Walvax Biotechnology Co., Ltd’s (SHE: 300142) mRNA vaccine against SARS-CoV-2, named AWcorna, has reached the Phase III stage in multiple trial centers. The randomized trial (ChiCTR2100053701), led by the Academy of Military Medical Sciences and the Guangzhou Institute of Respiratory Health, enrolled 300 adults who had previously received two doses of inactivated vaccines. Participants were given a booster of either AWcorna or the CoronaVac inactivated vaccine.
Trial Results
The study assessed neutralization and IgG antibody titers against wild-type (WT) SARS-CoV-2 and variants of concern (VOCs) at pre-booster and 14- and 28-day post-booster stages. The AWcorna booster induced a 66.2-fold increase in neutralization antibodies against WT SARS-CoV-2, with geometric mean titers (GMTs) reaching 293.9 and 242.4 at 14 and 28 days post-booster, respectively. In contrast, GMTs in the CoronaVac booster group were only 89.1 and 64.3. Against the Omicron variant, the AWcorna booster group maintained GMTs of 28.1 at day 28, compared to 6.4 for the CoronaVac booster group. Additionally, 83.75% of participants in the AWcorna group achieved the 1:8 threshold of neutralization antibody titers against Omicron, versus 35% in the CoronaVac group.
Conclusion and Ongoing Trials
The study concluded that a third dose of heterologous boosting with AWcorna was safe and protective against circulating Delta and Omicron variants. Ongoing global Phase III trials are evaluating the safety of AWcorna in 28,000 patients. Details of the trial were published in a letter to Cell Research, titled “Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults.”-Fineline Info & Tech
