- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05104385
Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences (HU-CoVaCS)
Hacettepe Health Cohort: A Prospective Follow-up of the General Health Status and Effectiveness, Durability and Adverse Effects of COVID-19 Vaccine Among Students of Medical and Dental Schools
Study Overview
Status
Detailed Description
The study was planned, and ethical approval procedures were initiated in late January, 2021. However, serial official approval processes delayed the initiation of the study beyond the pre-planned initiation date (late in March 2021, to catch the 28th day after the second dose of CoronaVac vaccine). Thus, the study plan was revised, and so were the approval processes.
The planned prospective cohort study started its recruitment process in June, with the first enrollment on June 21, 2021. The study is an open cohort; vaccination times vary, some students participated in the first visit, but have/can leave the study before May 2023 (the planned closure time for testing); some students did not participate in the first visit (in June-July 2021), yet preferred to be involved in the study bythe time of the second visit (October 2021) and so.
Participants are being recruited from students of medical school (grades 4,5, and 6) and dental school (grade 4 and %), and are involved in the study for all/some of the procedures offered. The study aimed to:
- Investigate the sociodemographic characteristics, health status, life habits, quality of life (via validated indices), COVID-19 status, vaccination status for SARS-CoV-2, use of non-pharmaceutical preventive measures against COVID-19. These will be accomplished through online, depersonalized, self-completed standardized questionnaire and use of validated scales.;
- Complete anthropometric measures and physical examination at each visit;
- Check blood levels for complete blood count, renal function tests, liver enzymes, D-dimer, vitamin D, HbA1c levels, and lipid profile;
- Check vaccine-induced immunity using quantitative, Anti-SARS-CoV-2 Receptor Binding Domain kit (Abbott Laboratories) at enrolment and each subsequent visits;
- Evaluate the durability of vaccine-induced immunity, as measured by antibody levels periodically (at 3rd, 6th, 12th and 24th month after full immunization following full vaccination, i.e. 2 doses plus 28 days);
- The cohort will be followed up to 24 months (through September 2023) for detecting COVID-19 infection and/or related hospitalization, intensive care unit (ICU)-admission or death; also, to study the potential association with personal risk factors and/or vaccine-induced immunity;
- A nested, test-negative case-control study is integrated into the the cohort, such that each time a new COVID-19 case is identified (with a PCR-positivity), two gender and school/grade matched controls will be invited for PCR testing. Blood will be drawn from PCR test negative controls at the day (or within 1 day later) of the PCR-positivity of the case detected. This nested case-(test-negative) control design will enable to study the association between infection and current Anti-Spike1 RBD antibody levels, controlling for personal risk factors;
- Given the considerable amount of asymptomatic infections among vaccinated individuals, 150 participants will be selected from among volunteers for 6 consecutive PCR-testing, with 15 days intervals between each testing.
Three study designs will be used to reach study objectives; namely, a large prospective cohort (for evaluating changes in general health status and neutralizing antibody levels, as measured by SARS-CoV-2-RBD Abs); a subcohort for periodical PCR testing to detect asymptomatic infection rates;
Over the course of the planned study, Pfizer-Biontech (R) m-RNA vaccination has been introduced for mass vaccination, as 2 doses, 28 days apart. Also, the Ministry of Health promoted a third dose of COVID-19 vaccination for health personnel in particular, due to rapidly decreasing immunity for COVID-19 among 2-dose CoronaVac vaccinated individuals. This change in mass vaccination introduced variation in our exposure status. Accordingly, the objectives of the study extended to calculation and comparison of the incidence-rates of COVID-19 infection and related complications among those vaccinated with either of the 2 vaccines (namely, CoronaVac and Biontech), controlling for the first doses and boosters, including mix-and-matches.
The four visits of the main cohort was completed as of July 7, 2023 (as planned). Preliminary findings have been published in a Turkish peer-reviewed medical journal. Due to administrative issues, periodic PCR-based asymptomatic case detection was postponed- will be resumed in Fall 2023 (if case numbers increase). The nested case-control sub-study will continue through November 1, 2023, as PCR-confirmed cases appear. So far, we have a total of 194 cases since the initiation of the cohort; 154 of these were detected by the cohort team, others were detected outside the cohort facility, but all were confirmed (upon students' approval) through personal electronic health records. The study is anticipated to finish by december 7, 2023. The unexpected 3 months of delay at initiation of the study (due to the time lag for the ethical approval process at the Ministry of Health) led to an expansion in data analysis and final reporting of the study (registered as December 7, 2023, by the University Scientific Research Unit, which is the sole funder of the study.)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University, Sıhhiye Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Study population is a sample of senior students of Hacettepe University medical and dental students, who actively work in Hacettepe hospitals during COVID-19 pandemic and, thus, have the potential for contacting COVID-19 infected individuals.
The study team will approach all eligible students. Yet, participation in the study is totally voluntary, thus, the final sample is not expected to be a random sample of all eligibles.
Study participants will be motivated to be in the study through graduation or study completion date, which ever come earlier.
Description
Inclusion Criteria:
1) students of the medical school (grades 4,5 and 6) in 2021 Spring semester 2 )students of the dental school (grades 4 and 5) in 2021 Spring semester 3) new comers of grade 4 of medical and dental school in 2021 Fall semester 4) those providing informed consent to participate in the study.
Exclusion Criteria:
None.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hacettepe University Health Cohort- Students of Health Sciences
Students of medical school (grades 4,5, and 6) in 2021 Spring Students of dental school (grades 4 and 5) in 2021 Spring New comers of grade 4 in both medical and dental school will be recruited early in October 2021. There is no intervention. Vaccinations for COVID-19 have been provided by the Turkish Ministry of Health, in a pre-planned schedule. The study will follow students after vaccination, regardless of the type and dose administered. |
Based on the Turkish Ministry of Health regulations, any research protocol involving use of any drug/vaccine needs to be presented in a clinical trial format, and is presented to the clinical research ethical boards accordingly.
Otherwise, the study has no intervention (to the exposure status) involved.
Selection, administration, number of doses applied and the period between vaccine doses are beyond the capacity the study team.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccine-induced immunity (status and durability) against SARS-CoV-2
Time Frame: 21 June 2021-7 July 2023
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Anti-SARS-CoV-2 Spike 1 RBD antibodies are measured as a surrogate measure for vaccine-induced immunity
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21 June 2021-7 July 2023
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General health status (physical, mental, social)
Time Frame: 21 June 2021-7 July 2023
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Status and change in the self-reported morbidity and validated scales-based mental health status and quality of life will be followed over time.
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21 June 2021-7 July 2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 infection and related health complications
Time Frame: 21 June 2021-7 December 2023
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Incident cases of PCR-test positive COVID-19 cases, related hospitalization, intensive care unit (ICU) stay and death
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21 June 2021-7 December 2023
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Banu Cakir, Hacettepe University, Division of Epidemiology (Chair)
Publications and helpful links
General Publications
- E. Karadogan Et Al. ,
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCP-2021-19467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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