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

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

Tracking Information

• First Submitted Date: March 5, 2021
• First Posted Date: March 9, 2021
• Last Update Posted Date: July 26, 2021
• Actual Study Start Date: March 18, 2021
• Actual Primary Completion Date: July 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2021)

• 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
• 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
• 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
• 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
• Incidence density of clinical cases virologically confirmed as COVID-19 [ Time Frame: After first dose, up to 12 months. ]
• Mortality confirmed as COVID-19 [ Time Frame: After first dose, up to 12 months. ]
  Incidence density of deaths confirmed as COVID-19
• Incidence density of hospitalizations for any cause [ Time Frame: After first dose, up to 12 months. ]
• Mortality from any cause [ Time Frame: After first dose, up to 12 months. ]
  Density of mortality from any cause
• 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
• 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
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity
• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Quasi-experimental study

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Covid19

Intervention

Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine

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

Other Name: CoronaVac

Study Arms

• 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
  Intervention: Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 22, 2021): 6233
• Original Estimated Enrollment (submitted: March 8, 2021): 10156
• Estimated Study Completion Date: March 2022
• Actual Primary Completion Date: July 5, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04789356
• Other Study ID Numbers: CAAE: 44076721.5.0000.0005
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Original Study Sponsor: Same as current
• Collaborators: Butantan Institute

Investigators

• Principal Investigator: Marcus Lacerda, MD; Fundação de Medicina Tropical Heitor Vieira Dourado

• PRS Account: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Verification Date: July 2021