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

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Adsorbed SARS-CoV-2 (inactivated) vaccine

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, Brazil, Covid-19, Vaccine, Sinovac, CoronaVac, Vaccine efficacy

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Escola Normal Superior - Universidade do Estado do Amazonas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

High-risk individuals (with comorbidities)

Low-risk individuals (without comorbidities)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence density of moderate and severe clinical cases of COVID-19

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

Incidence density of moderate and severe clinical cases of COVID-19 after first dose

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

Incidence density of moderate and severe clinical cases of COVID-19 after second dose

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

Incidence density of severe clinical cases of COVID-19 after second dose

Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose

Median of clinical progression scores between moderate and severe cases

Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups

Incidence density of clinical cases virologically confirmed as COVID-19

Mortality confirmed as COVID-19

Incidence density of deaths confirmed as COVID-19

Incidence density of hospitalizations for any cause

Mortality from any cause

Density of mortality from any cause

Adverse events

Frequency of adverse events associated with the need for medical care

Humoral and cell-mediated immune response

Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants

Detection of antibodies against SARS-CoV-2 in samples

Full Information

NCT ID

NCT04789356

First Posted

March 5, 2021

Last Updated

July 22, 2021

Sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Collaborators

Butantan Institute

1. Study Identification

Unique Protocol Identification Number

NCT04789356

Brief Title

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

Acronym

COVACMANAUS

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 18, 2021 (Actual)

Primary Completion Date

July 5, 2021 (Actual)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Collaborators

Butantan Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

SARS-CoV-2, Brazil, Covid-19, Vaccine, Sinovac, CoronaVac, Vaccine efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Quasi-experimental study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6233 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-risk individuals (with comorbidities)

Arm Type

Active Comparator

Arm Description

Arm Title

Low-risk individuals (without comorbidities)

Arm Type

No Intervention

Arm Description

Intervention Type

Biological

Intervention Name(s)

Adsorbed SARS-CoV-2 (inactivated) vaccine

Other Intervention Name(s)

CoronaVac

Intervention Description

600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Primary Outcome Measure Information:

Title

Incidence density of moderate and severe clinical cases of COVID-19

Description

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.

Time Frame

2 weeks after the second vaccine dose

Secondary Outcome Measure Information:

Title

Incidence density of moderate and severe clinical cases of COVID-19 after first dose

Description

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

Time Frame

After first dose, up to 12 months.

Title

Incidence density of moderate and severe clinical cases of COVID-19 after second dose

Description

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

Time Frame

After second dose, up to 12 months.

Title

Incidence density of severe clinical cases of COVID-19 after second dose

Description

Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose

Time Frame

After second dose, up to 12 months.

Title

Median of clinical progression scores between moderate and severe cases

Description

Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups

Time Frame

After first dose, up to 12 months.

Title

Incidence density of clinical cases virologically confirmed as COVID-19

Time Frame

After first dose, up to 12 months.

Title

Mortality confirmed as COVID-19

Description

Incidence density of deaths confirmed as COVID-19

Time Frame

After first dose, up to 12 months.

Title

Incidence density of hospitalizations for any cause

Time Frame

After first dose, up to 12 months.

Title

Mortality from any cause

Description

Density of mortality from any cause

Time Frame

After first dose, up to 12 months.

Title

Adverse events

Description

Frequency of adverse events associated with the need for medical care

Time Frame

Up to 7 days after each dose of the vaccine (Day 7 and Day 35)

Title

Humoral and cell-mediated immune response

Description

Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants

Time Frame

Before each vaccine dose and every 3 months, up to 12 months of follow-up.

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcus Lacerda, MD

Organizational Affiliation

Fundação de Medicina Tropical Heitor Vieira Dourado

Official's Role

Principal Investigator

Facility Information:

Facility Name

Escola Normal Superior - Universidade do Estado do Amazonas

City

Manaus

State/Province

Amazonas

ZIP/Postal Code

69050-010

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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