Assessing the reporting quality of randomized controlled trials on COVID-19 vaccines: a systematic review

References

• Han J, Zhang N, Chen D, Gong Y, Li G, Kong Y, Pu L, Chen C, Liu J, Wang Q, et al. Distinct durability of IgM/IgG antibody responses in COVID-19 patients with differing severity. Sci China Life Sci. 2021;2:1–8.
   Google Scholar
• Holmberg C, Blume SS, Greenough PRE. The politics of vaccination: a global history. Manchester: Manchester University Press; 2017. pp. 1–16.
   Google Scholar
• Taleghani N, Taghipour F. Diagnosis of COVID-19 for controlling the pandemic: a review of the state-of-the-art. Biosens Bioelectron. 2021;174:112830. doi:10.1016/j.bios.2020.112830.
   PubMed Web of Science ®Google Scholar
• Lu L, Xiong W, Mu J, Zhang Q, Zhang H, Zou L, Li W, He L, Sander JW, Zhou D. The potential neurological effect of the COVID-19 vaccines: a review. Acta Neurol Scand. 2021;144:3–12. doi:10.1111/ane.13417.
   PubMed Web of Science ®Google Scholar
• Krammer F. SARS- CoV- 2 vaccines in development. Nature. 2020;586:516–27. doi:10.1038/s41586-020-2798-3.
   PubMed Web of Science ®Google Scholar
• Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021;21:e26–e35. doi:10.1016/S1473-3099(20)30773-8.
   PubMed Web of Science ®Google Scholar
• Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, Mayhew S. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020;19:305–06. doi:10.1038/d41573-020-00073-5.
   PubMed Web of Science ®Google Scholar
• González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, Campos P, Varela T, Martínez VVG, Ceriani L, et al. Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reduction of SARS-CoV-2 confirmed infections, hospitalisations and mortality in patients aged 60-79: a retrospective cohort study in Argentina. EClinicalMedicine. 2021;40:101126. doi:10.1016/j.eclinm.2021.101126.
   PubMedGoogle Scholar
• Weinberg GA, Szilagyi PG. Vaccine epidemiology: efficacy, effectiveness, and the translational research roadmap. J Infect Dis. 2010;201:1607–10. doi:10.1086/652404.
   PubMed Web of Science ®Google Scholar
• Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, et al. Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10275):682–94. doi:10.1016/S0140-6736(21)00241-5.
   PubMed Web of Science ®Google Scholar
• Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B; mRNA-1273 Study Group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021;39(20):2791–99. doi:10.1016/j.vaccine.2021.02.007.
   PubMed Web of Science ®Google Scholar
• Stephenson KE, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Truyers C, Atyeo C, Loos C, Chandrashekar A, McMahan K, et al. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021;325(15):1535–44. doi:10.1001/jama.2021.3645.
   PubMed Web of Science ®Google Scholar
• Pan HX, Liu JK, Huang BY, Li GF, Chang XY, Liu YF, Wang WL, Chu K, Hu JL, Li JX, et al. Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials. Chin Med J (Engl). 2021;134(11):1289–98. doi:10.1097/CM9.0000000000001573.
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, et al.; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403–16. doi:10.1056/NEJMoa2035389.
   PubMed Web of Science ®Google Scholar
• Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, Lalloo U, Masilela MSL, Moodley D, Hanley S, et al.; 2019nCoV-501 Study Group. Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021;384(20):1899–909. doi:10.1056/NEJMoa2103055.
   PubMed Web of Science ®Google Scholar
• Emary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, Blane B, Bonsall D, Cicconi P, Charlton S, et al.; COVID-19 Genomics UK consortium; AMPHEUS Project; Oxford COVID-19 Vaccine Trial Group. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021;397(10282):1351–62. doi:10.1016/S0140-6736(21)00628-0.
   PubMed Web of Science ®Google Scholar
• Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, et al. Interim results of a Phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. 2021;384(19):1824–35. doi:10.1056/NEJMoa2034201.
