ABSTRACT
Objective To investigate the preparation of influenza virus vaccine without thimerosal for children dose and its sta-bility .Methods H1N1 ,H3N2 ,B-type influenza virus were inoculated into allantoic fluid to prepare three batches of influenza virus vaccine without thimerosal for children dose and the vaccine stability test was performed .Single radial immunodiffusion(SRID) and enzyme-linked immunosorbent assay(ELISA) were used to detect the concentration of hemagglutinin and egg albumin .Total protein concentration ,appearance ,sterility test ,endotoxin ,free formaldehyde and the pH value of vaccine were also measured .Results The pH value of vaccine was 7 .2 ,with total protein concentration of 182-189 mg/mL .Hemagglutinin concentrations of H1N1 ,H3N2 and B-type influenza virus decreased when they had been placed in 2-8 ℃ for 3 ,6 ,9 ,12 ,18 months or (37 .0 ± 2 .0) ℃ for 7 ,14 days ,however ,they maintained at 6 .0 μg/0 .25 mL or more at last .Conclusion Influenza virus vaccine without thimerosal for chil-dren dose shows improved safty and is accord with the standard of Chinese Pharmacopoeia(2010 edition) .
ABSTRACT
Due to the insufficient supply of embryonated chicken eggs,the preparation of large quantities of inactivated influenza vaccines will require an alternative virus culture system after the emergence or reemergence of a pandemic influenza virus.The Vero cell is one of the ideal options since it was used for producing many kinds of human vaccines.However,most of the influenza viruses can not grow well in Vero cells.To develop a new influenza vaccine with Vero cells as a substrate,the virus needs to adapt to this cell substrate to maintain high growth characteristics.By serial passages in Vero cells,the B/Yunnan/2/2005va(B)strain was successfully adapted to Vero cells,with the hemagglutination titer(HAT)of the virus reaching 1:512.The high growth characteristic of this strain is stable up to 21 passages.The strain was identified by hemagglutination inhibition (HAI)test and sequencing respectively;the HA;gene sequence of the virus was cloned and analyzed.The screening and establishment of high growth B virus provides an important tool for influenza vaccine production in Vero cells.
ABSTRACT
Study the immunological adjuvant function of biodegradable microspheres for DNA immunization. Empty poly(D,L-lactide-co-glycolic acid) microspheres were prepared using the water-inoil-in-water(w-o-w)technique; A plasmid DNA pRc-CMV encoding hepatitis B virus S antigen was constructed;The mixture of the microspheres and the plasmid DNA was prepared by incubation method. The mixture was administered to Balb/c mice by intramuscular injection. Result: The high antibody titer (1:1600) of intramuscular injection of the mixture of microspheres and the plasmid DNA was obtained, similar to that of intramuscular injection of the mixture of AL(OH)3 and hepatitis B virus S antigen; while intramuscular injection the plasmid DNA elicited no serum antibody respones. Conclusion: biodegradable microspheres may be used as an good adjuvant for DNA immunization.