Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

Completed

• Conditions: Cancer; Covid19

• Registration Number: NCT04910295
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titre after vaccination	21-28 days after completion of vaccination	Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of