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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04910295
Other study ID # H-2013-121-1206
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 26, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - 20 years of age or older - Patients who are receiving or received anti-cancer drugs - Those who are not vaccinated against COVID-19 at the time of enrollment - Written informed consent Exclusion Criteria: - Any contraindications to COVID-19 vaccines - Those who were already vaccinated - Those who are on immunosuppressants or infected with HIV - Those who underwent organ transplantation - Active infections (for example, pneumonia)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
COVID-19 vaccine
Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody titre after vaccination Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG) 21-28 days after completion of vaccination
Secondary Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG) 21-28 days after completion of vaccination
Secondary Incidence of COVID-19 infection Incidence of actual COVID-19 infection 6 months after completion of vaccination
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