   PubMed Web of Science ®Google Scholar
• Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, et al.; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467–78. doi:10.1016/S0140-6736(20)31604-4.
   PubMed Web of Science ®Google Scholar
• Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, et al.; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021;397(10275):671–81. doi:10.1016/S0140-6736(21)00234-8.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181–92. doi:10.1016/S1473-3099(20)30843-4.
   PubMed Web of Science ®Google Scholar
• Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;586(7830):589–93. doi:10.1038/s41586-020-2639-4.
   PubMed Web of Science ®Google Scholar
• Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, Voysey M, Aley PK, Angus B, Babbage G, et al.; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021;396(10267):1979–93. doi:10.1016/S0140-6736(20)32466-1.
   PubMed Web of Science ®Google Scholar
• Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med. 2020;383(25):2439–50. doi:10.1056/NEJMoa2027906.
   PubMed Web of Science ®Google Scholar
• Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. JAMA. 2020;324(10):951–60. doi:10.1001/jama.2020.15543.
   PubMed Web of Science ®Google Scholar
• Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, et al.; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–15.
   PubMed Web of Science ®Google Scholar
• Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021;21(1):39–51. doi:10.1016/S1473-3099(20)30831-8.
   PubMed Web of Science ®Google Scholar
• Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med. 2020;383(24):2320–32. doi:10.1056/NEJMoa2026920.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, et al.; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 vaccine against the B.1.351 variant. N Engl J Med. 2021;384(20):1885–98. doi:10.1056/NEJMoa2102214.
   PubMed Web of Science ®Google Scholar
• Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, Chen H, Long R, Zhao Z, Mou T, et al. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: a phase I randomized, double-blinded, controlled trial. Vaccine. 2021;39(20):2746–54. doi:10.1016/j.vaccine.2021.04.006.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;396(10249):479–88. doi:10.1016/S0140-6736(20)31605-6.
   PubMed Web of Science ®Google Scholar
• Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, Ganneru B, Sapkal G, Yadav P, Abraham P, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021;21:637–46.
   PubMed Web of Science ®Google Scholar
• Chen Y, Klein SL, Garibaldi BT, Li H, Wu C, Osevala NM, Li T, Margolick JB, Pawelec G, Leng SX. Aging in COVID-19: vulnerability, immunity and intervention. Ageing Res Rev. 2021;65:101205.
   PubMed Web of Science ®Google Scholar
• Shrotri M, Krutikov M, Palmer T, Giddings R, Azmi B, Subbarao S, Fuller C, Irwin-Singer A, Davies D, Tut G, et al. Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of long-term care facilities in England (VIVALDI): a prospective cohort study. Lancet Infect Dis. 2021;21(11):1529–38. doi:10.1016/S1473-3099(21)00289-9.
   PubMed Web of Science ®Google Scholar
• Tartof SY, Slezak JM, Fischer H, Hong V, Ackerson BK, Ranasinghe ON, Frankland TB, Ogun OA, Zamparo JM, Gray S, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. Lancet. 2021;398(10309):1407–16. doi:10.1016/S0140-6736(21)02183-8.
   PubMed Web of Science ®Google Scholar
• Cheng H, Peng Z, Luo W, Si S, Mo M, Zhou H, Xin X, Liu H, Yu Y. Efficacy and Safety of COVID-19 vaccines in Phase III trials: a meta-analysis. Vaccines (Basel). 2021;9:582. doi:10.3390/vaccines9060582.
   PubMed Web of Science ®Google Scholar
• Kirby T. New variant of SARS-CoV-2 in UK causes surge of COVID-19. Lancet Respir Med. 2021;9:e20–e21. doi:10.1016/S2213-2600(21)00005-9.
   PubMed Web of Science ®Google Scholar
• Tang JW, Toovey OTR, Harvey KN, Hui DDS. Introduction of the South African SARS-CoV-2 variant 501Y.V2 into the UK. J Infect. 2021;82:e8–e10. doi:10.1016/j.jinf.2021.01.007.
   PubMed Web of Science ®Google Scholar