Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
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SciScore for 10.1101/2020.12.11.20210419: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Participants were screened for eligibility based on their health status, including their medical history, laboratory findings, vital signs, and physical examination results, and were enrolled after providing signed and dated informed consent forms.
IRB: The trial was approved by the National Regulatory Authority (India) and the respective Ethics Committees and was conducted in compliance with all International Council for Harmonization (ICH) Good Clinical Practice guidelines.Randomization Trial Design and Participants: This is an adaptive randomized double-blind multicenter phase 1 trial to be seamlessly followed by a phase 2 trial to evaluate the … SciScore for 10.1101/2020.12.11.20210419: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Participants were screened for eligibility based on their health status, including their medical history, laboratory findings, vital signs, and physical examination results, and were enrolled after providing signed and dated informed consent forms.
IRB: The trial was approved by the National Regulatory Authority (India) and the respective Ethics Committees and was conducted in compliance with all International Council for Harmonization (ICH) Good Clinical Practice guidelines.Randomization Trial Design and Participants: This is an adaptive randomized double-blind multicenter phase 1 trial to be seamlessly followed by a phase 2 trial to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy male and nonpregnant female volunteers. Blinding Participants, investigators, study coordinators, study-related personnel, and the sponsor were blinded to the treatment group allocation (excluding an unblinded CRO, who was tasked with the dispatch and labeling of vaccine vials and the generation of the master randomization code). Power Analysis not detected. Sex as a biological variable Trial Design and Participants: This is an adaptive randomized double-blind multicenter phase 1 trial to be seamlessly followed by a phase 2 trial to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy male and nonpregnant female volunteers. Table 2: Resources
Software and Algorithms Sentences Resources Sample size estimation was performed using PASS 13 software (Number Cruncher Statistical Systems, USA), and descriptive and inferential statistics were performed using SAS 9.2. PASSsuggested: (PASS, RRID:SCR_005490)Number Cruncher Statistical Systemssuggested: NoneResults 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: We detected the following sentences addressing limitations in the study:This study has a few limitations. First, as this is an interim report, we are not reporting any data on the persistence of vaccine-induced antibody responses or safety outcomes. Second, the results reported here do not permit efficacy assessments. Third, the evaluation of safety outcomes requires more extensive Phase 3 clinical trials. Last, we evaluated an accelerated schedule (vaccination occurred 2 weeks apart) and did not include a routine schedule (vaccination occurring 4 weeks apart). The latter schedule is being evaluated in Phase 2 (27). However, this study has several strengths. To ensure generalizability, this study was conducted with participants from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. Despite the fact that enrollment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97%. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety. BBV152 induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. BBV152 is stored between 2°C and 8°C, which is compatible with all national immunization programs. Both Algel-IMDG formulations were selected for the phase 2 immunogenicity trials. Further efficacy trials are underway...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04471519 Active, not recruiting Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COV… 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.
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SciScore for 10.1101/2020.12.11.20210419: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Participants were screened for eligibility based on their health status, including their medical history, laboratory findings, vital signs, and physical examination results, and were enrolled after providing signed and dated informed consent forms. Randomization A total of 375 participants were randomized equally to receive three vaccine formulations (n=100 each) prepared with 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel, and an Algel only control arm (n=75). Blinding Participants, investigators, study coordinators, study-related personnel, and the sponsor were blinded to the treatment group allocation (excluding an unblinded CRO, who was tasked … SciScore for 10.1101/2020.12.11.20210419: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Participants were screened for eligibility based on their health status, including their medical history, laboratory findings, vital signs, and physical examination results, and were enrolled after providing signed and dated informed consent forms. Randomization A total of 375 participants were randomized equally to receive three vaccine formulations (n=100 each) prepared with 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel, and an Algel only control arm (n=75). Blinding Participants, investigators, study coordinators, study-related personnel, and the sponsor were blinded to the treatment group allocation (excluding an unblinded CRO, who was tasked with the dispatch and labeling of vaccine vials and the generation of the master randomization code). Power Analysis not detected. Sex as a biological variable Methods Trial Design and Participants This is an adaptive randomized double-blind multicenter phase 1 trial to be seamlessly followed by a phase 2 trial to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy male and nonpregnant female volunteers. Table 2: Resources
Antibodies Sentences Resources Figure 3: SARS-CoV-2 Antibody Responses (Anti S1, RBD, and N IgG) Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) results at baseline (day 0) and 2 weeks after the second vaccination (day 28) for the 3 µg (n=99) and 6 µg (n=99) with Algel-IMDG groups, the 6 µg with Algel group (n=93), and the Algel-only control arm (n=73). Anti S1suggested: NoneSoftware and Algorithms Sentences Resources Sample size estimation was performed using PASS 13 software (Number Cruncher Statistical Systems, USA), and descriptive and inferential statistics were performed using SAS 9.2. PASSsuggested: (PASS, RRID:SCR_005490)Number Cruncher Statistical Systemssuggested: NoneResults 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: We detected the following sentences addressing limitations in the study:
This study has a few limitations. First, as this is an interim report, we are not reporting any data on the persistence of vaccine-induced antibody responses or safety outcomes. Second, the results reported here do not permit efficacy assessments. Third, the evaluation of safety outcomes requires more extensive Phase 3 clinical trials. Last, we evaluated an accelerated schedule (vaccination occurred 2 weeks apart) and did not include a routine schedule (vaccination occurring 4 weeks apart). The latter schedule is being evaluated in Phase 2 (27). However, this study has several strengths. To ensure generalizability, this study was conducted with participants from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. Despite the fact that enrollment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97%. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety. BBV152 induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. BBV152 is stored between 2°C and 8°C, which is compatible with all national immunization programs. Both Algel-IMDG formulations were selected for the phase 2 immunogenicity trials. Further efficacy trials are underway...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04471519 Active, not recruiting Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COV... 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.
About SciScore
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