Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial.

Background

We conducted a phase III, non-inferiority trial comparing safety and efficacy of RCP recombinant spike protein Covid-19 vaccine to BBIBP (Sinopharm).

Methods

Adult Iranian population received RCP or BBIBP in a randomized, double blind and an additional non-randomized open labeled trial arms. Eligible participants signed a written informed consent and received two intramuscular injections three weeks apart. In the randomized arm, an intranasal dose of vaccine or adjuvant-only preparation were given to the RCP and BBIBP recipients at day 51 respectively. Participants were actively followed for up to 4 months for safety and efficacy outcomes. Primary outcome was PCR + symptomatic Covid-19 disease two weeks after the second dose. The non-inferiority margin was 10% of reported BBIBP vaccine efficacy (HR = 1.36).

Results

We recruited 23,110 participants (7224 in the randomized and 15,886 in the non-randomized arm). We observed 604 primary outcome events during 4 months of active follow-up including 121 and 133 in the randomized and 157 and 193 cases in the non-randomized arms among recipients of RCP and BBIBP respectively. Adjusted hazard ratios for the primary outcome in those receiving RCP compared with BBIBP interval were 0.91 (0.71-1.16) and 0.62 (0.49-0.77) in the randomized and non-randomized arms respectively. The upper boundary of 99.1% confidence interval of HR = 0.91 (0.67-1.22) remained below the margin of non-inferiority in the randomized arm after observing the early stopping rules using O'Brien Fleming method.

Conclusion

Our study showed that the RCP efficacy is non-inferior and its safety profile is comparable to the BBIBP.

Informations de copyright

© 2024 The Authors. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

The Iran University of Medical Sciences Clinical Trial Center (IUMS-CTC), were primarily responsible for the conduct of the trial. SRB, AE, MN, ARM, LMS, FS, MHM, SHR, MT, MB, ML, AK, AG, and MHFM were Razi Vaccine and Serum Research Institute, employees. SRB is the inventor of the RCP vaccine. MSD, SK,AM,SAS,SM, AA,SE,NE,ZB, MK, MLP,SE,MHR,FBA, BBV,SF,MRD,ShB,RG,MS,SS,NG, and VM are employees or postgraduate students in IUMS.