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China's COVID-19 vaccine V-01 enters Phase III clinical trials in the Philippines
Published Time：
2021-08-30
Research personnel working in the trial production workshop of the new coronavirus vaccine at Lizhu Bio. (Photo provided by Lizhu Bio) Xinhua News Agency
Xinhua News Agency, Guangzhou, August 30 (Reporters Li Mi, Ma Xiaocheng, Xu Hongyi) A recombinant fusion protein COVID-19 vaccine (V-01) developed and produced in China has been approved for Phase III clinical trials in the Philippines.
The V-01 vaccine was jointly developed by the Institute of Biophysics, Chinese Academy of Sciences, and Lizhu Pharmaceutical Group, located in Guangdong Province, southern China.
V-01 is a recombinant fusion protein vaccine that uses the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein as an antigen. The RBD is the main part of the virus that binds to the ACE2 receptor on the surface of human cells. This binding process allows the virus to enter host cells and cause infection.
The Philippine Food and Drug Administration has approved Phase III clinical trials of the V-01 vaccine to evaluate its safety and efficacy.
The trial has begun recruiting adult participants aged 18 and above in the country, with the first participants enrolled and receiving their first dose on August 25.
Hu Zhenxiang, deputy general manager of Lizhu Bio, told Xinhua News Agency that the V-01 vaccine has obtained interim analysis reports from Phase I and Phase II clinical trials, with satisfactory results.
A total of 1060 participants were enrolled in the Phase I/II clinical trials. In the Phase II clinical trial, 880 people participated, including 440 aged 18-59 and 440 aged 60 and above, with the oldest participant being 83 years old. The results showed that no serious adverse events related to the vaccine were observed. Adverse reactions were mild and self-resolved within 3 days.
In terms of immunogenicity, after two injections of V-01, the seroconversion rate of neutralizing antibodies reached over 97% within a few days.
Hu Zhenxiang pointed out that the V-01 vaccine can rapidly produce an immune response in both the adult and elderly groups, and there was no significant statistical difference in the geometric mean titer of neutralizing antibodies between the two groups. Antibody titer is a key immunological indicator reflecting the antibody response after vaccination.
At the same time, the vaccine also underwent neutralization activity tests against mutant strains of the new coronavirus. Hu Zhenxiang introduced that the results showed that V-01 can effectively neutralize the Delta strain.
The domestic Phase I and Phase II clinical trial data of V-01 were published in July in the journals Emerging Microbes & Infections and the Chinese Medical Journal (English Edition), respectively.
Scientists previously found that the key to the new coronavirus attaching to host cell receptors is the virus's spike protein. The RBD is part of the spike protein, and it binds to host cells to trigger infection.
Wang Ming, an expert in epidemiology at Sun Yat-sen University, compares the COVID-19 virus to a villain, and targeting the RBD is like handcuffing the villain, preventing the virus from entering host cells.
In March, China approved the emergency use of a recombinant protein vaccine developed by the Institute of Microbiology, Chinese Academy of Sciences, and Anhui Zhifei Longcom Biopharmaceutical Co., Ltd.
Compared with other methods of combating viruses, RBD vaccines are relatively easy to produce and scale up because they only require the production of a small part of the viral spike protein, making them more cost-effective and easier to store and transport.
Hu Zhenxiang said that Lizhu's V-01 vaccine has an annual production capacity of 3.5 billion doses.
In addition to the Philippines, the company has also applied for clinical trials of V-01 in more than 10 countries, including Egypt, Indonesia, Russia, Rwanda, South Africa, Pakistan, Malaysia, Turkey, and Mexico. The company plans to conduct clinical trials of booster shots in Malaysia, Turkey, Mexico, and Rwanda.
In May this year, researchers from Peking University and other institutions reported in the journal Cell Research that injecting the RBD recombinant protein vaccine as a third booster shot may be an ideal immunization strategy.
Source: Xinhua News Agency
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