NCT04910295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

May 31, 2021

Last Update Submit

April 10, 2023

Conditions

CancerCovid19

Outcome Measures

Primary Outcomes (1)

  • Antibody titre after vaccination

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

    21-28 days after completion of vaccination

Secondary Outcomes (2)

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

    21-28 days after completion of vaccination

  • Incidence of COVID-19 infection

    6 months after completion of vaccination

Interventions

COVID-19 vaccineDRUG

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

NeoplasmsCOVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 2, 2021

Study Start

March 26, 2021

Primary Completion

April 30, 2022

Study Completion

December 31, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

KR(1)