Recombinant hepatitis B vaccine is mainly divided into yeast, (Saccharomyces cerevisiae and methylotrophic yeast) and China hamster ovary (CHO) expression vaccine. Saccharomyces cerevisiae (Saccharomyces cerevisiae)
Valenzuela successfully expressed HBsAg in Saccharomyces cerevisiae for the first time in 1982. 1September, 1986, Merck heavy yeast hepatitis B vaccine was patented for the first time and approved by FDA. 1In July, 1989, another recombinant yeast hepatitis B vaccine from Scobicheng Company in Belgium was also patented. In addition to Merck and SmithKline, Beijing Tiantan Bio and Shenzhen Kangtai Company, the producers of recombinant yeast hepatitis B vaccine, also produce this vaccine in large quantities. Its advantages are: yeast is a lower eukaryotic microorganism, easy to ferment and cultivate in a medium with simple nutrients, industrialized production and high expression. Most vaccines produced and marketed on a large scale in the world are prepared by this expression system. Newborns:
(1) Protection rate of mother-to-child transmission interruption: Six batches of domestic 5 μg yeast vaccine were used to evaluate the effect of mother-to-child transmission interruption on 163 newborns with HbsAg and HbeAg positive mothers. The results show that the protection rate is between 8 1.48-92.07%. It is much higher than the reported 10 μg(59.2%) and 20 μg(74.3%) blood-borne hepatitis B vaccine, and the protection rate is equivalent to 30 μg blood-borne hepatitis B vaccine (85. 1%), while imported 5 μg M vaccine (46 cases) and 10 μg vaccine. The results showed that the immune effect of domestic yeast vaccine reached the protection level of similar foreign products and 30 μg domestic blood-borne hepatitis B vaccine.
(2) Antibody GMT: There was no significant difference in antibody GMT between newborns born to HbsAg and HbeAg-positive pregnant women and newborns born to HBsAg-positive pregnant women and healthy pregnant women at 3, 9 and 12 months after the first vaccination.
Student:
(1) antibody positive rate: After the first vaccination 1 year, there was no significant difference in antibody positive rate among imported zymogen vaccine, domestic yeast vaccine and domestic CHO vaccine at 3, 9 and 12 months after the first vaccination.
(2) Comparison of antibody CMT: One year after the first inoculation, the GMT peak of antibody of imported yeast vaccine (10 μg) and domestic CHO vaccine (10 μg) was higher, while the GMT peak of antibody of domestic yeast vaccine (5 μg) was lower. Follow-up observation was carried out on primary school students immunized at 0,/kloc-0 and 6 months. During the one-year and three-year follow-up, the positive conversion rates of protective antibodies (10mIU/ml) of two batches of domestic yeast vaccines were 8 1.48% respectively. 68.66% and 92.11%; 74. 14%, while imported vaccines A and M were 90.38% respectively. 69.56% and 93.10%; 78.05%。 The antibody GMT of two batches of domestic yeast vaccines is 123.99, respectively. 146. 10 and 92.11; 83.52, A and M vaccines were120.56 respectively; 67.07 and145.75; 74.62。
400 pupils immunized at 0,/kloc-0 and 2 months were followed up for 4 years. Results The positive rates of three batches of domestic fermented vaccines were 87.50% respectively. 77.33%; 79.49%, while the control M(5 μg) vaccine was 9 1.89, and the antibody GMT was 65.57. 7 1.40; 59.20 and 74.84. From June to the peak of antibody in 4 years, the negative conversion rates of antibodies in three batches of domestic vaccines were 7.2 respectively; 5.26 and 13.79%, while the control seedlings were 5. 17%. There is no significant difference between the three batches of domestic vaccines and M vaccine in terms of antibody positive rate, antibody GMT and 4-year antibody negative conversion rate.
With this result, we found that the antibody positive rate of two batches of domestic yeast hepatitis B vaccine dropped below 70% five years after immunization, while the antibody positive rate of blood-borne hepatitis B vaccine was between 865,438+0-69% in the same period.
The results showed that the immune effect of domestic yeast recombinant hepatitis B vaccine reached the immune level of imported yeast vaccine, but the antibody positive rate and antibody GMT decreased rapidly. Considering the sufficient supply of hepatitis B vaccine at present, yeast vaccination should be put on the agenda.