Meta analysis on the safety and immunogenicity of domestic varicella vaccine among Chinese population

Abstract:

Objective：To evaluate on safety and immunogenicity of domestic varicella vaccine among Chinese population. Methods：The published studies related to safety and immunogenicity of varicella vaccine between January 1996 and June 2010 were searched，sup－plementing by handwork retrieval，search on the internet and references track. Studies were included in the review if they were ran－domized controlled trials（RCTs） between domestic and imported varicella vaccine or among different brands of domestic varicella vac－cines. Statistical analyses were conducted by using RevMan 5.0 software. Results：Seven RCTs were included，among which there are 5 Rcts between domestic and imported varicella vaccine and 3 Rcts among different brands of domestic varicella vaccines. Between domestic and imported vaccine，Meta analysis showed that there was no statistically significant difference in the local reaction inci－dences with OR being 0.74 and 95%CI ranging from 0.37 to 1.49（Z=0.83，P=0.40），there was no statistically significant difference in the systemic fever reaction incidence with OR being 2.34 and 95%CI ranging from 1.5 to 3.64（Z=3.75，P=0.000 2），there was no sta－tistically significant difference in the other systemic reaction incidences with OR being 0.56 and 95%CI ranging from 0.18 to 1.70（Z=1.03，P=0.30）. Among different brands of domestic vaccines，there was no statistically significant difference in the local reaction incidences with OR being 0.91 and 95%CI ranging from 0.43 to 1.91（Z=0.26，P=0.80），there was no statistically significant difference in the systemic fever reaction incidences with OR being 0.80 and 95%CI ranging from 0.59 to 1.08（Z=1.44，P=0.15），there was no sta－tistically significant difference in the other systemic reaction incidences with OR being 0.89 and 95%CI ranging from 0.50 to 1.59（Z=0.40，P=0.69）. Between domestic and imported vaccine，there was no statistically significant difference in the serum antibody se－roconversion incidences with OR being 1.41 and 95%CI rang－ing from 0.69 to 2.87（Z=0.94，P=0.35）. Among different brands of domestic vaccines，there was no statistically significant differ－ence in the serum antibody seroconversion incidenecs with OR being 3.41 and 95%CI ranging from 0.82 to 14.19（Z=1.68，P=0.09）. Conclusions：Domestic varicella vaccine has the same immune effect as imported varicella vaccine. In respect of immune safety，be－sides higher incidences of systemic fever reaction，other local or systemic reactions of domestic varicella vaccine are good. There is no statistical significance in safety and immunogenicity between domestic varicella vaccines. Domestic varicella vaccine can be regarded as the candidate vaccine for children in respect of its effectiveness，safety and cost-saving.