Summary of clinical findings on Engerix-B, a genetically engineered yeast derived hepatitis B vaccine.
Between February 1984 and August 1986 results have been obtained in 58 completed or ongoing clinical studies by 33 investigators in 19 countries on a yeast-derived recombinant DNA hepatitis B vaccine (Engerix-B). Among the 6100 subjects enrolled in these studies, 5664 subjects (150 normal neonates, 178 neonates of hepatitis B carrier mothers, 330 children aged 3-10 years, 3697 young healthy adults, 438 homosexual males, 110 older healthy adults, 139 drug addicts, 262 institutionalized mentally retarded patients, 59 thalassaemics, 25 sicklaemics, 270 patients on chronic haemodialysis and 6 haemophiliacs) received one or more (up to 4) injections of different doses of the yeast-derived vaccine according to either a 0, 1, 2, and 12 month or a 0, 1, and 6 month vaccination schedule. In randomized comparative studies 436 subjects received either one of two commercially available plasma-derived vaccines. The results reviewed in the present summary have shown that Engerix-B is safe, clinically well tolerated, gives an anti-HBs response which is qualitatively and quantitatively similar to that obtained with plasma-derived vaccines and confers protection against infection and disease. Engerix-B can be considered as a valid alternative to existing hepatitis B vaccines.
André
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SmithKline Biologicals, Rixensart, Belgium.
Safary
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D000328:Adult; D000941:Antigens / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant / Q000276:immunology; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D012441:Saccharomyces cerevisiae / Q000235:genetics; D014611:Vaccination / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000941:Antigens; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D014614:Vaccines, Synthetic