(Fighting against New Coronary Pneumonia) Phase I clinical trial results of China's nebulized inhalation new crown vaccine: cellular immune response is equivalent to injection
China News Service, Beijing, July 28 (Wang Jingyi, Guan Tong) On July 26, Beijing time, a team led by Chen Wei, an academician of the Chinese Academy of Engineering and a researcher at the Academy of Military Medicine of the Academy of Military Sciences, developed a recombinant new crown vaccine for nebulization (adenovirus vector). ) Phase I clinical trial data, published online in the international authoritative medical journal "The Lancet · Infectious Diseases".
This is the first published clinical trial result of the new crown vaccine mucosal immunity in the world.
The research results show that the recombinant new crown vaccine for aerosol inhalation has good safety, tolerability and immunogenicity.
A dose of aerosolized inhalation vaccine requires only one-fifth of the vaccine dose intramuscularly, and the level of cellular immune response produced is equivalent to that of intramuscular injection.
Nebulized inhalation booster immunization on the 28th day after intramuscular injection of recombinant new crown vaccine can induce the production of high levels of neutralizing antibodies.
The clinical trial was launched in Wuhan on September 29, 2020. It was jointly completed by Chen Wei's team and Wuhan University Zhongnan Hospital. The phase II clinical trial is progressing in an orderly manner.
The aerosol inhalation vaccine is the same as the recombinant new crown vaccine that has been approved for marketing with conditions in terms of preparation formula and production process.
Compared with the cellular and humoral immunity formed by the injectable new crown vaccine, the nebulized vaccine can induce mucosal immunity in the human body, preventing infection and blocking transmission at the first pass of virus invasion.
The vaccinators do not need to "inject", they only need to inhale the vaccine into the respiratory tract and lungs through the atomized inhalation device, so as to obtain the "triple protection" of mucosal immunity, cellular immunity, and humoral immunity.
According to Hou Lihua, a researcher at the Academy of Military Medicine of the Academy of Military Sciences, aerosolized inhalation vaccines can be vaccinated only by "inhalation", which is safer and more convenient, and is suitable for large-scale population promotion.
It is understood that the recombinant new coronavirus vaccine (adenovirus vector) led by Chen Wei’s team has been conditionally approved for marketing by the China National Medical Products Administration on February 25. It is China’s first domestically-made adenovirus vector new coronavirus vaccine approved. Good protection effect can be obtained 14 days after single injection inoculation, and it can be transported and stored at 2°C to 8°C.
The vaccine has now obtained emergency use licenses in Mexico, Pakistan, Hungary, Chile, Argentina and other countries.
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