An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901
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Abstract
Rapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the world, this has not always been feasible. Recently, the Taiwan Food and Drug Administration, following the consensus of the International Coalition of Medicines Regulatory Authorities (ICMRA), adopted the use of immunobridging studies as acceptable for authorizing COVID-19 vaccines in lieu of efficacy data. Here, we describe a study in which our candidate vaccine, MVC-COV1901, an adjuvanted protein subunit vaccine, has been granted emergency use authorization (EUA) in Taiwan based on a noninferiority immunobridging study. Immunogenicity results from the per protocol immunogenicity (PPI) subset (n = 903) from the MVC-COV1901 phase 2 trial were compared with results from 200 subjects who had received an adenovirus vector vaccine, AstraZeneca ChAdOx nCOV-19 (AZD1222), in a separate study. The lower bound of the 95% confidence interval (CI) of the geometric mean titer (GMT) ratio comparing MVC-COV1901 to AZD1222 was 3.4. The lower bound of the 95% CI of the sero-response rate was 95.5%. Both the GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan.
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SciScore for 10.1101/2022.02.26.22271364: (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 the Taiwan Food and Drug Administration (FDA) and the ethics committees at the participating sites.
IRB: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration (FDA) and the ethics committees at the participating sites.Sex as a biological variable not detected. Randomization Clinical trial and sample population: The MVC-COV1901 phase 2 trial was a prospective, randomized, double-blind, placebo-controlled, and multicenter study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901 (NCT04695652) [4]. Blinding not detected. Power … SciScore for 10.1101/2022.02.26.22271364: (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 the Taiwan Food and Drug Administration (FDA) and the ethics committees at the participating sites.
IRB: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration (FDA) and the ethics committees at the participating sites.Sex as a biological variable not detected. Randomization Clinical trial and sample population: The MVC-COV1901 phase 2 trial was a prospective, randomized, double-blind, placebo-controlled, and multicenter study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901 (NCT04695652) [4]. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources The model included the log-transformed antibody titers at Day 57 as the dependent variable, vaccine group (AZD1222 and MVC-COV1901) as an explanatory variable and adjusted for age, BMI, gender and comorbidity profile. MVC-COV1901suggested: 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:There are a few limitations of this study, first, the design is not randomized, double blinded, but an external comparison, which will compromise the level of evidence. Second, the cell-medicated immunity was not included in the comparative immunogenicity profile. Third, other characterizations that are of interests, including the waning immunity of both vaccines, the cross-reactivity against Variants of Concern (VoCs), were not explored. The data presented in the study showed that it is reasonably likely that the vaccine efficacy of MVC-COV1901 is similar or superior to that of AZ. The data could be used in support of further vaccine development and regulatory approval.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04695652 Completed A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in … 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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