BCG-CpG-DNA Adjuvant Quality Evaluation Study Of Human Rabies Vaccine

Objective:Rabies is caused by rabies virus infection,is a zoonotic animal-borne infectious disease.People and all warm-blooded animals are susceptible to infection.In recent years,rabies is still one of the highest mortality diseases in infectious diseases,a serious threat to the lives of the people [1].At present,widely-used rabies vaccines don't contain adjuvant ingredients.However,various types of immune adjuvants have been used in human vaccines or are being studied.The new CpG adjuvant human rabies vaccine can enhance humoral immunity,cellular immunity and animal protection level,and enhance the immune protection effect,reduce the use of vaccine antigen.Method:In this paper,regarding the CpG adjuvant human rabies vaccine,we examined the humoral immune response,cellular immune response and the level of protection,to discusse the immunological effect before exposure and after exposure.At the same time,to explore whether the new CpG adjuvant supplemented with rabies vaccine can reduce the dosage of vaccine antigen and human immunoglobulin,it's important to save the cost of vaccine production and treatment.For the study of the pre-exposure immune effect of Cp G adjuvant rabies vaccine,the titer is test by referring to the current version of the Pharmacopoeia of the People's Republic of China.The applicability of this method,which is used to the rabies vaccine titer of the adjuvant vaccine is studied.The establishment of the method is to determinate of CpG adjuvant vaccine.The mice were immunized with different antigens with CpG adjuvant,and the titer was evaluated to evaluate the protective effect.The humoral immune response level of CpG adjuvant vaccine was detected by rapid fluorescence stove suppression test(RFFIT).The spleen cells were stimulated with appropriate antigenic stimulant concentration.The cellular immune response and lymphocyte subgroup typing were detected by enzyme-linked immunospot assay(ELISPOT)and flow cytometry(FCM).The effect of the adjuvant vaccine was evaluated by the LVG Hamster model after the exposure of rabies.Results:The results show that we have established a titer detection method for CpG adjuvant vaccines to correctly evaluate their relative efficacy.RFFIT results showed that the neutralizing antibody titers of the adjuvant vaccine group were higher than those of the vaccine group at all time points.The results of ELISPOT showed that the levels of IFN-? and IL-2 in CpG adjuvant vaccine were higher than those in the control group at 7 d,14 d,28 d and 42 d after immunization.In the LVG Hamster model,the study of the immune effect after exposure showed that the addition of CpG adjuvant could enhance the immune effect.Conclusions:BCG-CpG-DNA adjuvant human rabies vaccine enhances humoral immune response and cellular immune response,under appropriate compatibility conditions,compared to the no adjuvant rabies vaccine.Addition of adjuvant can reduce the amount of antigen used and the use of immunoglobulin.As a new BCG-Cp-DNA adjuvant human rabies vaccine,the new-type vaccine has broad prospects.