Safety and immunogenicity of hepatitis B vaccine ButaNG in adults

Author:

IOSHIMOTO Luzia M.1,RISSATO Maria Lúcia2,BONILHA Valentina S.J.2,MIYAKI Cosue1,RAW Isaias3,GRANOVSKI Nikolai4

Affiliation:

1. Instituto Butantan, Brazil

2. Fundação Amaral Carvalho, Brazil

3. Fundação Butantan, Brazil

4. N.G.Biotecnologia Ltd, Brazil

Abstract

Recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan was administered in two groups of adult volunteers (I, II) following two different schedules of immunization. In the first trial (10 <FONT FACE="Symbol">m</FONT>g doses and 0, 1, 3 months vaccination schedule) 106 individuals completed the full immunization program. The results of seroconversion by age group varied from 70 to 100% and the GMT from 46.5 to 124.9 mIU mL-1. In the second trial with 68 individuals (for dosage comparison and 0, 1, 6 months vaccination schedule) indicated that the vaccine formulated in 20 <FONT FACE="Symbol">m</FONT>g was more effective than in 10 <FONT FACE="Symbol">m</FONT>g. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.

Publisher

FapUNIFESP (SciELO)

Subject

Infectious Diseases,General Medicine

Reference13 articles.

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2. Immunogenicity of yeast-derived hepatitis B vaccines in young adults;BERGAMINI F.;Postgrad. med. J.,1987

3. Hepatites;CARRILHO F.J.,1986

4. Age and sex related study of hepatitis B virus chronic carrier area in infants from an endemic area;COURSAGET P.;J. med. Virol.,1987

5. Comparative multicentre study of the immunogenicity of different hepatitis B vaccines in healthy volunteers;GOUDEAU A.;Postgrad. med. J.,1987

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