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Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)

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: NCT04789356
Recruitment Status : Active, not recruiting
First Posted : March 9, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Butantan Institute
Information provided by (Responsible Party):
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study Description
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Brief Summary:
This is a quasi-experimental study with risk-based allocation. Public security and education professionals from the state government will be included. In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19. Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days). Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project. If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after). All participants will be followed up for 12 months from inclusion in the study. Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6233 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Quasi-experimental study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)
Actual Study Start Date : March 18, 2021
Actual Primary Completion Date : July 5, 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High-risk individuals (with comorbidities)
Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine
 Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine
600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.
Other Name: CoronaVac
No Intervention: Low-risk individuals (without comorbidities)
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence density of moderate and severe clinical cases of COVID-19 [ Time Frame: 2 weeks after the second vaccine dose ]
    Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.


Secondary Outcome Measures :
  1. Incidence density of moderate and severe clinical cases of COVID-19 after first dose [ Time Frame: After first dose, up to 12 months. ]
    Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose

  2. Incidence density of moderate and severe clinical cases of COVID-19 after second dose [ Time Frame: After second dose, up to 12 months. ]
    Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose

  3. Incidence density of severe clinical cases of COVID-19 after second dose [ Time Frame: After second dose, up to 12 months. ]
    Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose

  4. Median of clinical progression scores between moderate and severe cases [ Time Frame: After first dose, up to 12 months. ]
    Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups

  5. Incidence density of clinical cases virologically confirmed as COVID-19 [ Time Frame: After first dose, up to 12 months. ]
  6. Mortality confirmed as COVID-19 [ Time Frame: After first dose, up to 12 months. ]
    Incidence density of deaths confirmed as COVID-19

  7. Incidence density of hospitalizations for any cause [ Time Frame: After first dose, up to 12 months. ]
  8. Mortality from any cause [ Time Frame: After first dose, up to 12 months. ]
    Density of mortality from any cause

  9. Adverse events [ Time Frame: Up to 7 days after each dose of the vaccine (Day 7 and Day 35) ]
    Frequency of adverse events associated with the need for medical care

  10. Humoral and cell-mediated immune response [ Time Frame: Before each vaccine dose and every 3 months, up to 12 months of follow-up. ]
    Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants

  11. Detection of antibodies against SARS-CoV-2 in samples [ Time Frame: Before each vaccine dose and every 3 months, up to 12 months of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 49 years
  • Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.

Exclusion Criteria:

  • Prior vaccination for COVID-19;
  • Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
  • History of severe allergic reaction or anaphylaxis to study vaccine components;
  • Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
  • Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
  • Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
  • Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
  • Pregnancy or breastfeeding.
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): NCT04789356


Locations
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Brazil
Escola Normal Superior - Universidade do Estado do Amazonas
Manaus, Amazonas, Brazil, 69050-010
Sponsors and Collaborators
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Butantan Institute
Investigators
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Principal Investigator: Marcus Lacerda, MD Fundação de Medicina Tropical Heitor Vieira Dourado
More Information
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Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
ClinicalTrials.gov Identifier: NCT04789356    
Other Study ID Numbers: CAAE: 44076721.5.0000.0005
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado:
SARS-CoV-2
Brazil
Covid-19
Vaccine
 Sinovac
CoronaVac
Vaccine efficacy
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases