Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

22 juillet 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

6233

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 49 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Biologique: Adsorbed SARS-CoV-2 (inactivated) vaccine
600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.
Autres noms:
  • CoronaVac
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence density of moderate and severe clinical cases of COVID-19
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence density of moderate and severe clinical cases of COVID-19 after first dose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: After first dose, up to 12 months.
After first dose, up to 12 months.
Mortality confirmed as COVID-19
Délai: 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
Délai: After first dose, up to 12 months.
After first dose, up to 12 months.
Mortality from any cause
Délai: After first dose, up to 12 months.
Density of mortality from any cause
After first dose, up to 12 months.
Adverse events
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Collaborateurs

Butantan Institute

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 mars 2021

Achèvement primaire (Réel)

5 juillet 2021

Achèvement de l'étude (Anticipé)

1 mars 2022

Dates d'inscription aux études

Première soumission

5 mars 2021

Première soumission répondant aux critères de contrôle qualité

8 mars 2021

Première publication (Réel)

9 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CAAE: 44076721.5.0000.0005

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Covid19

Essais cliniques sur Adsorbed SARS-CoV-2 (inactivated) vaccine

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Cambodia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner