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

22 juli 2021 bijgewerkt door: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

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)

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

6233

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
    • Amazonas
      • Manaus, Amazonas, Brazilië, 69050-010
        • Escola Normal Superior - Universidade do Estado do Amazonas

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 49 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Biologisch: Adsorbed SARS-CoV-2 (inactivated) vaccine
600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.
Andere namen:
  • CoronaVac
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence density of moderate and severe clinical cases of COVID-19
Tijdsspanne: 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.
2 weeks after the second vaccine dose

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
Tijdsspanne: 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
After first dose, up to 12 months.
Incidence density of moderate and severe clinical cases of COVID-19 after second dose
Tijdsspanne: 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
After second dose, up to 12 months.
Incidence density of severe clinical cases of COVID-19 after second dose
Tijdsspanne: 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
After second dose, up to 12 months.
Median of clinical progression scores between moderate and severe cases
Tijdsspanne: After first dose, up to 12 months.
Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups
After first dose, up to 12 months.
Incidence density of clinical cases virologically confirmed as COVID-19
Tijdsspanne: After first dose, up to 12 months.
After first dose, up to 12 months.
Mortality confirmed as COVID-19
Tijdsspanne: After first dose, up to 12 months.
Incidence density of deaths confirmed as COVID-19
After first dose, up to 12 months.
Incidence density of hospitalizations for any cause
Tijdsspanne: After first dose, up to 12 months.
After first dose, up to 12 months.
Mortality from any cause
Tijdsspanne: After first dose, up to 12 months.
Density of mortality from any cause
After first dose, up to 12 months.
Adverse events
Tijdsspanne: 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
Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
Humoral and cell-mediated immune response
Tijdsspanne: 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
Before each vaccine dose and every 3 months, up to 12 months of follow-up.
Detection of antibodies against SARS-CoV-2 in samples
Tijdsspanne: Before each vaccine dose and every 3 months, up to 12 months of follow-up
Before each vaccine dose and every 3 months, up to 12 months of follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Medewerkers

Butantan Institute

Onderzoekers

  • Hoofdonderzoeker: Marcus Lacerda, MD, Fundação de Medicina Tropical Heitor Vieira Dourado

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 maart 2021

Primaire voltooiing (Werkelijk)

5 juli 2021

Studie voltooiing (Verwacht)

1 maart 2022

Studieregistratiedata

Eerst ingediend

5 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

8 maart 2021

Eerst geplaatst (Werkelijk)

9 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CAAE: 44076721.5.0000.0005

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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