Abstract
A recombinant yeast-derived pre-S2 + S-containing hepatitis B vaccine (TGP-943) was clinically evaluated through three phases of testing in a total of 2137 volunteers. We observed the immunogenic purity of TGP-943 (phase 1), the inter-lot reproducibility of both safety and immunogenicity (phase 2), no significant side-effects, a high capability of inducing both anti-HBs and anti-pre-S2 antibodies (phases 1, 2 and 3), and an ability to induce seroconversion in the majority of vaccines who had been non-responsive to conventional hepatitis B vaccines (phases 2 and 3). In conclusion, TGP-943 is a safe and tolerable vaccine, with special merits: the ability to induce an early anti-pre-S2 response that circumvents the problem of delayed appearance of anti-HBs, and efficacy in non-responders to previous vaccination.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Clinical Trial, Phase III
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Adolescent
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Adult
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Age Factors
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Amino Acid Sequence
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Child
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Female
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Hepatitis B Antibodies / biosynthesis
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Hepatitis B Surface Antigens / immunology*
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Hepatitis B Vaccines / administration & dosage
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Hepatitis B Vaccines / adverse effects
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Hepatitis B Vaccines / immunology*
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Humans
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Injections, Intramuscular
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Injections, Subcutaneous
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Male
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Middle Aged
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Molecular Sequence Data
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Protein Precursors / immunology*
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Radioimmunoassay
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Reproducibility of Results
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Safety
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Vaccines, Synthetic / administration & dosage
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Vaccines, Synthetic / adverse effects
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Vaccines, Synthetic / immunology
Substances
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Hepatitis B Antibodies
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Hepatitis B Surface Antigens
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Hepatitis B Vaccines
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Protein Precursors
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TGP 943 vaccine
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Vaccines, Synthetic