The critical illness protection rate is 96.0%, the first domestic adenovirus vector new crown vaccine global multi-center phase III clinical data announced

Cansino Biotech Co.
, Ltd.
(hereinafter referred to as "Cansino Bio", Cansino-U688185.
SH, Cansino Bio-B06185.
HK) recently published a recombinant new coronavirus vaccine (type 5) in the international authoritative medical journal "The Lancet" Adenovirus vector) The final effective rate and interim safety analysis results of the global multi-center phase III clinical trial of Kevisa®
.
The data shows that it is safe and effective to inoculate a dose of Kevisa® in healthy people 18 years and older
.
After 14 days, the critical illness protection rate was 96.
0%, the overall protection rate was 63.
7%, and no serious vaccine-related adverse reactions occurred
.
CanSino Bio has carried out a randomized, double-blind, placebo-controlled global multi-center phase III clinical trial in five major research centers in Argentina, Chile, Mexico, Pakistan, and Russia.
A total of 45,000 people were enrolled, which is the current sample size in China.
The largest clinical trial of the new crown vaccine, and the proportion of elderly people included is currently the highest in the country (more than 10%)
.
The main efficacy endpoint of the test is to evaluate the protective efficacy of preventing laboratory-confirmed (PCR positive) symptomatic new coronary pneumonia disease at least 28 days after vaccination of 1 dose of Kevisa®.
The main safety endpoint is to evaluate the efficacy within 52 weeks after vaccination.
The incidence of serious adverse events and adverse events requiring medical intervention
.
The data showed that 28 days after vaccination with 1 dose of Kevisa® (dose 0.
5ml, 5x1010VP/mL), the overall protection rate was 57.
5% (95%CI39.
7-70.
0), and the severe protection rate was 91.
7% (95%CI36.
1).
-99.
0); 14 days later, the overall protection rate was 63.
7% (95%CI52.
9-72.
1), and the severe protection rate was 96.
0% (95%CI70.
5-99.
5)
.
The final analysis results of the global multi-center phase III clinical trial reached the protection rate standard recommended by the World Health Organization
.
There was no significant difference in the incidence of serious adverse events between the vaccine group and the placebo group.
The clinical trial also proved the safety of Kevisa® in the elderly over 60
.
Kevisa® adopts a one-dose vaccination program, which can greatly shorten the vaccination cycle, and the vaccine can be stored and transported stably between 2°C and 8°C for a long time, which can greatly reduce the cost of vaccination management
.
The effectiveness and convenience of Kevisa® provide convenience for areas with scarce medical resources and greatly reduce the workload of the medical and health system
.
Up to now, Kevisa® has obtained emergency use authorization or conditional listing approval in China, Mexico, Ecuador, Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, Indonesia, Malaysia and other countries, helping the world to quickly build an immune barrier
.
Previously, the results of a clinical study on the sequential vaccination of the new crown vaccine carried out by the Jiangsu Provincial Center for Disease Control and Prevention showed that after two doses of inactivated vaccine, another dose of Kevisa® was used as a booster, and the antibody level increased by about 78 days after 14 days.
Times
.
The clinical trial of CanSino Bio's new crown vaccine for inhalation has achieved phased results
.
Clinical data shows that the combined immunization effect of intramuscular injection and inhalation of the adenovirus vector new crown vaccine is better than that of simple intramuscular injection.
The level of neutralizing antibody at 28 days after immunization is 4 times that of single needle intramuscular injection, and for 6 months After the antibody level remained at the peak level
.
In addition, the aerosol inhalation route of administration trains the body's immune memory function by imitating the natural infection of the virus, which can effectively stimulate the triple protection of mucosal immunity, humoral immunity and cellular immunity
.