Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
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Abstract
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SciScore for 10.1101/2021.02.10.21251247: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was reviewed and approved by the South African Health Products Regulatory Authority (SAHPRA, ref 20200407), ethics committees of the University of the Witwatersrand (ref 200501), Cape Town (ref 350/2020), Stellenbosch (ref M20/06/009_COVID-19) and Oxford (ref 35-20) prior to trial initiation and was registered on Clinicaltrials.gov (NCT04444674) and the Pan African Clinical Trials registry (PACTR202006922165132).
Consent: All participants were fully informed about trial procedures and possible risks and signed informed consent prior to enrolment.Sex as a biological variable not detected. Randomization Trial objectives, participants and oversight: In this randomized, … SciScore for 10.1101/2021.02.10.21251247: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was reviewed and approved by the South African Health Products Regulatory Authority (SAHPRA, ref 20200407), ethics committees of the University of the Witwatersrand (ref 200501), Cape Town (ref 350/2020), Stellenbosch (ref M20/06/009_COVID-19) and Oxford (ref 35-20) prior to trial initiation and was registered on Clinicaltrials.gov (NCT04444674) and the Pan African Clinical Trials registry (PACTR202006922165132).
Consent: All participants were fully informed about trial procedures and possible risks and signed informed consent prior to enrolment.Sex as a biological variable not detected. Randomization Trial objectives, participants and oversight: In this randomized, double-blinded, placebo-controlled, multi-site trial conducted in South Africa, we assessed the safety and efficacy of two standard doses of ChAdOx1-nCoV19 administered 21-35 days apart, compared to saline (0.9% NaCl) placebo. Blinding Trial participants and all other study staff remain blinded to treatment group. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources To assess neutralization activity of vaccine-elicited antibodies against B.1.351, 25 serum samples from Group-1 participants who tested seronegative at enrolment but showed varying neutralizing antibody titers at 14 days post 2nd dose of injection were assayed using PSVNA and LVNA before unblinding of study arm allocation.14,21 The PSVNA tested neutralization activity against the original D614G spike, a RBD triple mutant (containing only K417N, E484K, N501Y) and the B.1.351 spike. B.1.351suggested: (LSBio (LifeSpan Cat# LS-B1351-50, RRID:AB_1015723)Experimental Models: Cell Lines Sentences Resources Live virus neutralization assay was performed by a microneutralization focus forming assay in Vero E6 cells. Vero E6suggested: RRID:CVCL_XD71)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04444674 Active, not recruiting COVID-19 Vaccine (ChAdOx1 nCoV-19) Trial in South African Ad… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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Alfonso J. Rodriguez-Morales
Review 1: "Safety and efficacy of the ChAdOx1 nCoV-19 (AZD1222) Covid-19 vaccine against the B.1.351 variant in South Africa"
This preprint suggests the Astra-Zeneca vaccine had little efficacy against non-hospitalized mild to moderate Covid-19 due to B.1.351. Reviewers found it was potentially informative, suggesting the need for more studies to assess vaccine effectiveness against the B.1.351 variant.
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Roy Soiza
Review 3: "Safety and efficacy of the ChAdOx1 nCoV-19 (AZD1222) Covid-19 vaccine against the B.1.351 variant in South Africa"
This preprint suggests the Astra-Zeneca vaccine had little efficacy against non-hospitalized mild to moderate Covid-19 due to B.1.351. Reviewers found it was potentially informative, suggesting the need for more studies to assess vaccine effectiveness against the B.1.351 variant.
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Julian Ruiz-Saenz
Review 2: "Safety and efficacy of the ChAdOx1 nCoV-19 (AZD1222) Covid-19 vaccine against the B.1.351 variant in South Africa"
This preprint suggests the Astra-Zeneca vaccine had little efficacy against non-hospitalized mild to moderate Covid-19 due to B.1.351. Reviewers found it was potentially informative, suggesting the need for more studies to assess vaccine effectiveness against the B.1.351 variant.
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Strength of evidence
Reviewers: Alfonso J. Rodriguez-Morales (Fundacion Universitaria Autonoma de las Americas) | 📗📗📗📗◻️
Julian Ruiz-Saenz (Universidad Cooperativa de Colombia) | 📒📒📒◻️◻️
Roy Soiza (University of Aberdeen) | 📗📗📗📗◻️ -
