Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial

  1. Katia Abarca
  2. Carolina Iturriaga
  3. Marcela Urzúa
  4. Nicole Le Corre
  5. Augusto Pineda
  6. Carolina Fernández
  7. Angélica Domínguez
  8. Pablo A. González
  9. Susan M. Bueno
  10. Paulina Donato
  11. Pilar Espinoza
  12. Daniela Fuentes
  13. Marcela González
  14. Paula Guzmán
  15. Paula Muñoz-Venturelli
  16. Carlos M. Pérez
  17. Marcela Potin
  18. Álvaro Rojas
  19. José V. González-Aramundiz
  20. Nicolás M. S. Gálvez
  21. Francisca Aguirre-Boza
  22. Sofía Aljaro
  23. Luis Federico Bátiz
  24. Yessica Campisto
  25. Mariela Cepeda
  26. Aarón Cortés
  27. Sofía López
  28. María Loreto Pérez
  29. Andrea Schilling
  30. Alexis M. Kalergis
  31. on behalf of the CoronaVac03CL Study Group

Reviewed by

Read the full article See related articles

Discuss this preprint

Start a discussion What are Sciety discussions?

Listed in

Log in to save this article

Abstract

Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.

Article activity feed

  1. Version published to 10.3390/vaccines10071082
  2. ScreenIT

    SciScore for 10.1101/2022.02.07.22270215: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the sponsoring institution Ethical Committee (Comité Ético Científico Ciencias de la Salud UC, Pontificia Universidad Católica de Chile, ID 200708006), and each Institutional Ethical Committee of the other sites (Comité Ético Científico Universidad de Los Andes, Comité Ético Científico Facultad de Medicina Clínica Alemana, Universidad del Desarrollo, Comité Ético Científico Hospital Clínico
    Consent: Written informed consent was obtained from each participant before enrollment.
    Sex as a biological variableA urine test was performed on all female participants to assess potential pregnancies, an exclusion criterion.
    RandomizationStudy design and participants: This trial (clinicaltrials.gov NCT04651790) is a multi-center, randomized clinical trial to evaluate two vaccination schedules of CoronaVac®, the Sinovac inactivated SARS-CoV-2 vaccine, in adults in Chile that included health care workers and community participants recruited at eight sites (six in the Metropolitan Region of Santiago and two in the Valparaiso Region).
    BlindingAn independent data and safety monitoring board reviewed the blinded safety and efficacy data.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses were performed using SPSS 17.0.
    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: 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
    NCT04651790RecruitingEfficacy, Safety, and Immunogenicity of Two Vaccination Sche…

    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.

  3. Version published to 10.1101/2022.02.07.22270215 on medRxiv