Immunization aganist hepatitis B in children from endemic zone: evaluation of the antibody response against the DNA recombinant vaccine (Engerix B-20 mcg)

Ferreira, C.R.B.; Yoshida, C.F.T.; Mercadante, L.A.C.; Gomes, D.F.; Oliveira, J.M.; França, M.S.; Sidoni, M.; Ennes, I.C.; Baptista, M.L.; Schatzmayr, H.G.; Gaspar, A.M.C.

doi:10.1590/S0036-46651993000100013

Abstracts

A previous seroepidemiological study in the rural zone of Vargem Alta (ES) SouthEast of Brazil, showed a prevalence of up to 9% of hepatitis B surface antigen (HBsAg) in some areas. One hundred susceptible children aging 1 to 5 years old were selected and immunized with a recombinant DNA hepatitis B vaccine (Smith-Kline 20 mcg) using the 0-1-6 months vaccination schedule. Blood samples were collected at the time of the first vaccine dose (month 0) in order to confirm susceptible individuals and 1,3,6 and 8 months after the first dose , to evaluate the antibody response. Our results showed that two and five months after the second dose, 79% and 88% of children seroconverted respectively, reaching 97% after the third dose. The levels of anti-HBs were calculated in milli International Units/ml (mIU/ml) and demonstrated the markedly increase of protective levels of antibodies after the third dose. These data showed a good immunogenicity of the DNA recombinant hepatitis B vaccine when administered in children of endemic areas.

DNA recombinant vaccine; Immune response-children; hepatitis B recombinant vaccine; Anti-HBs

Um estudo soroepidemiológico prévio na zona rural de Vargem Alta (ES) - Sudeste do Brasil, mostrou uma predominância de até 9% do antígeno de superfície da Hepatite B (HBsAg). Foram selecionadas 100 crianças com faixa etária entre 1 e 5 anos de idade, as quais foram imunizadas com vacina contra Hepatite B -DNA recombinante (Smith-Kline,20 mcg) nos meses 0,1 e 6. Foram coletadas amostras de sangue antes da primeira dose da vacina (mês 0) para confirmação dos susceptíveis, e nos meses 1,3,6 e 8 após a vacinação para avaliação da resposta vacinai. Os resultados mostraram que 79 e 88% das crianças apresentaram soroconversão dois e cinco meses após a segunda dose respectivamente, atingindo 97% de soroconversão, após a 3a.dose. Os níveis de anti-HBs foram calculados em miliunidades internacionais/ml (mUI/ml), demonstrando um considerável aumento dos níveis de anticorpos protetores após a 3a. dose. Os resultados demonstraram uma boa imunogenicidade da vacina de DNA recombinante contra hepatite B, quando administradas em crianças de áreas endêmicas.

SEROLOGY

Immunization aganist hepatitis B in children from endemic zone: evaluation of the antibody response against the DNA recombinant vaccine (Engerix B-20 mcg)

Imunização contra Hepatite B em crianças de zona endêmica: avaliação da resposta de anticorpo à vacina HB recombinante (Engerix B-20mcg)

C.R.B. Ferreira^I; C.F.T. Yoshida^I; L.A.C. Mercadante^I; D.F. Gomes^II; J.M. Oliveira^I; M.S. França^I; M. Sidoni^III; I.C. Ennes^III; M.L. Baptista^I; H.G. Schatzmayr^I; A.M.C. Gaspar^I

^IDepartamento de Virologia, Instituto Oswaldo Cruz, Fiocruz Rio de Janeiro, Brazil

^IILaboratório COPILAB, C.Itapemirim, Espírito Santo, Brazil

^IIIDepartamento de Produção II, Bio-Manguinhos, Fiocruz, Rio de Janeiro, Brazil

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

SUMMARY

A previous seroepidemiological study in the rural zone of Vargem Alta (ES) SouthEast of Brazil, showed a prevalence of up to 9% of hepatitis B surface antigen (HBsAg) in some areas.

One hundred susceptible children aging 1 to 5 years old were selected and immunized with a recombinant DNA hepatitis B vaccine (Smith-Kline 20 mcg) using the 0-1-6 months vaccination schedule. Blood samples were collected at the time of the first vaccine dose (month 0) in order to confirm susceptible individuals and 1,3,6 and 8 months after the first dose , to evaluate the antibody response. Our results showed that two and five months after the second dose, 79% and 88% of children seroconverted respectively, reaching 97% after the third dose.

The levels of anti-HBs were calculated in milli International Units/ml (mIU/ml) and demonstrated the markedly increase of protective levels of antibodies after the third dose. These data showed a good immunogenicity of the DNA recombinant hepatitis B vaccine when administered in children of endemic areas.

