The establishment of a rapid fluorescent focus inhibition test for testing rabies virus neutralizing antibody / 中华流行病学杂志

Objective To establish a rapid fluorescent inhibition test (RFFIT) for testing rabies virus neutralizing antibody and the titer of rabies virus neutralizing antibody.CVS-11 was used as the standard challenge virus,and three generations prepared for the establishment of the virus library.Methods International standard for rabies immunoglobulin was used as the reference serum.RFFIT test was established under consulting the protocol of Institute of Pasteur,and its specificity,stability and reproducibility were validated.Results We established the RFFIT which showed both good specificity ( 100% ) and reproducibility (P＞0.5).Conclusion The establishment of RFFIT test perfected the rabies laboratory techniques and would enhance the overall ability in detecting rabies in China.

Evaluation on the safety and efficacy of lyophilized purified human rabies vaccine (CTN-Vero-RV) / 中华流行病学杂志

<p><b>OBJECTIVE</b>To observe the safety and efficacy of lyophilized purified human rabies vaccine CTN-Vero RV, CTN strain produced in Vero cells.</p><p><b>METHODS</b>450 healthy volunteers were divided into two groups, with 300 of them receiving CTN-Vero-RV (rabies vaccine for human use made in Vero cells with CTN strain) while 150 of them receiving PVRV to serve as control group. All the subjects were immunized on days 0, 3, 7, 14 and 28 at deltoid muscle respectively. Local and systemic reactions were observed and sera were collected for neutralizing antibody testing using RFFIT. 365 and 730 days after the first dose, sera from the 212 and 176 subjects of the studied group while 97 and 80 subjects from the control group were collected to test for neutralizing antibody.</p><p><b>RESULTS</b>No severe local or systemic reactions were observed after immunization was performed in the two groups. On days 3, 7, 14, 28 and 365 after the first dose, the antibody positive rates appeared to be 2.35%, 80.78%, 100.00%, 100.00%, 98.58% and 73.30% in the study group and 4.00%, 87.20%, 100.00%, 100.00%, 97.94% and 76.25% in the controls respectively. On day 0, 3, 7, 14, 28, 365 and 730, GMT of the neutralizing antibody level were 0.12, 1.01, 9.83, 12.61, 3.68 and 2.81 IU/ml in the study group while 0.13, 1.18, 10.24, 11.61, 4.18 and 1.92 IU/ml were seen in the control group respectively. There were no significant differences in both antibody positive rates and GMT between the two groups on days 3, 7, 14, 28, 365 or 730 (P > 0.05).</p><p><b>CONCLUSION</b>CTN-Vero-RV was safe and effective as well as could generate a persistent immune response.</p>