Casino released Phase III data of adenovirus vector COVID-19 vaccine

Casino released Phase III data of adenovirus vector COVID-19 vaccine

Casino released Phase III data of adenovirus vector COVID-19 vaccine. 

45,000 people enrolled, with a critical illness protection rate of 96%! The Lancet announces Phase III clinical data of China’s first adenovirus vector COVID-19 vaccine in 5 major centers in the world

Cansino Biotech Co., Ltd. (hereinafter referred to as “Cansino Bio”, Cansino-U 688185.SH, Cansino Bio-B 06185.HK) recently published a recombinant new coronavirus vaccine in the international authoritative medical journal “The Lancet” ( 5 adenovirus vector) Convidecia ® global ⅲ multi-center clinical trials and eventually efficient interim safety analysis [1] .

Data show that in healthy people aged 18 and above were inoculated one Convidecia ® after safe and effective.

After 14 days, the critical illness protection rate was 96.0%, and the overall protection rate was 63.7% . No serious vaccine-related adverse reactions occurred.

CanSinoBio 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 COVID-19 vaccine, and the proportion of elderly people included is currently the highest in the country (more than 10%) .

The primary efficacy endpoint of the trial for the evaluation of a vaccination Convidecia ® protective efficacy of at least 28 days after the prevention of laboratory-confirmed (PCR positive) is symptomatic of the COVID-19 pneumonia disease, primary safety endpoint was evaluated 52 weeks after vaccine inoculation The incidence of serious adverse events and adverse events requiring medical intervention.

Data show that inoculation 1 Convidecia ® (dose 0.5ml, 5×10 10 VP / mL) 28 days, the overall protection rate 57.5% (95% CI 39.7-70.0) , severe protection rate 91.7% (95% CI 36.1 -99.0); 14 days later, the overall protection rate was 63.7% (95%CI 52.9-72.1), and the severe protection rate was 96.0% (95%CI 70.5-99.5).

The final analysis results of the global multi-center phase III clinical trial reached the protection rate standard recommended by the World Health Organization.

Serious adverse events in the vaccine group and the placebo group had no significant difference in the incidence of the clinical trial and proves Convidecia ® safety of the elderly over 60 years.

Convidecia ® using a vaccination program, can greatly shorten the period of vaccination and vaccines may be between 8 ° C at 2 ° C to long-term storage stability, can significantly reduce the cost of management inoculation.

Convidecia ® effectiveness and convenience to facilitate regional medical scarce resources, greatly reducing the workload borne by the health system. Up to now, Convidecia ® has obtained the multinational China, Mexico, Ecuador, Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, Indonesia, Malaysia and other authorized emergency use or conditional listing approval, helping to quickly build a global immune barrier.

Previously, the results for the COVID-19 sequential vaccination vaccine clinical study conducted by the Jiangsu Provincial Center for Disease Control and Prevention showed that after two doses of inactivated vaccine, revaccination one Convidecia ® as enhanced antibody levels increased by about 78 after 14 days Times [2] .

The clinical trial of CanSino Bio’s COVID-19 vaccine for inhalation has achieved phased results.

Clinical data shows that the combined immunization effect of intramuscular injection and inhalation of adenovirus vector COVID-19 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.

References:

[1]https://doi.org/10.1016/S0140-6736(21)02753-7

[2]https://doi.org/10.1101/2021.09.03.21263062.

Casino released Phase III data of adenovirus vector COVID-19 vaccine

(source:internet, reference only)

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