دورية أكاديمية
Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial
| العنوان: | Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial |
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| المؤلفون: | Masoud Solaymani-Dodaran, Saeed Kalantari, Seyed Reza Banihashemi, Ali Es-haghi, Mojtaba Nofeli, Arash Mohazzab, Ladan Mokhberalsafa, Fariba Sadeghi, Ali Rezae Mokaram, Monireh Haji Moradi, Seyad Hossein Razaz, Maryam Taghdiri, Mohsen Lotfi, Seyed Amin Setarehdan, Safdar Masoumi, Akram Ansarifar, Saeedeh Ebrahimi, Neda Esmailzadehha, Zahra Boluki, Malihe Khoramdad, Leila Molaipour, Mohamad Hassan Rabiei, Fahimeh Bagheri Amiri, Sara Filsoof, Behrooz Bani-vaheb, Maryam Raghami Derakhshani, Sheno Bayazidi, Rezvan Golmoradizadeh, Masoumeh Shahsavan, Shiva Safari, Neda Ghahremanzadeh, Vahideh Mohseni, Saeed Erfanpoor, Mohammad Hossein Fallah Mehrabadi |
| المصدر: | Heliyon, Vol 10, Iss 5, Pp e27370- (2024) |
| بيانات النشر: | Elsevier, 2024. |
| سنة النشر: | 2024 |
| المجموعة: | LCC:Science (General) LCC:Social sciences (General) |
| مصطلحات موضوعية: | Razi-cov-pars, BBIBP, Non-inferiority design, Recombinant Covid-19 vaccine, Vaccine efficacy, Phase III clinical trial, Science (General), Q1-390, Social sciences (General), H1-99 |
| الوصف: | 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. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2405-8440 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2405844024034017; https://doaj.org/toc/2405-8440 |
| DOI: | 10.1016/j.heliyon.2024.e27370 |
| URL الوصول: | https://doaj.org/article/13e897bb535f450aaf041ebcfa8c5443 |
| رقم الأكسشن: | edsdoj.13e897bb535f450aaf041ebcfa8c5443 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 24058440 |
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| DOI: | 10.1016/j.heliyon.2024.e27370 |