Reactogenicity and immunogenicity of a recombinant hepatitis B vaccine compared with a plasma-derived vaccine in young adults. 1987

M Just, and R Berger, and V Just
University Children's Hospital, University of Basel, Switzerland.

A study of the immunogenicity and reactogenicity of three doses of lot L (10, 20, 40 micrograms), two doses of lot N (10, 20 micrograms) of the SmithKline Biologicals recombinant DNA yeast-derived hepatitis B vaccine and a 20 micrograms dose of the Merck, Sharp & Dohme plasma-derived hepatitis B vaccine was conducted in young adults under randomized, double-blind conditions. Immunization was carried out according to a 0, 1, and 6 month vaccination schedule. Results indicated that the yeast-derived hepatitis B vaccine was well tolerated and highly immunogenic. Reactogenicity to both yeast- and plasma-derived vaccines was mild in severity and low in incidence with no significant differences appearing between the study groups. One month after the third dose, the yeast-derived vaccines induced a high degree of seroconversion ranging between 97.8% and 100%. The response was not lot- or dose-dependent. The administration of the plasma-derived vaccine resulted in an anti-HBs geometric mean titre approximately twice as high as those elicited by the different yeast-derived hepatitis B vaccine doses one month after the third inoculation. However, 11 months following the third dose of vaccine, the anti-HBs titres were similar in all groups. Revaccination of subjects who no longer had detectable anti-HBs one year after the last vaccine dose resulted in an anamnestic response.

UI MeSH Term Description Entries
D008297 Male Males
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004274 DNA, Recombinant Biologically active DNA which has been formed by the in vitro joining of segments of DNA from different sources. It includes the recombination joint or edge of a heteroduplex region where two recombining DNA molecules are connected. Genes, Spliced,Recombinant DNA,Spliced Gene,Recombinant DNA Research,Recombination Joint,DNA Research, Recombinant,Gene, Spliced,Joint, Recombination,Research, Recombinant DNA,Spliced Genes
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006509 Hepatitis B INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. Hepatitis B Virus Infection
D006510 Hepatitis B Antibodies Antibodies to the HEPATITIS B ANTIGENS, including antibodies to the surface (Australia) and core of the Dane particle and those to the "e" antigens. Anti-Australia Antigens,Anti-HBAg,Anti-Hepatitis B Antigens,Anti HBAg,Hepatitis B Virus Antibodies,Anti Australia Antigens,Anti Hepatitis B Antigens,Antibodies, Hepatitis B,Antigens, Anti-Australia,Antigens, Anti-Hepatitis B,B Antibodies, Hepatitis,B Antigens, Anti-Hepatitis,HBAg, Anti
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000941 Antigens Substances that are recognized by the immune system and induce an immune reaction. Antigen

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