Immunogenicity and Safety of COVID-19 Vaccine in Cancer P... | NCT04910295

Studies
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

NCT04910295

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 12, 2023Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Cancer
Covid19

Interventions

COVID-19 vaccine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 vaccine	Drug	Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)	21-28 days after completion of vaccination
Incidence of COVID-19 infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000086663	COVID-19 Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided