Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

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.

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Key information

Conditions

Cancer COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

COVID-19 vaccine

Drug

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

Primary outcomes

Antibody titre after vaccination

Time frame: 21-28 days after completion of vaccination

Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)

Secondary outcomes

Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics

Time frame: 21-28 days after completion of vaccination

Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)
Incidence of COVID-19 infection

Time frame: 6 months after completion of vaccination

Incidence of actual COVID-19 infection

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 2, 2021
Registry last updated: Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed