Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

Memorias do Instituto Oswaldo Cruz

Volumn 99, Issue 8, 2004, Pages 865-871

  Martins, Reinaldo Menezes ^a   Bensabath, Gilberta ^b   Arraes, Luiz Claudio ^c   Oliveira, Maria De Lourdes Aguiar ^d   Miguel, Juliana Custódio ^d   Barbosa, Glayse Glayde ^e   Camacho, Luiz Antonio Bastos ^d  

^a MINISTÉRIO DA SAÚDE   (Brazil)

^b INSTITUTO EVANDRO CHAGAS   (Brazil)

^c INSTITUTO DE MEDICINA INTEGRAL PROF FERNANDO FIGUEIRA   (Brazil)

^d INSTITUTO OSWALDO CRUZ   (Brazil)

^e Lar de Frei Luiz   (Brazil)

Author keywords

Hepatitis B vaccine; Immunization; Recombinant vaccines

Indexed keywords

BUTANG; HEPATITIS B ANTIBODY; RECOMBINANT HEPATITIS B VACCINE;

ADOLESCENT; ADULT; AGE DISTRIBUTION; ANTIBODY TITER; ARTICLE; BRAZIL; CHILD; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FEMALE; GEOMETRY; HEPATITIS B; HUMAN; IMMUNOGENICITY; INFANT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEWBORN; PROSPECTIVE STUDY; PRURITUS; URTICARIA;

EID: 13844266534     PISSN: 00740276     EISSN: None     Source Type: Journal    
DOI: 10.1590/S0074-02762004000800014     Document Type: Article

References (23)

1. Adkins JC, Wagstaff AJ 1998. Recombinant hepatitis B vaccine. A review of its immunogenicity and protective efficacy against hepatitis B. Biodrugs 10: 137-158.
2. André FE 1989. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 87 (Suppl. 3A): 14S-20S.
3. Assad S, Francis A 1999. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine 18: 51-61.
4. Baldy JLS, Lima GZ, Morimoto HK, Reiche EMV, Matsuo T, Mattos ED, Pulga LC 2004. Immunogenicity of three recombinant hepatitis B vaccines administered to students in three doses containing half the antigen amount routinely used for adult vaccination. Rev Inst Med Trop São Paulo 46: 103-107.
5. Blackwelder WC 1998. Equivalence trials. In P Armitage, T Colton (eds), Encyclopedia of Statistics, vol. 1, Wiley & Sons, Chichester, p. 1367-72.
6. Bray GA 1989. Classification and evaluation of the obesities. Med Clin North Am 73: 161-84.
7. CDC 2004. Epidemiology Program Office. Epi-Info version 3.2.2.
8. Costa AA, Inenami M, Juarez E, Llacen PD, Raw I 1997. Preliminary report of the use on adults of a recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan. Rev Inst Med Trop São Paulo 39: 39-42.
9. Dean AG, Dean JA, Coulombier D, Burton AH, Brendel KA, Smith DC, Dicker RC, Sullivan KM, Fagan RF 1994. Epi Info, Version 6, CDC, Atlanta, GA.
10. Ferreira CRB, Yoshida CFT, Mercadante LAC et al. 1993. Immunization against hepatitis B in children from an endemic zone: evaluation of the antibody response against the DNA recombinant vaccine (Engerix B-20mcg). Rev Inst Med Trop São Paulo 35: 89-92.
11. Fisman DN, Agrawal D, Leder K 2002. The effect of age on immunologic response to recombinant hepatitis B vaccine: a meta-analysis. Clin Infect Dis 35: 1368-1375.
12. Gadelha C, Azevedo N 2003. Vaccine innovations in Brazil: recent experiences and structural constraints. In Immunization in Brazil - History and perspectives. História, Ciências, Saúde - Manguinhos 10 (Suppl. 2): 709-712.
13. Greenberg DP 1993. Pediatric experience with recombinant hepatitis B vaccines and relevant safety and immunogenicity studies. Pediatr Infect Dis J 12: 438-445.
14. Hieu NT, Kim KH, Janowicz Z, Timmermans I 2002. Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years. Vaccine 20: 1803-1808.
15. Ioshimoto LM, Rissato ML, Bonilha VSJ, Miyaki C, Raw I, Granovski N 1999. Safety and immunogenicity of hepatitis B vaccine Butang in adults. Rev Inst Med Trop São Paulo 41: 191-193.
16. Keating GM, Noble S 2003. Recombinant hepatitis B vaccine (Engerix B). A review of its immunogenicity and protective efficacy against hepatitis B. Drugs 63: 1021-1051.
17. Leroux-Roels G, Abraham B, Fourneau M, De Clercq N, Safary A 2000. A comparison of two commercial recombinant vaccines for hepatitis B in adolescents. Vaccine 19: 937-942.
18. Mahoney FJ, Kane M 1999. Hepatitis B vaccine. In SA Plotkin, EA Orenstein (eds), Vaccines, 3rd ed., Saunders, Philadelphia, p. 158-82.
19. Motta MSF, Mussi-Pinhata MM, Jorge SM, Yoshida CFT, Souza CBS 2002. Immunogenicity of hepatitis B vaccine in preterm and full term infants vaccinated within the first week of life. Vaccine 20: 1557-1562.
20. Saari TN 2003. Immunization of preterm and low birth weight infants. Pediatrics 112: 193-198.
21. Ul-Haq N, Hasnain SS, Umar M, Abbas Z, Valenzuela-Silva C, Lopez-Saura P 2003. Immunogenicity of 10 and 20 μg hepatitis B vaccine in a two-dose schedule. Vaccine 21: 3179-3185.
22. Vanlandschoot P, Van Houtte F, Hoek F, Nieuwland R, Leroux-Roels G 2003. Saccharomyces cerevisiae-derived HBsAg preparations differ in their attachment to monocytes, immune-suppressive potential, and T-cell immunogenicity. J Med Virol 70: 513-519.
23. WHO 2001. Hepatitis B potency testing standardization. Report of a Meeting, WHO/SEARO, New Delhi, 9-11 April.