Key words: DNA recombinant vaccine; Immune response-children; hepatitis B recombinant vaccine; Anti-HBs

RESUMO

Um estudo soroepidemiológico prévio na zona rural de Vargem Alta (ES) - Sudeste do Brasil, mostrou uma predominância de até 9% do antígeno de superfície da Hepatite B (HBsAg). Foram selecionadas 100 crianças com faixa etária entre 1 e 5 anos de idade, as quais foram imunizadas com vacina contra Hepatite B -DNA recombinante (Smith-Kline,20 mcg) nos meses 0,1 e 6. Foram coletadas amostras de sangue antes da primeira dose da vacina (mês 0) para confirmação dos susceptíveis, e nos meses 1,3,6 e 8 após a vacinação para avaliação da resposta vacinai. Os resultados mostraram que 79 e 88% das crianças apresentaram soroconversão dois e cinco meses após a segunda dose respectivamente, atingindo 97% de soroconversão, após a 3a.dose.

Os níveis de anti-HBs foram calculados em miliunidades internacionais/ml (mUI/ml), demonstrando um considerável aumento dos níveis de anticorpos protetores após a 3a. dose. Os resultados demonstraram uma boa imunogenicidade da vacina de DNA recombinante contra hepatite B, quando administradas em crianças de áreas endêmicas.

Full text available only in PDF format.

Texto completo disponível apenas em PDF.

ACKNOWLEDGEMENT

The authors are grateful to Salesian School of Jaciguá, the Secretary of Health of Espírito Santo, Padre Olívio Hospital and the Municipality of Vargem Alta for collaborating in sample collection and vaccination of the children. We also acknowledge Caroline Rouzeré for English text revision.

C.R.B. Ferreira was a training in our Department receiving support by CNPq fellowship (no.822054/89-2).

Recebido para publicação em 7/5/1992

Aceito para publicação em 4/9/1992

1. ANDRÉ, F.E. - Summary of safety and efficacy data on a Yeast-Derived Hepatitis B vaccine. Amer. J. Med., 87 (suppl3A): 14s-20s, 1989.
2. 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, 1987a.
3. CAMARGO, I.F.; COELHO, M.B.S.; MERCADANTE, L.A.C.; GASPAR, A.M.C. & YOSHIDA, C.R.T. - A direct "sandwich" ELISA for anti-HBs determination: comparison with indirect ELISA and RIA. Hepatitis Scientific Memoranda, Memo. H-2309: 1-3, 1987b.
4. CASTRO, E.J. & ROSA Fo., S.M. - Prophylaxis of Hepatitis B- Vaccine use of 2nd generation, recombinant-DNA. Acta hepat., 1: 24, 1991.
5. DAVIDSON, M. & KRUGMAN, S. - Recombinant Yeast Hepatitis B vaccine compared with plasma derived vaccine: immunogenicity and effect of a booster dose. J. Infect, 13 (suppl.A): 31-38, 1986.
6. FONSECA, J.C.F.; CASTEJON, M.J.; CESARIO, A.L.O.; BARONE, M. & BRASIL, L.M. - Immunogenicity of a recombinant DNA hepatitis B vaccine in children living in the Amazon Basin, Brazil. In: INTERNATIONAL SYMPOSIUM ON VIRAL HEPATITIS AND LIVER DISEASE. Scientific Program and Abstract Volume. Houston, Texas. 1990. p.110.
7. HILLEMAN, M.R.; WEIBEL, R.E. & SCOLNICK, E.M. - Recombinant yeast human hepatitis B vaccine. J. Hong Kong med. Ass., 37: 75-85, 1985.
8. ISAHAK, I.; MALIK, Y.A.; HAKIM, A.S. & BAHARIN, R. - The evaluation of Engerix B in healthy Malaysian Medical Students. Singapore med. J., 31: 314-316, 1990.
9. PANDA, S.K.; RAMESH, R.; RAO, K.V.S.; GUPTA, A.; ZUCKERMAN, A.I. & NAYAK, N.C. - Comparative evaluation of the immunogenicity of yeast-derived (recombinant) and plasma-derived hepatitis B vaccine in infants. J. med. Virol., 35: 297-302, 1991.
10. PAPAEVANGELOU, G.; KARAYANNIS, A.R.; VISSOULIS, C.; RICHARDSON, S.C. & KRUGMAN, S. - Immunogenicity of a five microgram dose of hepatitis B vaccine. J. med. Virol., 15: 65-69, 1985.
11. PĘTRE, I.; WIJNENDAELE, F.; DE NEYS, B.; CONRATH, K.; VAN OPSTAL, O.; HAUSER, P.; RUTGERS, T.; CABEZON, T.; CAPIAU, C.; HARFORD, N.; DE WILDE, M.; STEPHENNE, J.; CARR, S.; HEMLING, H. & SWADESH, I. - Development of a hepatitis B vaccine from transformed yeast cells. Postgrad. med. J., 63 (suppl.2): 73-81, 1987.
¹²
WORLD HEALTH ORGANIZATION - Prevention of liver cancer. 1983 (Technical Report Series no.691).
13. YOSHIDA, C.F.T.; TAKAHASHI, C,; MERCADANTE, L.A.C; BANDEIRA, M.F.S. & GASPAR, A.M.C. - Resposta imune ŕ vacina da Hepatite B (Hevac B, França) em unidade de diálise. J. bras. Nefrol., 2(1): 21-25, 1989.

