Safety and Immunogenicity of the BBIBP-CorV Vaccine in Adolescents Aged 12 to 17 Years in the Thai Population: An Immunobridging Study

  1. Kriangkrai Tawinprai
  2. Taweegrit Siripongboonsitti
  3. Thachanun Porntharukchareon
  4. Preeda Vanichsetakul
  5. Saraiorn Thonginnetra
  6. Krongkwan Niemsorn
  7. Pathariya Promsena
  8. Manunya Tandhansakul
  9. Naruporn Kasemlawan
  10. Natthanan Ruangkijpaisal
  11. Narin Banomyong
  12. Nanthida Phattraprayoon
  13. Teerapat Ungtrakul
  14. Kasiruck Wittayasak
  15. Nawarat Thonwirak
  16. Kamonwan Soonklang
  17. Gaidganok Sornsamdang
  18. Nithi Mahanonda

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Abstract

Adolescents can develop a severe form of Coronavirus disease 2019 (COVID-19), especially with underlying comorbidities. No study has examined the efficacy or effectiveness of inactivated COVID-19 vaccines in adolescents. This single-center, prospective cohort study was performed to evaluate the safety and effectiveness of an inactivated COVID-19 vaccine in adolescents using the immunobridging approach at Chulabhorn Hospital. The key eligibility criterion was a healthy clinical condition or stable pre-existing comorbidity. The anti-receptor-binding domain (anti-RBD) antibody concentration at 4 weeks after dose 2 of the vaccine was compared between participants aged 12 to 17 years and those aged 18 to 30 years. Safety profiles included adverse events within 7 days after each dose of the vaccine and any adverse events through 1 month after dose 2 of the vaccine. In the adolescent and adult cohorts, the geometric mean concentration of anti-RBD antibody was 102.9 binding antibody unit (BAU)/mL (95% CI, 91.0–116.4) and 36.9 BAU/mL (95% CI, 30.9–44.0), respectively. The geometric mean ratio of the adolescent cohort was 2.79 (95% CI, 2.25–3.46, p < 0.0001) compared with the adult cohort, meeting the non-inferiority criterion. The reactogenicity was slightly lower in the adolescent than in the adult cohort. No serious adverse events occurred. The inactivated COVID-19 vaccine appears safe and effective in adolescents.

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  1. Version published to 10.3390/vaccines10050807
  2. ScreenIT

    SciScore for 10.1101/2022.01.07.22268883: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants and parents were informed consent.
    IRB: The study protocol, informed consent, and case record form were reviewed and approved by the Ethics Committee for Human Research, Chulabhorn Research Institute (reference number: 123/2564).
    Sex as a biological variablenot detected.
    RandomizationThe data of the comparison adult cohort, aged 18-30 years, were randomly selected from the prior safety and immunogenicity study of the BBIBP-CorV vaccine in adult participants in our institute.
    Blindingnot detected.
    Power AnalysisSample size: A sample of 250 participants in each cohort was estimated for providing 80% power, 0.05 type I error, and 25% dropout for declaring non-inferiority. (10) Non-inferiority was defined as a lower limit of the two-side 95% confidence interval of geometric mean ratio > 0.67.

    Table 2: Resources

    Antibodies
    SentencesResources
    Statistical methods: The anti-RBD antibody’s geometric mean concentration (GMC) was calculated by exponential the arithmetic means of the logarithm of anti-RBD antibody concentration.
    anti-RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using IBM GraphPad Prism version 9 and SPSS statistic version 26.
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    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:
    (19) This study had some limitations. First, we conducted a prospective cohort study of adolescents compared with our previous study of adult participants instead of a parallel clinical trial. Most adult participants were vaccinated when the study started. It was difficult to enroll the adult participants without prior vaccination with the COVID-19 vaccine. So, there is a difference in the case record form between the adolescent and adult cohorts. There is only a single questionnaire for local reaction in the adult cohort. However, the other solicited adverse events were the same. Second, we used the text message questionnaires instead of the diary book. Some participants in the adolescent cohort did not respond to the questionnaires about safety profiles. This limitation may improve by the active contact with the participants that do not complete the questionnaires. In conclusion, vaccination with the BBIBP-CorV vaccine in the adolescent participants was safe and more robust immune response than adults aged 18-30 years.

    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.

  3. Version published to 10.1101/2022.01.07.22268883v1 on medRxiv