China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the positive results of a Phase II clinical study for its recombinant COVID-19 vaccine ReCOV in the Philippines as a sequential booster shot. The results showed that ReCOV as a sequential booster shot was superior to mRNA vaccine in terms of neutralizing antibody induced against Omicron BA.5 and BA.2 variants and the prototype strain (the difference was statistically significant). The company is making a rolling submission in China.
Study Design and Enrollment
The study was designed to compare the immunogenicity and safety of ReCOV and the Pfizer/BioNTech mRNA vaccine Comirnaty in a population who had completed basic immunization with inactivated vaccines. A total of 600 subjects were enrolled and randomized to receive ReCOV or Comirnaty.
Immunogenicity Results
At 14 days after inoculation, the seroconversion rate (SCR) of the ReCOV group and the mRNA vaccine group against the neutralizing antibody of the prototype strain was 96.0% and 91.0%, respectively. The SCR of the ReCOV group was significantly higher than that of the mRNA vaccine group (P=0.039). At the same time, the geometric mean titers (GMT) of neutralizing antibodies in the ReCOV group and mRNA vaccine group were 7781.8 and 5605.3, respectively. The GMT in the ReCOV group was significantly higher than that in the mRNA vaccine group (P<0.001). In addition, the level of neutralizing antibody induced by the ReCOV group was 25.1 times higher than that of baseline, which was significantly higher than that of the mRNA vaccine (15.7 times).
Safety Profile
As of the date of data analysis, none of the subjects vaccinated with ReCOV reported serious adverse reactions (SAE) or serious treatment emergent adverse events (TEAEs) leading to early withdrawal from the study, nor did they report clinically significant vital signs or clinical laboratory abnormalities.-Fineline Info & Tech
