Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

April 10, 2023 updated by: Kyung-Hun Lee, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with cancer who are receiving or received anti-cancer drugs at Seoul National University Hospital, Seoul, Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody titre after vaccination
Time Frame: 21-28 days after completion of vaccination
Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)
21-28 days after completion of vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
21-28 days after completion of vaccination
Incidence of COVID-19 infection
Time Frame: 6 months after completion of vaccination
Incidence of actual COVID-19 infection
6 months after completion of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2013-121-1206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing of IPD will be discussed and decided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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