Immunogenic superiority and safety of Biological E CORBEVAX vaccine compared to COVISHIELD (ChAdOx1 nCoV-19) vaccine studied in a phase III, single blind, multicenter, randomized clinical trial

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   ScreenIT

   Mar 25, 2022

   SciScore for 10.1101/2022.03.20.22271891: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: The Investigational Review Board or Ethics Committee at each study site approved the protocol. Consent: All participants provided written informed consent before enrollment into the study. Field Sample Permit: Serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) if any, were collected during the entire study duration.
   Sex as a biological variable	not detected.
   Randomization	Study Design and Study Population: This is an ongoing phase III prospective, single blinded, randomized, active controlled study conducted at 18 sites across India in accordance with the principles defined in the Declaration of Helsinki, International …

   SciScore for 10.1101/2022.03.20.22271891: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: The Investigational Review Board or Ethics Committee at each study site approved the protocol. Consent: All participants provided written informed consent before enrollment into the study. Field Sample Permit: Serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) if any, were collected during the entire study duration.
   Sex as a biological variable	not detected.
   Randomization	Study Design and Study Population: This is an ongoing phase III prospective, single blinded, randomized, active controlled study conducted at 18 sites across India in accordance with the principles defined in the Declaration of Helsinki, International Conference on Harmonization guidelines (Good Clinical Practices), and the local regulatory guidelines.
   Blinding	Study Design and Study Population: This is an ongoing phase III prospective, single blinded, randomized, active controlled study conducted at 18 sites across India in accordance with the principles defined in the Declaration of Helsinki, International Conference on Harmonization guidelines (Good Clinical Practices), and the local regulatory guidelines.
   Power Analysis	not detected.
   Cell Line Authentication	Authentication: A randomization scheme was generated by using a validated system.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Participants were seronegative to anti-SARS-CoV-2 IgG antibody prior to randomization into immunogenicity arm, whereas in safety arm subjects were randomized irrespective of their serostatus for SARS-CoV-2.	anti-SARS-CoV-2 IgG suggested: None
   6 Participants who were negative for both Anti-SARS CoV-2 human S1/S2 IgG antibodies and SARS CoV-2 infection were enrolled to study immune responses (immunogenicity arm).	Anti-SARS suggested: None human S1/S2 IgG suggested: None
   Outcomes: The primary outcome of the study was demonstration of immunogenic superiority of BE’s CORBEVAX™ vaccine against COVISHIELD™ vaccine in terms of GMTs of anti-SARS-CoV-2 virus neutralizing antibodies at day 42 (14 days after 2nd dose).	anti-SARS-CoV-2 suggested: None
   Anti-RBD antibody concentration in terms of GMC’s and to descriptively assess the safety, tolerability and reactogenicity of CORBEVAX™ vaccine during the study period.	Anti-RBD suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   This vaccine is based on recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein, produced in genetically modified human embryonic kidney (HEK) 293 cells (CDSCO.gov).	HEK suggested: None 293 suggested: NCI-DTP Cat# NCI-293TT, RRID:CVCL_1D85)
   Software and Algorithms
   Sentences	Resources
   This is also a single-blind study where study participants randomized into immunogenicity arm are kept blinded of the vaccination group to which they have been assigned, but the investigator and study staff are aware of the assigned group (CORBEVAX™ or COVISHIELD™). Procedure: Biological E’s CORBEVAX™ vaccine is based on recombinant RBD protein, which is produced in Pichia Pastoris culture as secretory protein and purified via multiple chromatography and ultrafiltration/normal-filtration steps.	Procedure: Biological suggested: None

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Study limitations: This study has several limitations like efficacy of the vaccine against Covid-19 infection was not studied and long-term safety was not established as interim results are available only until day 56. However, it is worth noting that in a small set of patients (n=360) safety was established until 12 months and significantly higher neutralizing antibody titres (nAbs) persisted at least 6 months after second dose of the vaccination when compared to human convalescent serum (HCS).5 Overall, we conclude that CORBEVAX™ is safe, well tolerated and elicited excellent antibody and cellular immune responses that can offer significant protection against symptomatic infection from SARS-CoV-2 virus.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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.

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   Results from scite Reference Check: We found no unreliable references.

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   Version published to 10.1101/2022.03.20.22271891v1 on medRxiv

   Mar 22, 2022