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EMI magazine releases Phase III data of V-01 vaccine, showing significant advantages of sequential boosting
Published Time：
2022-06-14
On June 10, a research paper on Lizhu's "recombinant novel coronavirus fusion protein vaccine" (hereinafter referred to as V-01) was published in the journal Emerging Microbes & Infections. The latest Phase III clinical trial showed that 14 days after receiving a booster dose of V-01, the neutralizing antibody titers in the V-01 vaccine group increased significantly in the primary immunization population who had already received the inactivated vaccine. The experiment confirmed that the heterologous booster immunization of the V-01 vaccine is safe and effective, and can induce strong humoral immunity during the prevalence of Omicron and other variant viruses.
It is understood that this double-blind, placebo-controlled, randomized Phase III clinical trial was conducted in Pakistan and Malaysia to evaluate the efficacy, immunogenicity, and safety of a single dose of V-01 vaccine for heterologous booster immunization within 3-6 months after completion of the basic immunization vaccine. The study has been registered on ClinicalTrials.gov (number: NCT05096832).
As we all know, heterologous boosting has higher immunogenicity than homologous boosting, and can increase the intensity, sustainability, and breadth of the immune response. As expected, in the participants of this trial, heterologous vaccination with the V-01 vaccine elicited a strong neutralizing antibody response, with a GMT of 1452.8 14 days after booster immunization. The safety is significantly better than mRNA vaccines and AZ adenovirus vaccines.
The important conclusions obtained from this heterologous boosting trial may be applied in further optimizing the immunization plans and strategies for controlling the COVID-19 epidemic.
According to previous media reports, V-01 is the world's first COVID-19 vaccine to obtain sequential booster protection efficacy in international multicenter, randomized, double-blind Phase III clinical trials against prevalent strains including Omicron, and is the first to obtain data on the protective efficacy against Omicron mild infections and above. After V-01 vaccination, protection can be rapidly formed, and both sequential boosting and basic immunization show significant protection for high-risk populations, comparable to mRNA vaccines and AZ adenovirus vaccines.
Emerging Microbes & Infections (EMI) is an open-access, fully peer-reviewed international scientific journal dedicated to publishing the best and latest research results in the field of emerging infectious diseases. Co-edited by Academician Wen Yummei of Fudan University and Professor Hans-Dieter Klenk of Philipps University of Marburg, Germany, with Professor Shan Lu of the University of Massachusetts Medical School as executive editor; Academician Xu Jianguo of the Chinese Center for Disease Control and Prevention, Professor Yuan Zhenghong of Fudan University, Professor Tang Yiwei of Cornell University's Sloan Kettering Cancer Center, Professor Zhang Wenhong of Huashan Hospital, Fudan University, and Professor Lorne A. Babiuk of the University of Alberta serve as associate editors.
References:
1. Xuan-Yi Wang, Syed Faisal Mahmood, Fang Jin, Wee Kooi Cheah, Muhammad Ahmad, Mian Amjad Sohail, Waheed Ahmad, Vijaya K Suppan, Muneeba Ahsan Sayeed, Shobha Luxmi, Aik-Howe Teo, Li Yuan Lee, Yang-Yang Qi, Rong-Juan Pei, Wei Deng, Zhong-Hui Xu, Jia-Ming Yang, Yan Zhang, Wu-Xiang Guan & Xiong Yu (2022) Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial, Emerging Microbes & Infections, DOI: 10.1080/22221751.2022.2088406
Literature link:
https://doi.org/10.1080/22221751.2022.2088406
Keywords: V-01; efficacy; heterologous boosting; subunit vaccine; Phase III clinical trial
From: Cailianpress
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