Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial

Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial Publisher

Solaymanidodaran M^{1, 2} ; Kalantari S³ ; Banihashemi SR⁴ ; Eshaghi A⁵ ; Nofeli M⁴ ; Mohazzab A^{6, 7} ; Mokhberalsafa L⁸ ; Sadeghi F⁹ ; Mokaram AR⁸ ; Moradi MH⁴ ; Razaz SH⁴ ; Taghdiri M⁴ ; Lotfi M⁹ ; Setarehdan SA⁶ Show All Authors

Solaymanidodaran M^{1, 2}
Kalantari S³
Banihashemi SR⁴
Eshaghi A⁵
Nofeli M⁴
Mohazzab A^{6, 7}
Mokhberalsafa L⁸
Sadeghi F⁹
Mokaram AR⁸
Moradi MH⁴
Razaz SH⁴
Taghdiri M⁴
Lotfi M⁹
Setarehdan SA⁶
Masoumi S¹⁰
Ansarifar A⁶
Ebrahimi S¹¹
Esmailzadehha N⁶
Boluki Z¹²
Khoramdad M⁶
Molaipour L⁶
Rabiei MH¹³
Amiri FB¹⁴
Filsoof S¹⁵
Banivaheb B¹⁵
Derakhshani MR⁶
Bayazidi S⁶
Golmoradizadeh R¹⁶
Shahsavan M⁶
Safari S⁶
Ghahremanzadeh N⁶
Mohseni V⁶
Erfanpoor S⁶
Fallah Mehrabadi MH¹⁷

Show Affiliations

1. Clinical Trial Center, Iran University of Medical Science, Tehran, Iran
2. Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran
3. Departments of Infectious Diseases and Tropical Medicine, Iran University of Medical Sciences, Tehran, Iran
4. Department of Research and Development, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran
5. Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran
6. School of Public Health, Iran University of Medical Sciences, Tehran, Iran
7. Reproductive Biotechnology Research Center, Avicenna Research Institute Tehran, ACECR, Tehran, Iran
8. Department of QA, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran
9. Department of Quality Control, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran
10. Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
11. Department of Infectious Diseases, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran
12. Knowledge Utilization Research Center, Tehran University of Medical Sciences, Tehran, Iran
13. Department of Epidemiology, Faculty of Veterinary Medicine, University of Tehran, Iran
14. Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran
15. School of Medicine, Iran University of Medical Sciences, Tehran, Iran
16. Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
17. Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

Source: Heliyon Published:2024

Abstract

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. © 2024 The Authors

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Style	Citing Format
MLA	Solaymanidodaran M, et al.. "Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial." Heliyon, vol. 10, no. 5, 2024, pp. -.
APA	Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, Mokhberalsafa L, Sadeghi F, Mokaram AR, Moradi MH, Razaz SH, Taghdiri M, Lotfi M, Setarehdan SA, Masoumi S, Ansarifar A, Ebrahimi S, Esmailzadehha N, Boluki Z, ... Fallah Mehrabadi MH (2024). Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial. Heliyon, 10(5), -.
Chicago	Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, Mokhberalsafa L, et al.. "Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial." Heliyon 10, no. 5 (2024): -.
Harvard	Solaymanidodaran M et al. (2024) 'Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial', Heliyon, 10(5), pp. -.
Vancouver	Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, et al.. Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial. Heliyon. 2024;10(5):-.
BibTex	@article{ author = {Solaymanidodaran M and Kalantari S and Banihashemi SR and Eshaghi A and Nofeli M and Mohazzab A and Mokhberalsafa L and Sadeghi F and Mokaram AR and Moradi MH and Razaz SH and Taghdiri M and Lotfi M and Setarehdan SA and Masoumi S and Ansarifar A and Ebrahimi S and Esmailzadehha N and Boluki Z and Khoramdad M and Molaipour L and Rabiei MH and Amiri FB and Filsoof S and Banivaheb B and Derakhshani MR and Bayazidi S and Golmoradizadeh R and Shahsavan M and Safari S and Ghahremanzadeh N and Mohseni V and Erfanpoor S and Fallah Mehrabadi MH}, title = {Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial}, journal = {Heliyon}, volume = {10}, number = {5}, pages = {-}, year = {2024} }
RIS	TY - JOUR AU - Solaymanidodaran M AU - Kalantari S AU - Banihashemi SR AU - Eshaghi A AU - Nofeli M AU - Mohazzab A AU - Mokhberalsafa L AU - Sadeghi F AU - Mokaram AR AU - Moradi MH AU - Razaz SH AU - Taghdiri M AU - Lotfi M AU - Setarehdan SA AU - Masoumi S AU - Ansarifar A AU - Ebrahimi S AU - Esmailzadehha N AU - Boluki Z AU - Khoramdad M AU - Molaipour L AU - Rabiei MH AU - Amiri FB AU - Filsoof S AU - Banivaheb B AU - Derakhshani MR AU - Bayazidi S AU - Golmoradizadeh R AU - Shahsavan M AU - Safari S AU - Ghahremanzadeh N AU - Mohseni V AU - Erfanpoor S AU - Fallah Mehrabadi MH TI - Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial JO - Heliyon VL - 10 IS - 5 SP - EP - PY - 2024 ER -

