Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan
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SciScore for 10.1101/2021.08.05.21261532: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: The trial protocol and informed consent form were approved by Taiwan Food and Drug Administration (TFDA) and the ethics committees at the conducting sites (Main review Institutional.
IRB: The trial protocol and informed consent form were approved by Taiwan Food and Drug Administration (TFDA) and the ethics committees at the conducting sites (Main review Institutional.Sex as a biological variable Participants: Participants were male or female adults aged 20 years or over who were healthy or with stable pre-existing medical conditions. Randomization Trial design and oversight: This is an ongoing phase 2, prospective, randomised, double-blind, placebo-controlled (investigator/site staff … SciScore for 10.1101/2021.08.05.21261532: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: The trial protocol and informed consent form were approved by Taiwan Food and Drug Administration (TFDA) and the ethics committees at the conducting sites (Main review Institutional.
IRB: The trial protocol and informed consent form were approved by Taiwan Food and Drug Administration (TFDA) and the ethics committees at the conducting sites (Main review Institutional.Sex as a biological variable Participants: Participants were male or female adults aged 20 years or over who were healthy or with stable pre-existing medical conditions. Randomization Trial design and oversight: This is an ongoing phase 2, prospective, randomised, double-blind, placebo-controlled (investigator/site staff and participants), multi-centre study. Blinding This was a double-blind study in which participants and investigators were blinded to the study intervention. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources The secondary endpoint was to evaluate the anti-Spike IgG antibody titres on Day 29 (the day of second dose), Day 43 (14 days after the second dose), and Day 57 in the PPI Subset. anti-Spike IgGsuggested: NoneExperimental Models: Cell Lines Sentences Resources The serum-virus mixture was incubated at 37 °C for one hour, and then added to the cell plates containing the Vero E6 cells, followed by a further incubation at 37 °C, 5% CO2 incubator for four to five days. Vero E6suggested: NoneSoftware and Algorithms Sentences Resources All statistical analyses were performed using SAS® 9.4 or newer versions (SAS Institute, Cary, NC, USA). SAS®suggested: (SASqPCR, RRID:SCR_003056)SAS Institutesuggested: (Statistical Analysis System, RRID:SCR_008567)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: We detected the following sentences addressing limitations in the study:We acknowledge the limitations of our current study. The low viral transmission rate in Taiwan at the time of the study, coupled with the relatively small size of the placebo group, hindered observation of both vaccine efficacy as the exploratory endpoint and the risk of VAED. The short duration of the follow-up period before the interim analysis prevented us from assessing the durability of immune responses after Day 57; the long-term follow-up will be available upon completion of this phase 2 trial in October 2021. The racial diversity of study participants is restricted to ethnicities in Taiwan. These limitations will be addressed in our phase 3 trials, which will be conducted in regions outside Taiwan where COVID-19 infection rates are high. To conclude, this interim analysis shows that MVC-COV1901 has good safety profiles and promising neutralising antibody titres. MVC-COV1901 is safe, well-tolerated, and rarely causes febrile reactions in both young adults and older adults. MVC-COV1901 induces high neutralising antibody and anti-Spike IgG GMTs, and its seroconversion rate is nearly 100% on Day 57. Using WHO’s IU and BAU conversion models, the predicted clinical efficacy for MVC-COV1901 is comparable for both methods. The phase 2 trial results support the advancement of MVC-COV1901 in subsequent phase 3 trials. MVC-COV1901 has recently been granted EUA in Taiwan.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04695652 Active, not recruiting A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in … Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
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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