASPAR, A. M. C. & YOSHIDA, C. F. T. - Comparative ELISA reagents for detection of hepatitis B surface antigen (HBsAg). Mem. Inst. Oswaldo Cruz, 82: 181-187, 1987.

[4] 4. COUROUCÉ, A. M.; JUNGERS, P.; BENHAMOU, E.; LAPLANCHE, A. & CROSNIER, J. - Hepatitis B vaccine in dialysis patients. New Engl. J. Med., 311: 1515-1516, 1984.

[5] 5. COUTINHO, R. A.; LELIE, P. N. & ALBRECHT VAN LENT, P. - The efficacy of a heat inactivated hepatitis B vaccine in male homosexuals; outcome of a placebo controlled double blind trial. Brit. med. J., 286: 1305-1308, 1983.

[6] 6. CROSNIER, J.; JUNGERS, P.; COUROUCÊ, A. M.; LAPLANCHE, A.; BENHAMOU, E.; DEGOS, F.; LACOUR, B ; PRUNET, P.; CERISIER, Y. & GUESRY, P. - Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in French haemodialysis units. I. Medical Staff. Lancet, 1: 455-459, 1981.

[7] 7. CROSNIER, J.; JUNGERS, P ; COUROUCÊ, A. M.; LAPLANCHE, A.; BENHAMOU, E.; DEGOS, F.; LACOUR, B.; PRUNET, P.; CERISIER, Y. & GUESRY, P. - Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in French haemodialysis units. II. Hemodialysis patients. Lancet, 1: 797-800, 1981.

[8] 8. DESMYTER, J.; COLAERJ, J.; GROOTE, G REYNDERS, M. & REERINK-BRONGERS, E. E. - Efficacy of heat inactivated hepatitis B vaccine in haemodialysis patients and staff: double blind, placebo controled trial. Lancet, 2: 1323-1327, 1983.

[9] 9. DESMYTER, J.; COLAERT, J.; GROOTE, G.; REYNDERS, M.; REERINK-BRONGERS, E. E.; LELIE, P. N.; DEES, P. J.; REESINK, H. W. & LEUVEN RENAL TRANSPLANTATION COLLABORATIVE GROUP.- Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlied trial. Lancet, 2: 1323-1327, 1983.

[10] 10. FRANCIS, D. P.; HADLER, S. C; THOMPSON, S. E.; MAYNARD, J. E.; OSTROW, D. G , ALTMAN, N.; BRAFF, E. H.; O'MALLEY, P.; HAWKINS, D.; JUDSON, F. N.; PENLEY, K ; NYLUND, T.; CHRISTIE, G.: MEYERS, F.; MOORE Jr., J. N.; GARDNER, A.; DOTO, I. L.; MILLER, J. H.; REYNOLDS, G. H.; MURPHY, B. L.; SCHABLE, C. A.; CLARK, B. T.; CURRAN, J. W. & REDEKER, A. G. - The prevention of hepatitis B with vaccine. Report of the Center for Disease Control Multi-Center. Efficacy trial among homosexual men. Ann. intern. Med., 79: 362-366, 1982.

[11] 11. GRAEFF, P. A.; DANKERT, J.; ZEEUW, D.; GIPS, C. M. & VAN DER HELM, G. K. - Immune response to two different hepatitis B vaccine in haemodialysis patients: a 2-year follow-up. Nephron, 40: 155-160, 1985.

[12] 12. INACTIVATED hepatitis B virus-vaccine. M. M. W. R., 31: 317-328, 1982.

[13] 13. JUNGERS, P.; DELAGNEAU, J. F.; PRUNET, P. & CROSNIER, J. - Vaccination against hepatitis B in hemodialysis centre. In: Advances of Nephrology Chicago, Year Book Medical Publishers, 1982. p. 303-327.

[14] 14. LAPLANCHE, A.; COUROUCÊ, A. M.; BENHAMOU, E.; JUNGERS, P. & CROSNIER, J. - Responses to hepatitis B vaccine. Lancet, 1: 222, 1982.

[15] 15. LELIE, P. N.; REESINK, H. W.; JONG VAN MANEN, S. T.; DEES, P. J. & REERINK-BRONGERS, E. E. - Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB). Studies in volunteers at a low risk of infection with hepatitis B virus. Amer. J. Epidem., 20: 694-702, 1984.

[16] 16. LONDON, W. T.; DREW, J. S.; LUSTBADER, E. D.; WERENER, B. G. & BLUMBERG, B. S. - Host response to hepatitis B infection in patients in a chronic hemodialysis units. Kidney Int., 12: 51-58, 1977.

[17] 17. MAUPAS, S. P.; CHIRON, J. P.; BARIN, F.; COURSAGET, P.; GOUDEAU, A.; PERRIN, J.; DENIS, F. & DIPMAR, Y. - Efficacy of hepatitis B vaccine in prevention of early HBsAg carrier state in children. Controlled trial in an endemic area. Lancet, 1: 289-292, 1981.

[18] 18. SZMUNESS, W.; STEVENS, C. E.; HARLEY, E. J.; ZANG, E. A.; OLESZKO, W. R.; WILLIAM, D. C.; SADOVSKY, R.; MORRISON, J. M. & KELLNER, A - Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United State. New Engl. J. Med., 303: 833-841, 1980.