CancerNCT04910295
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
An observational study of Cancer and Covid19, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Mar 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer who are receiving or received anti-cancer drugs at Seoul National University Hospital, Seoul, Korea
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- COVID-19 vaccine
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineDrug
Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titre after vaccination
Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)
Measured: 21-28 days after completion of vaccination
Secondary outcomes (2)
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)
Measured: 21-28 days after completion of vaccination
Incidence of COVID-19 infection
Incidence of actual COVID-19 infection
Measured: 6 months after completion of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start26 Mar 2021
- Primary completion30 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Hun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910295
- Sponsor's protocol ID
- H-2013-121-1206
- Status last verified
- Apr 2023
- First submitted
- 31 May 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing of IPD will be discussed and decided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
- ClinicalTrials.gov ID
- NCT04910295
- Acronym / sponsor ID
- H-2013-121-1206
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer who are receiving or received anti-cancer drugs at Seoul National University Hospital, Seoul, Korea
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineSubjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered. | Drug | – |
Primary outcome
Antibody titre after vaccination
Time frame: 21-28 days after completion of vaccination
Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG)
2 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
Incidence of COVID-19 infection
Time frame: 6 months after completion of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided. Data sharing of IPD will be discussed and decided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Covid19, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titre after vaccination (time frame: 21-28 days after completion of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.