[Evaluation on the safety and efficacy of lyophilized purified human rabies vaccine (CTN-Vero-RV)].
OBJECTIVE
To observe the safety and efficacy of lyophilized purified human rabies vaccine CTN-Vero RV, CTN strain produced in Vero cells.


METHODS
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.


RESULTS
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).


CONCLUSIONS
CTN-Vero-RV was safe and effective as well as could generate a persistent immune response.
Chen
Wei
W
Wuhan Institute of Biological Products, Wuhan 430060, China.
Zheng
Xin-xiong
XX
Zhang
Long-ming
LM
Zheng
Jing-shan
JS
Zhang
Liang-hao
LH
Liao
Xue-zhou
XZ
Hong
Kong-qing
KQ
Zhu
Yu-tao
YT
Deng
Hua-fang
HF
Zheng
Xiao-li
XL
Yang
Xiao-ming
XM
Huang
Zuo-lin
ZL
Li
Jun
J
Sun
Wen
W
Xu
Ge-lin
GL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D002522:Chlorocebus aethiops; D005260:Female; D005612:Freeze Drying; D006801:Humans; D008297:Male; D008875:Middle Aged; D011819:Rabies Vaccines / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects; D014709:Vero Cells; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines