NCT04924855

Brief Summary

The purpose of the research is to evaluate kinetic after vaccination to the COVID-19 coronavirus by measurements of specific and neutralizant antibodies for spike antigenic sequences . This work will allow us to follow the efficacy and tolerance of the vaccine over a year, to evaluate the antibody profile, their kinetics, the fraction of neutralising antibodies and will also allow us to understand the attitudes to be taken to ensure the best protection for our staff

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 10, 2021

Last Update Submit

June 10, 2021

Conditions

Tunis Military Hospital Staff Vaccinated Against Covid 19

Outcome Measures

Primary Outcomes (2)

  • Vaccine effectiveness

    Vaccine effectiveness as measured by the number of positive PCRs in one year

    1 year

  • Vaccine effectiveness

    antibody kinetics

    1 year

Secondary Outcomes (1)

  • the tolerance of the vaccine

    1 year

Interventions

Blood sampling (4 per year)OTHER

Blood sampling (4 per year)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

military health personnel vaccinated at tunis military hospital

You may qualify if:

  • RB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination.
  • Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination.
  • Sampling Frequency and timing: Up to 8 total samples in 12 months -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMPIT vaccination committee

Tunis, Please Select..., 1008, Tunisia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling (4 per year)

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 14, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)