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
1 other identifier
observational
1,223
1 country
1
Brief Summary
The first COVID-19 case in Turkey was reported on March 11, 2000. National COVID-19 mass vaccination was initiated on Jan 13, 202, with two doses of CoronaVac (R) inactivated vaccine (of Sinovac), 28 days apart. The health personnel were prioritized in the mass vaccination, given their high rates of exposure and fatality. National COVID-19 statistics have been limited to those announced in the media; data breakdown by gender, age, vaccine type and status etc. is not provided, nor is the association between non-pharmaceutical preventive measures (NPPM) and infection rates. Well-planned, longitudinal, detailed studies with laboratory support are clearly warranted. Hacettepe University is a leading institution in Turkey, with its large health sciences campus. Students of medical school (grades 4, 5, and 6) and dental school (grades 4 and 5) have been actively providing patient care in HU Hospitals, and more than 10% of medical interns had been reportedly diagnosed as COVID-19 cases prior to vaccination activities, despite (reportedly) strict non-pharmaceutical public preventive measures (NPPM) use inside/outside the occupational settings. A two-year prospective cohort study was planned for periodic evaluation of students' general health status and COVID-19 risk/exposure/infection, for timely referrals and quarantine/isolation, as needed. Anti- SARS-CoV-2-RBS antibodies will be measured periodically after vaccination, together with evaluation of potential adverse effects, presence and durability of vaccine-induced immunity. Comparison of antibody levels were planned for incident COVID-19 cases and two test-negative controls of the same gender, attending the same grade and faculty. A subcohort will be followed for aymptomatic infection risk. Institutional ethical approvals were obtained, as required. A step-wise informed consent was obtained from all participants, all tests will be done with de-personalized records, and all statistical analyses and reporting will be completed anonymously. Follow-up of participants will be ensured using participant-specific study identification numbers provided at enrollment. Study team is composed of academic personnel of 10 selected departments, nursing support is provided by the Students' Health Center in the Campus, and dental faculty are assigned for obtaining informed during the 4 subsequent study visits. The budget of the study is provided by the Hacettepe University Scientific Research Projects Office (BAP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2021
CompletedFirst Submitted
Initial submission to the registry
October 31, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2023
CompletedFebruary 28, 2024
February 1, 2024
2.5 years
October 31, 2021
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Vaccine-induced immunity (status and durability) against SARS-CoV-2
Anti-SARS-CoV-2 Spike 1 RBD antibodies are measured as a surrogate measure for vaccine-induced immunity
21 June 2021-7 July 2023
General health status (physical, mental, social)
Status and change in the self-reported morbidity and validated scales-based mental health status and quality of life will be followed over time.
21 June 2021-7 July 2023
Secondary Outcomes (1)
COVID-19 infection and related health complications
21 June 2021-7 December 2023
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- \) 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University, Sıhhiye Campus
Ankara, 06100, Turkey (Türkiye)
Related Publications (1)
E. Karadogan Et Al. ,
BACKGROUND
Related Links
Biospecimen
Venous blood samples are drawn, at fasting
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Banu Cakir
Hacettepe University, Division of Epidemiology (Chair)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2021
First Posted
November 3, 2021
Study Start
June 21, 2021
Primary Completion
December 7, 2023
Study Completion
December 7, 2023
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
All steps of the study have been completed using depersonalized data, based on participant-specific study code numbers provided at baseline visit. Individual participant data have been shared by the core study team members (n=3) only. Tabulated data have been shared with other researchers. Anonymized data have been saved for future enquiries (e.g., manuscripts, etc): Only three core team members (including principal investigator) have access to participant IDs and corresponding personal characteristics (including the national ID number).