- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04789356
Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)
22. juli 2021 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6233
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Amazonas
-
Manaus, Amazonas, Brasilien, 69050-010
- Escola Normal Superior - Universidade do Estado do Amazonas
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 49 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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
|
600 SU/dose; Two doses separated by 28 days (± 7 days).
Intramuscular (deltoid) administration.
Andre navne:
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: After first dose, up to 12 months.
|
After first dose, up to 12 months.
|
|
Mortality confirmed as COVID-19
Tidsramme: 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
Tidsramme: After first dose, up to 12 months.
|
After first dose, up to 12 months.
|
|
Mortality from any cause
Tidsramme: After first dose, up to 12 months.
|
Density of mortality from any cause
|
After first dose, up to 12 months.
|
Adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marcus Lacerda, MD, Fundação de Medicina Tropical Heitor Vieira Dourado
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. marts 2021
Primær færdiggørelse (Faktiske)
5. juli 2021
Studieafslutning (Forventet)
1. marts 2022
Datoer for studieregistrering
Først indsendt
5. marts 2021
Først indsendt, der opfyldte QC-kriterier
8. marts 2021
Først opslået (Faktiske)
9. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAAE: 44076721.5.0000.0005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Covid19
-
Anavasi DiagnosticsIkke rekrutterer endnu
-
Ain Shams UniversityRekruttering
-
Israel Institute for Biological Research (IIBR)Afsluttet
-
Colgate PalmoliveAfsluttet
-
Christian von BuchwaldAfsluttet
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdAktiv, ikke rekrutterende
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichTilmelding efter invitation
-
Alexandria UniversityAfsluttet
-
Henry Ford Health SystemAfsluttet
Kliniske forsøg med Adsorbed SARS-CoV-2 (inactivated) vaccine
-
Istituto Clinico HumanitasRekruttering
-
Kern Medical CenterAfsluttetCOVID-19 | Sociale determinanter for sundhed | Penetrerende skadeForenede Stater
-
Kern Medical CenterAfsluttetCOVID-19 | Postoperative komplikationer | Kirurgiske resultaterForenede Stater