Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers

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Abstract

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1–2 IgG antibodies in plasma. This observational study included a subgroup analysis of patients who were immunized with Ad5-nCoV in a northern city of Mexico. During follow-up, some patients self-reported having received a BNT162b2 booster. We report baseline IgG levels, 21–28 days after the Ad5-nCoV dose, three months, and an additional 21–28 days after BNT162b2 (four months after Ad5-nCoV). Seventeen patients, age 40 (16), 52.9% men, were analyzed. We created four groups: G1 and G2 refer to patients without a history of SARS-CoV-2 infection, vaccinated with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 4 and n = 6), respectively; G3 and G4 included patients with a history of SARS-CoV-2 infection and immunized with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 5 and n = 2), respectively. The Ad5-nCoV/BNT162b2 protocol reported higher antibody titers after 21–28 days. Median (IQR) values were: G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p < 0.05). Headache and pain at injection site were the most frequent adverse reactions associated with Ad5-nCoV (n = 10, 83%) and BNT162b2 (n = 5, 83.3%), respectively. Patients receiving BNT162b2 after Ad5-nCoV had higher SARS-CoV-2 spike 1–2 IgG antibody titers and had no severe adverse reactions.

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  1. SciScore for 10.1101/2021.10.07.21264657: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the local Institutional Review Board (Ref.:26022021-CN-1e-CI) and conducted per The Code of Ethics of the World Medical Association (Declaration of Helsinki) for human experiments.
    Consent: Due to the prospective nature of the study, every patient had to sign an informed consent form to participate.
    Sex as a biological variableThe inclusion criteria were: individuals of both genders, between the ages of 18 and 100 years, who had signed up the informed consent form and planned to conclude the immunization regimen of any vaccine given by the Mexican National Health System in compliance with the current immunization regimens.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    After explaining the study to each patient, emphasizing the follow-up along an entire year through SARS-CoV-2 specific IgG antibodies measurement samples, all participants provided written informed consent.
    SARS-CoV-2 specific IgG
    suggested: None
    Therefore, after 21-28 days of receiving prime-boost vaccination, the research team contacted the participants to take the second plasma sample for IgG antibodies measurement.
    IgG
    suggested: None
    After completing the vaccine regimen, the follow-up questionnaires on the fourth, fifth and sixth IgG antibody samples asked about any suspicious or confirmed SARS-COV-2 infections.
    sixth IgG
    suggested: None
    It used chemiluminescence immunoassay (CLIA) technology to determine the amount of specific anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 in plasma samples.
    anti-S1
    suggested: None
    anti-S2 IgG
    suggested: None
    The analyzed biochemical variables were SARS-CoV-2 quantitative antibodies from the basal sample (S1), 21-28 days post-Ad5-nCoV (S2), three-month follow-up after immunization (S3), and 21-28 days post-first BNT-boost (S4).
    S3
    suggested: None
    S4
    suggested: None
    Software and Algorithms
    SentencesResources
    The statistical program used was SPSS, version 2.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    A limitation of this investigation is the sample size. So further prospective studies must recruit a more significant sample. Another limitation was the time between both vaccines. It could have more relevance to justify the time lapses, but it was established according to the patients’ access to another vaccine.

    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.
    • No protocol registration statement was detected.

    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.