[Immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine (YDV) on adults].
OBJECTIVE
To study the immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine (YDV) on adults.


METHODS
One hundred twenty-four healthy teachers of 22 - 58 years old, were randomly selected in Beipiao city, Liaoning province. Their HBsAg, anti-HBs and anti-HBc were all negative and temperature was normal. They were vaccinated with 5 microgram/0.5 ml of YDV, which was made in Beijing Institute of Biologic Products, at 0, 1, 6 months.


RESULTS
The positive rates of anti-HBs were 35.0%, 83.3%, 67.2% (P < 0.01) with the mean geometric titre (GMT) of anti-HBs 12.63 mIU/ml, 402.04 mIU/ml and 70.28 mIU/ml (P < 0.01) at 3th, 7th, 12th months respectively. The positive rates of anti-HBs and GMT of anti-HBs became the highest at 7th month, then began to decrease sharply. At 3th, 7th, 12th months the positive rates of anti-HBs and GMT of anti-HBs were higher on female compared to male, but only GMT of anti-HBs was significantly different at 3th month; the positive rates of anti-HBs in below 35 years old group was higher than 35 and over years old group, but it was significantly different only at 12th month. GMT of anti-HBs between the two groups was no obvious difference. Local or systematic addictive reactions were not found in all the subjects in 3 days after injection.


CONCLUSIONS
YDV is effective and safety to adults. The duration of anti-HBs should be further observed.
Shi
J
J
First Clinical College, China Medical University, Shenyang 110001, China.
Li
Z
Z
Zheng
L
L
D000328:Adult; D000367:Age Factors; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*; D015003:Yeasts / Q000235:genetics
D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic