Tunis Military Hospital Staff Vaccinated Against Covid 19IACOVVNCT04924855
Immunity After COVID-19 Vaccination
An observational study of Tunis Military Hospital Staff Vaccinated Against Covid 19, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tunis Military Hospital Staff Vaccinated Against Covid 19
- What is being tested?
- Blood sampling (4 per year)
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2021to 1 Aug 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: military health personnel vaccinated at tunis military hospital
Who may be able to join
- 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 -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
HMPIT vaccination committee
Tunis, Please Select..., 1008
Nejla stambouli, 55104235, nejlastam@gmail.com
About this study
Official title: Estimation of Dynamics of Humoral Immunity in COVID-19 Vaccined Health Care Workers
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
Read the detailed description
Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:
G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology <0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)
- Being tested
- Blood sampling (4 per year)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling (4 per year)Other
Blood sampling (4 per year)
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine effectiveness
Vaccine effectiveness as measured by the number of positive PCRs in one year
Measured: 1 year
Vaccine effectiveness
antibody kinetics
Measured: 1 year
Secondary outcomes (1)
the tolerance of the vaccine
post-vaccination adverse event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study startJul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tunis Military Hospital Staff Vaccinated Against Covid 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924855
- Sponsor's protocol ID
- UR17DN05-3
- Acronym
- IACOVV
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Dynamics of Humoral Immunity in COVID-19 Vaccined Health Care Workers
- ClinicalTrials.gov ID
- NCT04924855
- Acronym / sponsor ID
- IACOVV / UR17DN05-3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:
G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology <0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- military health personnel vaccinated at tunis military hospital
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling (4 per year)Blood sampling (4 per year) | Other | – |
Primary outcome
Vaccine effectiveness
Time frame: 1 year
Vaccine effectiveness as measured by the number of positive PCRs in one year
Vaccine effectiveness
Time frame: 1 year
antibody kinetics
1 secondary outcome
the tolerance of the vaccine
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tunis Military Hospital Staff Vaccinated Against Covid 19, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine effectiveness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.