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Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine ( CLB ) . Studies in volunteers at a low risk of infection with hepatitis B virus . The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine ( CLB ) were evaluated in 471 healthy human volunteers , who , both in their occupations and in their private lives , had been at minimal risk of being infected with hepatitis B virus . The first 202 individuals received three 3-micrograms doses of heat-inactivated hepatitis B surface antigen ( HBsAg ) at one-month intervals ( trial A ) . A total of 42 % one month after the first injection , 84 % after two months , and 93 % after five months had become anti-HBs ( antibody to hepatitis B surface antigen ) positive . In a second randomized study ( trial B ) , the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers . When the dose of HBsAg was diminished from 3 micrograms to 1.5 , 0.6 , and 0.25 microgram , no decrease of the anti-HBs response was observed . However , when the dose was diminished to 0.1 microgram of HBsAg , the anti-HBs response dropped significantly to 63 % ( p less than 0.001 ) . In the recipients of all five vaccine dosages , no influence of sex and age was found on the anti-HBs conversion rates . During the eight-month observation period , none of the vaccinees became HBsAg and/or anti-HBc ( antibody to hepatitis B core antigen ) positive , and none developed antibodies associated with autoimmune liver disease . No serious side effects were observed .
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Intervention_Pharmacological
plasma-derived heat-inactivated hepatitis B vaccine ( CLB )
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Intervention_Pharmacological
plasma-derived heat-inactivated hepatitis B vaccine ( CLB )
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Intervention_Pharmacological
three 3-micrograms doses of heat-inactivated hepatitis B surface antigen ( HBsAg ) at one-month intervals
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Intervention_Pharmacological
of five different dosages of the vaccine
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Outcome_Other
Immunogenicity
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Outcome_Other
safety
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Outcome_Other
safety
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Outcome_Other
immunogenicity
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Outcome_Other
immunogenicity
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Outcome_Physical
anti-HBs response
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Outcome_Physical
anti-HBs response
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Outcome_Physical
anti-HBs conversion rates .
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Outcome_Physical
HBsAg and/or anti-HBc ( antibody to hepatitis B core antigen ) positive
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Outcome_Physical
antibodies
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Outcome_Adverse-effects
serious side effects
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Participant_Condition
low risk of infection with hepatitis B virus
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Participant_Sample-size
471
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Participant_Condition
healthy
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Participant_Condition
hepatitis B virus