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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747821
Recruitment Status : Unknown
Verified April 2021 by Butantan Institute.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Butantan Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Biological: Adsorbed COVID-19 (Inactivated) Vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27711 participants
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
Official Title: A Stepped-wedge Cluster Randomized Trial to Assess the Effectiveness of the Use of the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac
Actual Study Start Date : February 7, 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac
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
 Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac
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
 Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac
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
 Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747821


Locations
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Brazil
Hospital Estadual de Serrana
Serrana, SP, Brazil, 14150-000
Sponsors and Collaborators
Butantan Institute
Investigators
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Study Director: Ricardo Palacios, MD, PhD Butantan Institute
More Information
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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT04747821    
Other Study ID Numbers: COV-04-IB
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Butantan Institute:
COVID-19 Vaccines
Vaccines, Inactivated
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases