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Yeast recombinant hepatitis B vaccine

Rekombinante Hepatitis B-Vakzine aus Hefe

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Summary

Human hepatitis B virus vaccine was prepared using antigen produced by recombinant technology in yeast (Saccharomyces cerevisiae). The highly purified antigen had the correct amino acid sequence and assumed the appropriate conformational structure to present the immunologic determinants (epitopes) that are needed to stimulate an appropriate immune response. Yeast-derived vaccine, was safe and was equally immunogenic and protective against hepatitis B as plasma-derived vaccine, as demonstrated in tests carried out in animals and in human beings. The yeast-derived vaccine produced by the Merck Sharp & Dohme Research Laboratories was licensed for general use in the Federal Republic of Germany in May and in the United States of America on July 23, 1986. It represents the first licensed vaccine of any kind produced by recombinant technology, and establishes the precedent for new vaccines to be made using this methodology.

Zusammenfassung

Zur Herstellung einer humanen Hepatitis B Virus-Vakzine wurde Antigen verwendet, das mittels rekombinanter Technologien aus Hefe (Saccharomyces cerevisiae) gewonnen wurde. Das hochgereinigte Antigen besitzt die exakt richtige Aminosäuresequenz und nimmt eine für die Präsentation der immunogenen Determinanten (Epitope) erforderlichen Tertiärstruktur ein und erfüllt somit die Voraussetzungen für die Auslösung einer entsprechenden Immunantwort. Untersuchungen in Tieren und beim Menschen zeigten, daß die aus Hefe gewonnene Vakzine sicher ist und eine der aus Plasma hergestellten Vakzine vergleichbare immunogene und protektive Wirkung hat. Die in den Forschungslaboratorien von Merck Sharp & Dohme mittels Hefezellen entwickelte Vakzine wurde im Mai 1986 in der Bundesrepublik und am 23. Juli dieses Jahres in den Vereinigten Staaten von Amerika zugelassen. Sie ist die erste mittels rekombinanter Technologien gewonnene, lizensierte Vakzine überhaupt und ist der Wegbereiter für neue mit dieser Methode entwickelte Impfstoffe.

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Authors and Affiliations

  1. Merck Sharp & Dohme Research Laboratories, Merck Institute for Therapeutic Research, 19486, West Point, Pennsylvania, USA

    M. R. Hilleman Ph.D.

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  1. M. R. Hilleman Ph.D.
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Additional information

This paper, in slightly different form, was presented at the Ninth International Congress of Infectious and Parasitic Diseases, Munich, West Germany, in Session V4, on July 24, 1986.

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Hilleman, M.R. Yeast recombinant hepatitis B vaccine. Infection 15, 3–7 (1987). https://doi.org/10.1007/BF01646107

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  • DOI: https://doi.org/10.1007/BF01646107

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