Safety and Immunogenicity of a Heterologous Booster of Protein Subunit Vaccine MVC-COV1901 after Two Doses of Adenoviral Vector Vaccine AZD1222

  1. Shu-Hsing Cheng
  2. Yi-Chun Lin
  3. Cheng-Pin Chen
  4. Chien-Yu Cheng

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Abstract

We report the safety and immunogenicity results in participants administrated with a booster dose of protein subunit vaccine MVC-COV1901 at 12 (Group A) or 24 (Group B) weeks after two doses of AZD1222 (ChAdOx1 nCoV-19). The administration of the MVC-COV1901 vaccine as a booster dose in both groups was generally safe. There were no serious adverse events related to the intervention as adverse events reported were “mild” or “moderate” in nature. In subjects fully vaccinated with two doses of AZD1222, waning antibody immunity was apparent within six months of the second dose of AZD1222. At one month after the MVC-COV1901 booster dose, those who were vaccinated within 12 weeks after the last AZD1222 dose (Group A) had anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers which were 14- and 6.5-fold increased, respectively, when compared to the titer levels on the day of the booster dose. On the other hand, fold-increase a month post-booster in people who had a booster 24 weeks after the last AZD1222 dose (Group B) were 19.5 and 14.0 times for anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers, respectively. Among those who were vaccinated within 12 weeks after the last AZD1222 dose, we also observed 5.2- and 5.6-fold increases in neutralizing titer levels against ancestral strain and Omicron variant pseudovirus after the booster dose, respectively. These results support the use of MVC-COV1901 as a heterologous booster for individuals vaccinated with AZD1222. Furthermore, regardless of the dosing schedule, the combination of AZD1222 primary series and MVC-COV1901 booster can be cost-effective and suitably applied to low- and middle-income countries (LMIC).

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  1. Version published to 10.3390/vaccines10101701
  2. ScreenIT

    SciScore for 10.1101/2021.12.10.21267574: (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.
    RandomizationThis study is a parallel, prospective, randomized, open-label, clinical study to evaluate the immunogenicity, safety, and tolerability of MVC-COV1901 as a booster vaccine in participants that have received two doses of AZD1222.
    BlindingUnique sample identification was used to always maintain blinding at the laboratory and to allow for automated sample tracking and storage.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: On the other hand, the detection and characterization of neutralizing antibodies were performed by central laboratories using validated pseudovirus and/or live virus neutralization assays.

    Table 2: Resources

    Antibodies
    SentencesResources
    Immunogenicity was assessed by measuring anti-SARS-CoV-2 spike IgG antibody and live-SARS-CoV-2 neutralizing assay as previously performed [11].
    anti-SARS-CoV-2 spike IgG
    suggested: None
    Anti-spike IgG titers and neutralizing antibody titers were converted to the WHO Standardized Unit, BAU/mL and IU/mL, respectively.
    Anti-spike IgG
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    After incubating the serum-virus mixture at 37°C for 1 h, it was added to the wells containing Vero E6 cells.
    Vero E6
    suggested: RRID:CVCL_XD71)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT05097053RecruitingA Heterologous 3rd Boost of MVC-COV1901 to Evaluate Immunoge…

    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.

  3. Version published to 10.1101/2021.12.10.21267574 on medRxiv