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

Covid19 Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04789356
• Other study ID #: CAAE: 44076721.5.0000.0005
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 18, 2021
• Est. completion date: March 2022

Study information

• Verified date: July 2021
• Source: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6233
• Est. completion date: March 2022
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• Adsorbed SARS-CoV-2 (inactivated) vaccine
600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Locations

Country	Name	City	State
Brazil	Escola Normal Superior - Universidade do Estado do Amazonas	Manaus	Amazonas

Sponsors (2)

Lead Sponsor	Collaborator
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado	Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after the second vaccine dose
Secondary	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	After first dose, up to 12 months.
Secondary	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	After second dose, up to 12 months.
Secondary	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	After second dose, up to 12 months.
Secondary	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	After first dose, up to 12 months.
Secondary	Incidence density of clinical cases virologically confirmed as COVID-19		After first dose, up to 12 months.
Secondary	Mortality confirmed as COVID-19	Incidence density of deaths confirmed as COVID-19	After first dose, up to 12 months.
Secondary	Incidence density of hospitalizations for any cause		After first dose, up to 12 months.
Secondary	Mortality from any cause	Density of mortality from any cause	After first dose, up to 12 months.
Secondary	Adverse events	Frequency of adverse events associated with the need for medical care	Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
Secondary	Humoral and cell-mediated immune response	Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants	Before each vaccine dose and every 3 months, up to 12 months of follow-up.
Secondary	Detection of antibodies against SARS-CoV-2 in samples		Before each vaccine dose and every 3 months, up to 12 months of follow-up