Style

Citing Format

MLA

Solaymanidodaran M, et al.. "Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial." Heliyon, vol. 10, no. 5, 2024, pp. -.

APA

Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, Mokhberalsafa L, Sadeghi F, Mokaram AR, Moradi MH, Razaz SH, Taghdiri M, Lotfi M, Setarehdan SA, Masoumi S, Ansarifar A, Ebrahimi S, Esmailzadehha N, Boluki Z, ... Fallah Mehrabadi MH (2024). Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial. Heliyon, 10(5), -.

Chicago

Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, Mokhberalsafa L, et al.. "Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial." Heliyon 10, no. 5 (2024): -.

Harvard

Solaymanidodaran M et al. (2024) 'Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial', Heliyon, 10(5), pp. -.

Vancouver

Solaymanidodaran M, Kalantari S, Banihashemi SR, Eshaghi A, Nofeli M, Mohazzab A, et al.. Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial. Heliyon. 2024;10(5):-.

BibTex

@article{ author = {Solaymanidodaran M and Kalantari S and Banihashemi SR and Eshaghi A and Nofeli M and Mohazzab A and Mokhberalsafa L and Sadeghi F and Mokaram AR and Moradi MH and Razaz SH and Taghdiri M and Lotfi M and Setarehdan SA and Masoumi S and Ansarifar A and Ebrahimi S and Esmailzadehha N and Boluki Z and Khoramdad M and Molaipour L and Rabiei MH and Amiri FB and Filsoof S and Banivaheb B and Derakhshani MR and Bayazidi S and Golmoradizadeh R and Shahsavan M and Safari S and Ghahremanzadeh N and Mohseni V and Erfanpoor S and Fallah Mehrabadi MH}, title = {Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial}, journal = {Heliyon}, volume = {10}, number = {5}, pages = {-}, year = {2024} }

RIS

TY - JOUR
AU - Solaymanidodaran M
AU - Kalantari S
AU - Banihashemi SR
AU - Eshaghi A
AU - Nofeli M
AU - Mohazzab A
AU - Mokhberalsafa L
AU - Sadeghi F
AU - Mokaram AR
AU - Moradi MH
AU - Razaz SH
AU - Taghdiri M
AU - Lotfi M
AU - Setarehdan SA
AU - Masoumi S
AU - Ansarifar A
AU - Ebrahimi S
AU - Esmailzadehha N
AU - Boluki Z
AU - Khoramdad M
AU - Molaipour L
AU - Rabiei MH
AU - Amiri FB
AU - Filsoof S
AU - Banivaheb B
AU - Derakhshani MR
AU - Bayazidi S
AU - Golmoradizadeh R
AU - Shahsavan M
AU - Safari S
AU - Ghahremanzadeh N
AU - Mohseni V
AU - Erfanpoor S
AU - Fallah Mehrabadi MH
TI - Safety and Efficacy of Rcp Recombinant Spike Protein Covid-19 Vaccine Compared to Sinopharm Bbibp: A Phase Iii, Non-Inferiority Trial
JO - Heliyon
VL - 10
IS - 5
SP -
EP -
PY - 2024
ER -

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