Evaluation of anti-spike glycoprotein antibody and neutralizing antibody response of different vaccine platforms. A protocol of systematic review and meta-analysis of COVID-19 vaccine clinical trial studies

  1. Mohammad Mirzakhani
  2. Safa Tahmasebi
  3. Mohammadreza Dashti
  4. Mohammad Reza Mohammadi
  5. Manizhe Faghih
  6. Mousa Mohammadnia-Afrouzi
  7. Hadi Esmaeili Gouvarchin Ghaleh
  8. Jafar Amani

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Abstract

Background

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. SARS-CoV-2 transmit among the people fast and infected thousands of people daily around the world. Because of rapid transmission of SARS-CoV-2 among the people, there is an urgent need to prevent people from infection or hospitalization and control the disease.

Methods

We will search electronic databases such as PubMed, Web of Science, Cochrane (CENTRAL), Scopus, Google scholar, the key journals (vaccine and vaccines). Moreover, trial registry including clinicalTrials.gov, WHO ICTRP, and ISRCTN will be searched. We will only select all clinical trial studies in any phases of evaluation (i.e. phase I, II, II, IV). For anti-spike glycoprotein antibody (IgG) response and neutralizing antibody response, we will report Ratio of Geometric Mean (RoGM), Ratio of Mean (RoM) or standardized mean difference (SMD) depends on type of articles.

Discussion

Various vaccine platforms have been developed to increase the resistance to the SARS-CoV2 virus and reduce hospitalization and mortality rates. The comprehensive data gathering and analysis of results will guide scientists about the best available evidence. Moreover, the current study results may indicate which of the vaccine platforms are more effective and safe for COVID-19.

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  1. ScreenIT

    SciScore for 10.1101/2022.05.18.22275247: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    RandomizationAND (randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR placebo[tiab] OR drug therapy[sh] OR randomly[tiab] OR trial[tiab] OR groups[tiab] NOT animals[mh] NOT humans[mh]) AND 2020/01/01:2022/03/30
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Type of outcome measurements: Primary outcomes measurements: For anti-spike glycoprotein antibody (IgG) response and neutralizing antibody response, we will report Ratio of Geometric Mean (RoGM) and/or Ratio of Mean (RoM).
    anti-spike glycoprotein antibody ( IgG
    suggested: None
    anti-spike glycoprotein antibody geometric mean titre (GMT)/geometric mean concentration (GMC)
    anti-spike glycoprotein
    suggested: None
    Software and Algorithms
    SentencesResources
    The sources include electronic database such as PubMed, Web of science, Cochrane (CENTRAL), Scopus, Google scholar, the key journals (vaccine and vaccines).
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    Google scholar
    suggested: (Google Scholar, RRID:SCR_008878)
    Key words and syntax: The main search terms are “SARS-CoV-2 vaccine”, vaccine, “COVID-19 vaccine” and COVID-19 and “Coronavirus disease 2019” that will be searched in MeSH databases.
    MeSH
    suggested: (MeSH, RRID:SCR_004750)
    Risk of bias assessment: Two reviewers independently will conduct quality assessment of primary studies by using checklist of quality assessment for interventional studies (Cochrane risk-of-bias tool).
    Cochrane risk-of-bias tool
    suggested: None

    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:
    As the strengths of this study, we will search several sources without language limitation to achieve the research goal. The sources include electronic databases such as PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Google Scholar, the key journals (vaccine and vaccines). Trial registries, including ClinicalTrials.gov, WHO ICTRP, and ISRCTN, will be searched. In addition, “COVID-19 vaccine tracker and landscape” of WHO, “Cochrane vaccine mapping tool”, and the reference list of included primary will be searched. Also, the publication bias of primary studies will be evaluated. Eventually, we expect that our study notably advances the knowledge about the safety and efficacy of various COVID-19 vaccine platforms.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    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.
    • Thank you for including a protocol registration statement.

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

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2022.05.18.22275247v1 on medRxiv