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Four-year experience with a recombinant hepatitis B vaccine

Vier Jahre Erfahrung mit einem rekombinanten Impfstoff gegen Hepatitis B

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Summary

Three hundred and forty-three healthy adults were vaccinated with five different lots of recombinant hepatitis B vaccine. Three hundred and forty (99.1%) individuals produced antibodies against hepatitis B surface antigen (anti-HBs). Peak anti-HBs concentrations were significantly higher in females and younger individuals. All anti-HBs positive individuals developed antibodies to the common determinant “a” of HBsAg. The vaccine was well tolerated, without severe side reactions. Persistence of anti-HBs was followed in 130 individuals for 3, and in 15 for 4 years after the first vaccination of these two groups. 21.7% and 32.3%, respectively, no longer had protective levels of anti-HBs after this time. The persistence of anti-HBs was dependent on peak anti-HBs levels, with consistent kinetics of anti-HBs decline. Revaccination of individuals whose specific antibody levels had fallen below 10 IU/l led to a prompt anti-HBs response. Comparison with individuals vaccinated with plasma-derived hepatitis B vaccine revealed no substantial differences between the two vaccines.

Zusammenfassung

343 gesunde Erwachsene wurden mit fünf verschiedenen Chargen einer rekombinanten Hepatitis-B-Vakzine geimpft. 340 (99,1%) Impflinge bildeten Antikörper gegen Hepatitis B Oberflächenantigen (anti-HBs). Frauen und jüngere Personen wiesen höhere Anti-HBs-Werte auf. Alle Anti-HBs-positiven Personen entwickelten Antikörper gegen die allen Hepatitis-B-Virus-Subtypen gemeinsame Determinante „a“. Die Verträglichkeit des Impfstoffs war sehr gut, schwerere Nebenwirkungen wurden nicht beobachtet. Die Persistenz von Anti-HBs konnte bei 130 Personen drei Jahre und bei 15 Personen vier Jahre lang nach der ersten Impfung verfolgt werden. 21,7% bzw. 32,3% der Impflinge hatten nach dieser Zeit keine schützenden Anti-HBs-Titer mehr. Die Persistenz von Anti-HBs erwies sich als deutlich abhängig von der maximalen Anti-HBs-Konzentration, wobei die Kinetik, mit der Anti-HBs absank, relativ konstant war. Wiederimpfung von Personen, deren Anti-HBs-Spiegel auf Werte von 10 IU/l oder darunter abgesunken waren, führte zu einer sofortigen Immunantwort. Ein Vergleich dieser Befunde mit den Ergebnissen, die mit dem aus Plasma hergestellten Impfstoff erzielt wurden, zeigte keine größeren Unterschiede zwischen beiden Impfstoffen.

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  1. Max von Pettenkofer Institute for Hygiene and Medical Microbiology, University of Munich, Pettenkoferstraße 9a, D-8000, Munich 2

    W. Jilg,  Marion Schmidt &  F. Deinhardt

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  1. W. Jilg
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  2. Marion Schmidt
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  3. F. Deinhardt
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Jilg, W., Schmidt, M. & Deinhardt, F. Four-year experience with a recombinant hepatitis B vaccine. Infection 17, 70–76 (1989). https://doi.org/10.1007/BF01646879

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  • DOI: https://doi.org/10.1007/BF01646879

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