Address for correspondence:

Clara Fumiko Tachibana Yoshida

Departamento de Virologia, Instituto Oswaldo Cruz, Fiocruz

Av.Brasil,4365

Cep 21040 Rio de Janeiro, RJ, Brazil

Publication Dates

Publication in this collection
11 Sept 2006
Date of issue
Feb 1993

History

Received
07 May 1992
Accepted
04 Sept 1992

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

[1] 1. ANDRÉ, F.E. - Summary of safety and efficacy data on a Yeast-Derived Hepatitis B vaccine. Amer. J. Med., 87 (suppl3A): 14s-20s, 1989.

[2] 2. 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, 1987a.

[3] 3. CAMARGO, I.F.; COELHO, M.B.S.; MERCADANTE, L.A.C.; GASPAR, A.M.C. & YOSHIDA, C.R.T. - A direct "sandwich" ELISA for anti-HBs determination: comparison with indirect ELISA and RIA. Hepatitis Scientific Memoranda, Memo. H-2309: 1-3, 1987b.

[4] 4. CASTRO, E.J. & ROSA Fo., S.M. - Prophylaxis of Hepatitis B- Vaccine use of 2nd generation, recombinant-DNA. Acta hepat., 1: 24, 1991.

[5] 5. DAVIDSON, M. & KRUGMAN, S. - Recombinant Yeast Hepatitis B vaccine compared with plasma derived vaccine: immunogenicity and effect of a booster dose. J. Infect, 13 (suppl.A): 31-38, 1986.

[6] 6. FONSECA, J.C.F.; CASTEJON, M.J.; CESARIO, A.L.O.; BARONE, M. & BRASIL, L.M. - Immunogenicity of a recombinant DNA hepatitis B vaccine in children living in the Amazon Basin, Brazil. In: INTERNATIONAL SYMPOSIUM ON VIRAL HEPATITIS AND LIVER DISEASE. Scientific Program and Abstract Volume. Houston, Texas. 1990. p.110.

[7] 7. HILLEMAN, M.R.; WEIBEL, R.E. & SCOLNICK, E.M. - Recombinant yeast human hepatitis B vaccine. J. Hong Kong med. Ass., 37: 75-85, 1985.

[8] 8. ISAHAK, I.; MALIK, Y.A.; HAKIM, A.S. & BAHARIN, R. - The evaluation of Engerix B in healthy Malaysian Medical Students. Singapore med. J., 31: 314-316, 1990.

[9] 9. PANDA, S.K.; RAMESH, R.; RAO, K.V.S.; GUPTA, A.; ZUCKERMAN, A.I. & NAYAK, N.C. - Comparative evaluation of the immunogenicity of yeast-derived (recombinant) and plasma-derived hepatitis B vaccine in infants. J. med. Virol., 35: 297-302, 1991.

[10] 10. PAPAEVANGELOU, G.; KARAYANNIS, A.R.; VISSOULIS, C.; RICHARDSON, S.C. & KRUGMAN, S. - Immunogenicity of a five microgram dose of hepatitis B vaccine. J. med. Virol., 15: 65-69, 1985.

[11] 11. PĘTRE, I.; WIJNENDAELE, F.; DE NEYS, B.; CONRATH, K.; VAN OPSTAL, O.; HAUSER, P.; RUTGERS, T.; CABEZON, T.; CAPIAU, C.; HARFORD, N.; DE WILDE, M.; STEPHENNE, J.; CARR, S.; HEMLING, H. & SWADESH, I. - Development of a hepatitis B vaccine from transformed yeast cells. Postgrad. med. J., 63 (suppl.2): 73-81, 1987.

[12] ¹²
WORLD HEALTH ORGANIZATION - Prevention of liver cancer. 1983 (Technical Report Series no.691).

[13] 13. YOSHIDA, C.F.T.; TAKAHASHI, C,; MERCADANTE, L.A.C; BANDEIRA, M.F.S. & GASPAR, A.M.C. - Resposta imune ŕ vacina da Hepatite B (Hevac B, França) em unidade de diálise. J. bras. Nefrol., 2(1): 21-25, 1989.