Covid19NCT04887246
Monitoring the Effectiveness and Safety of COVID-19 Vaccines at National University of Colombia
An observational study of Covid19 and SARS-CoV2 Infection, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV2 Infection
- What is being tested?
- COVID-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 4,078 participants
- Where
- 1 siteColombia
- Study dates
- 15 Mar 2021to 15 Dec 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort of the university population (UNISALUD affiliated and beneficiary personnel, students and their families),
Who may be able to join
- All UN contractors (administrative, teachers and pensioners) who belong to the different UN headquarters and agree to participate in the study
Who cannot join
- Contractors not not affiliated to UNISALUD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring the Effectiveness and Safety of Covid-19 Vaccines in the University Population-National University of Colombia
There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. It is a project that is considered institutional importance and is part of the actions that the National University of Colombia has proposed to the national government to accompany the national vaccination program.
The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological characterization of the vaccinated population, including the report of adverse events occurring after the vaccination process, the behavior of the population after the administration of the vaccine, monitoring serological outcomes, identification of medication errors and therapeutic failure. Three stages are proposed in which the population affiliated to UNISALUD is gradually included, then the beneficiaries and later the student community and their families.
The scope of the attached protocol includes Stage I, which corresponds to teachers and administrative staff (active and retired) linked to UNISALUD.
Read the detailed description
OBJECTIVE: To evaluate the clinical outcomes and adverse events associated with immunization (ESAVI) of vaccines against COVID-19 in the cohort of the university community, affiliates and beneficiaries of UNISALUD and students of the National University of Colombia.
METHODOLOGY: Descriptive longitudinal, prospective and observational study. Follow-up to a cohort without a control group. Modular multi-center stage study. The development of the research is proposed through a modular, multicenter and staged study. For the first phase, all employees of the National University of Colombia (active and retired) who agree to participate in the study will be monitored. The second phase includes monitoring the beneficiaries of UNISALUD affiliates and the third phase includes students and their families. For the calculation of the sample size in phase III, it will be carried out by applying formulas for descriptive studies.
Follow-up Time: It is estimated to be one year from the date of the first dose of the vaccine. A second phase is expected to follow up the outcomes for another additional year.
Data collection: It will begin with the presentation of the informed consent for the presentation of the study. Subsequently, a periodic follow-up will be carried out via telephone or email to identify and complete the established sociodemographic, cultural, clinical and pharmacological variables.
Serological Follow-up: The humoral immune response and its duration will be analyzed through serological tests with a blood sample to a sample of the study population. Serological follow-up will be carried out in 3 moments: prior to vaccination, after the first dose of the vaccine, and at the end of the study. The collected samples will be taken to the Laboratory of the Faculty of Medicine of the National University of Colombia for their separation. Antibody analysis will be done by chemiluminescence using the Advia Centaur COV2 platform from Siemens (3).
ETHICAL ASPECTS: This research is considered a research with minimal risk (Resolution No. 008430 of October 4, 1993 in article 11 of Colombia's Ministry of Healt ). When handling very sensitive information, the informed consent of the user and / or his manager will be filled out, prior to the start of the application of the data collection instrument, and the collection of blood samples for serological monitoring.
Access to the clinical and pharmacological information of the participants affiliated and beneficiaries of UNISALUD will be required, which will be provided by the same entity, as well as the databases adjusted to the vaccination phases in Colombia. In the case of students, basic contact information and financial situation will be needed, which will be reported by the University Welfare Directorate.
The treatment of information and data collected in accordance with Law 1266 of 2008 "Habeas Data" and subject to acceptance by the participants through informed consent.
This study protocol has the endorsement of the ethics committee of the Faculty of Sciences in a meeting held on March 1, 2021 (Minutes 02-2021).
- Conditions
- Covid19, SARS-CoV2 Infection
- Being tested
- COVID-19 vaccines
- Keywords
- Covid-19, Vaccines, Safety and Effectiveness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinesBiological
COVID-19 vaccines available at Colombia
| Study group | Role | What they receive |
|---|---|---|
| UNISALUD population | Refers to all affiliated members or beneficiaries of the UNISALUD entity, who got any of tthe COVID-19 vaccines available in Colombia Receives: Biological: COVID-19 vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Reports of Adverse Events Associated with COVID-19 Vaccines
Measured: One year
COVID-19 diagnosis
People who after the vaccination process are diagnosed with COVID-19
Measured: One year
Secondary outcomes (1)
Serological response
Serological analysis to identify humoral immune response and duration
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start15 Mar 2021
- Primary completion15 Apr 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887246
- Sponsor's protocol ID
- 52932
- Status last verified
- Jul 2024
- First submitted
- 10 May 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Effectiveness and Safety of Covid-19 Vaccines in the University Population-National University of Colombia
- ClinicalTrials.gov ID
- NCT04887246
- Acronym / sponsor ID
- 52932
- Conditions
- Covid19, SARS-CoV2 Infection
- Keywords
- Covid-19, Vaccines, Safety and Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,078 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 14 May 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.
There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. It is a project that is considered institutional importance and is part of the actions that the National University of Colombia has proposed to the national government to accompany the national vaccination program.
The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological characterization of the vaccinated population, including the report of adverse events occurring after the vaccination process, the behavior of the population after the administration of the vaccine, monitoring serological outcomes, identification of medication errors and therapeutic failure. Three stages are proposed in which the population affiliated to UNISALUD is gradually included, then the beneficiaries and later the student community and their families.
The scope of the attached protocol includes Stage I, which corresponds to teachers and administrative staff (active and retired) linked to UNISALUD.
Detailed description
OBJECTIVE: To evaluate the clinical outcomes and adverse events associated with immunization (ESAVI) of vaccines against COVID-19 in the cohort of the university community, affiliates and beneficiaries of UNISALUD and students of the National University of Colombia.
METHODOLOGY: Descriptive longitudinal, prospective and observational study. Follow-up to a cohort without a control group. Modular multi-center stage study. The development of the research is proposed through a modular, multicenter and staged study. For the first phase, all employees of the National University of Colombia (active and retired) who agree to participate in the study will be monitored. The second phase includes monitoring the beneficiaries of UNISALUD affiliates and the third phase includes students and their families. For the calculation of the sample size in phase III, it will be carried out by applying formulas for descriptive studies.
Follow-up Time: It is estimated to be one year from the date of the first dose of the vaccine. A second phase is expected to follow up the outcomes for another additional year.
Data collection: It will begin with the presentation of the informed consent for the presentation of the study. Subsequently, a periodic follow-up will be carried out via telephone or email to identify and complete the established sociodemographic, cultural, clinical and pharmacological variables.
Serological Follow-up: The humoral immune response and its duration will be analyzed through serological tests with a blood sample to a sample of the study population. Serological follow-up will be carried out in 3 moments: prior to vaccination, after the first dose of the vaccine, and at the end of the study. The collected samples will be taken to the Laboratory of the Faculty of Medicine of the National University of Colombia for their separation. Antibody analysis will be done by chemiluminescence using the Advia Centaur COV2 platform from Siemens (3).
ETHICAL ASPECTS: This research is considered a research with minimal risk (Resolution No. 008430 of October 4, 1993 in article 11 of Colombia's Ministry of Healt ). When handling very sensitive information, the informed consent of the user and / or his manager will be filled out, prior to the start of the application of the data collection instrument, and the collection of blood samples for serological monitoring.
Access to the clinical and pharmacological information of the participants affiliated and beneficiaries of UNISALUD will be required, which will be provided by the same entity, as well as the databases adjusted to the vaccination phases in Colombia. In the case of students, basic contact information and financial situation will be needed, which will be reported by the University Welfare Directorate.
The treatment of information and data collected in accordance with Law 1266 of 2008 "Habeas Data" and subject to acceptance by the participants through informed consent.
This study protocol has the endorsement of the ethics committee of the Faculty of Sciences in a meeting held on March 1, 2021 (Minutes 02-2021).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UNISALUD population | – | Biological: COVID-19 vaccinesRefers to all affiliated members or beneficiaries of the UNISALUD entity, who got any of tthe COVID-19 vaccines available in Colombia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort of the university population (UNISALUD affiliated and beneficiary personnel, students and their families),
Key inclusion criteria (1 listed)
- All UN contractors (administrative, teachers and pensioners) who belong to the different UN headquarters and agree to participate in the study
Key exclusion criteria (1 listed)
- Contractors not not affiliated to UNISALUD
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 |
|---|---|---|
| COVID-19 vaccinesCOVID-19 vaccines available at Colombia | Biological | UNISALUD population |
Primary outcome
Adverse events
Time frame: One year
Reports of Adverse Events Associated with COVID-19 Vaccines
COVID-19 diagnosis
Time frame: One year
People who after the vaccination process are diagnosed with COVID-19
1 secondary outcome
Serological response
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and SARS-CoV2 Infection, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 1 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: finished, as of the sponsor's last update on 11 Jul 2024. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: One 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 11 Jul 2024.