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An Effectiveness Study of the Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine (Projeto S)

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ClinicalTrials.gov Identifier: NCT04747821
Recruitment Status : Active, not recruiting
First Posted : February 10, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Butantan Institute

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE February 10, 2021
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE February 7, 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
Incidence of COVID-19 cases after two-doses immunization schedule in clusters in the first quarter of study [ Time Frame: Thirteen weeks after the beginning of study vaccination ]
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to thirteen weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Incidence of COVID-19 cases after two-doses immunization schedule in clusters up to one year of study [ Time Frame: One year after the beginning of study vaccination ]
    Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year
  • Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to immunization status [ Time Frame: One year after the beginning of study vaccination ]
    Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to immunization status
  • Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to pre-existing SARS-CoV-2 antibodies [ Time Frame: One year after the beginning of study vaccination ]
    Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to pre-existing SARS-CoV-2 antibodies
  • Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to immunization coverage [ Time Frame: One year after the beginning of study vaccination ]
    Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to immunization coverage
  • Incidence of hospitalization and death due to COVID-19 after two-doses immunization schedule in clusters [ Time Frame: One year after the beginning of study vaccination ]
    Number of hospitalization and death due to COVID-19 six weeks after beginning of study vaccination up to one year
  • Change in average number of reported COVID-19 cases in the study area in comparison to other neighboring cities [ Time Frame: One year after the beginning of study vaccination ]
    Average number of reported COVID-19 cases in the microregion where the study area is located
  • Medically-attended adverse reactions to the study vaccine [ Time Frame: One week after each vaccination ]
    Number of medically-attended adverse reactions to the study vaccine
  • Frequency of severe COVID-19 cases [ Time Frame: From first vaccination up to one year after first dose ]
    Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine
  • Frequency of adverse events of special interest after immunization [ Time Frame: From first vaccination up to one year after first dose ]
    Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine
  • Acceptability of the study vaccine [ Time Frame: Two weeks after the beginning of study vaccination of the corresponding cluster ]
    Acceptability rate of the study vaccine in the eligible population of each cluster
  • Adherence to vaccination schedule [ Time Frame: Six weeks after the beginning of study vaccination of the corresponding cluster ]
    Adherence rate to vaccination schedule in the population of each cluster
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2021)
Frequency of SARS-CoV-2 variants in the study area [ Time Frame: One year after the beginning of study vaccination ]
Description of SARS-CoV-2 variants sequenced out of the samples collected in the study area
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Effectiveness Study of the Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine
Official Title  ICMJE A Stepped-wedge Cluster Randomized Trial to Assess the Effectiveness of the Use of the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac
Brief Summary

This is a stepped-wedge cluster randomized trial to assess effectiveness of Sinovac's Adsorbed COVID-19 (Inactivated) vaccine. Residents in the urban area of a municipality are eligible to participate. The city was divided in clusters and those cluster were grouped to determine the offer of vaccination in four steps. The vaccine will be offered to adults (18 years old and above) according to the location of their homes in a cluster. The vaccine schedule is two doses with four-weeks interval. Baseline samples to determine previous immunity will be collected before vaccination.

Cases of COVID-19 reported in the city will be recorded according to the WHO clinical progression scale. Comparison of periods before and after vaccination and relation to immunization coverage will be considered for the assessment of effectiveness in the clusters and groups of clusters.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Groups of cluster are allocated to offer vaccination in a stepped-wedge mode.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac
Study Arms  ICMJE
  • Experimental: First group of clusters
    Adsorbed COVID-19 (Inactivated) vaccine offered in the first week of study The vaccine is administrated in two doses with a four-weeks interval
    Intervention: Biological: Adsorbed COVID-19 (Inactivated) Vaccine
  • Experimental: Second group of clusters
    Adsorbed COVID-19 (Inactivated) vaccine offered in the second week of study The vaccine is administrated in two doses with a four-weeks interval
    Intervention: Biological: Adsorbed COVID-19 (Inactivated) Vaccine
  • Experimental: Third group of clusters
    Adsorbed COVID-19 (Inactivated) vaccine offered in the third week of study The vaccine is administrated in two doses with a four-weeks interval
    Intervention: Biological: Adsorbed COVID-19 (Inactivated) Vaccine
  • Experimental: Fourth group of clusters
    Adsorbed COVID-19 (Inactivated) vaccine offered in the fourth week of study The vaccine is administrated in two doses with a four-weeks interval
    Intervention: Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 6, 2021)
27711
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
30000
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults 18 years of age or older;
  2. Resident in the study area;
  3. Show voluntary intention to participate in the study, documented by the informed consent form signed by participant.

Exclusion Criteria:

  1. For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination;
  2. Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease, according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
  3. Diseases with impaired immune system including: neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not controlled according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
  4. Behavioral, cognitive or psychiatric disease that, in the opinion of the principal investigator or his or her representative physician, affects the participant's ability to understand and cooperate with all study protocol requirements;
  5. Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history;
  6. History of severe allergic reactions or anaphylaxis to the study vaccine or to components thereof;
  7. History of asplenia;
  8. Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment;
  9. Previous participation in a study to evaluate a COVID-19 vaccine or prior exposure to a COVID-19 vaccine;
  10. Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study for planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others.
  11. Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant;
  12. Received blood products (transfusions or immunoglobulins) within the three months prior to enrollment in the study, or planned administration of blood products or immunoglobulins within the two years following enrollment in the study;
  13. Suspected or confirmed fever within the 72 hours prior to vaccination or axillary temperature greater than 37.8 °C* on the day of vaccination (enrollment may be postponed until participant has gone 72 hours without fever);
  14. Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
  15. Received live attenuated virus vaccine or inactivated vaccine within the 28 days or 14 days, respectively, prior to enrollment in the study, or immunization planned within the 28 days after enrollment in the study;
  16. History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
  17. Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04747821
Other Study ID Numbers  ICMJE COV-04-IB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Butantan Institute
Study Sponsor  ICMJE Butantan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ricardo Palacios, MD, PhD Butantan Institute
PRS Account Butantan Institute
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP