Safety, tolerability and immunogenicity of Biological E’s CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study

  1. Subhash Thuluva
  2. Vikram Paradkar
  3. SubbaReddy Gunneri
  4. Vijay Yerroju
  5. Rammohan Reddy Mogulla
  6. Pothakamuri Venkata Suneetha
  7. Kishore Turaga
  8. Mahesh Kyasani
  9. Senthil Kumar Manoharan
  10. Srikanth Adabala
  11. Aditya Sri Javvadi
  12. Guruprasad Medigeshi
  13. Janmejay Singh
  14. Heena Shaman
  15. Akshay Binayke
  16. Aymaan Zaheer
  17. Amit Awasthi
  18. Manish Narang
  19. Pradeep Nanjappa
  20. Niranjana Mahantshetti
  21. Bishan Swarup Garg
  22. Anil Kumar Pandey

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.10.045
  2. ScreenIT

    SciScore for 10.1101/2022.04.20.22274076: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The Investigational Review Board or Ethics Committee at each study site approved the protocol.
    Consent: All participants provided written informed consent before enrollment into the study.
    Sex as a biological variablenot detected.
    RandomizationStudy Design and Study Population: This is an ongoing prospective, randomized, double-blind, placebo controlled, seamless phase-2/3 study to demonstrate safety, reactogenicity & immunogenicity of BE’s CORBEVAX™ vaccine in children and adolescents.
    BlindingParticipants and investigators were blinded to group allocation.
    Power AnalysisThe sample size of 210 evaluable subjects (SAS 9.4) in each age group will give around 87% power at 5% two-sided level of significance to test the GMT ratio between each age group with adult sample data.

    Table 2: Resources

    Antibodies
    SentencesResources
    Participants were healthy children (SARS-CoV-2 RT-PCR and anti-SARS-CoV-2 antibody negative) between <18 to ≥5 years of age.
    anti-SARS-CoV-2
    suggested: None
    Participants who were negative for both SARS CoV-2 infection and Anti-SARS CoV-2 human S1/S2 IgG antibodies were enrolled into the study.
    Anti-SARS CoV-2 human S1/S2 IgG
    suggested: None
    human
    suggested: None
    Software and Algorithms
    SentencesResources
    Procedure: Biological E’s CORBEVAX™ vaccine is a recombinant sub unit vaccine consists of RBD protein as an antigen, CpG 1018 and Aluminium hydroxide as adjuvants formulated in Tris buffer.
    Procedure: Biological
    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:
    Study limitations: Limitations of the current study includes: Long-term safety in pediatric population was not established yet as interim results are available only until day 56. Safety profile of the CORBEVAX™ vaccine will be established up to 6 months after second dose of the vaccination. Immunogenicity of the candidate vaccine was studied but the efficacy of the vaccine against Covid-19 infection was not studied. Also, there is a need for evaluating antibody persistence in longer follow-up period and neutralizing potential against new Omicron variant was not tested in the current study which will be addressed in the future studies. In conclusion, CORBEVAX™ vaccine is safe, well tolerated and elicited excellent antibody and cellular immune responses that can offer significant protection against symptomatic infection from SARS-CoV-2 virus in pediatric population aged 5-17 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 10.1101/2022.04.20.22274076 on medRxiv