SARS-CoV-2 Specific Immune Response After COVID-19 Vaccin... | NCT05313074

Studies
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients

NCT05313074

Sponsor

National Cancer Institute, Thailand

Status

Completed

Last Update Posted

Apr 15, 2022Actual

Enrollment

311Actual

Phase

Not Applicable

Conditions

COVID-19
Cancer

Interventions

CoronaVac vaccine

Countries

Thailand

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 2022

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 23, 2021Actual

Primary Completion Date

Feb 25, 2022Actual

Completion Date

Feb 25, 2022Actual

First Submitted Date

Apr 4, 2022

First Submission Date that Met QC Criteria

Apr 4, 2022

First Posted Date

Apr 6, 2022Actual

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 9, 2022

Last Update Posted Date

Apr 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thanarath Imsuwansri, MD, Head of Research Division, National Cancer Institute, ThailandPrincipal Investigator

Lead Sponsor

National Cancer Institute, ThailandOTHER_GOV

Collaborators

Name	Class
Mahidol University	OTHER

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

Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Detailed Description

A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers	Placebo Comparator	Healthcare workers at National Cancer Institute	Biological: CoronaVac vaccine
Cancer patients	Active Comparator	Cancer patients were divided into 3 groups based on treatment status including active cancer on treatment Planned to start treatment Post-treatment (<6 months)	Biological: CoronaVac vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CoronaVac vaccine	Biological	An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.	Cancer patients Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune response of Coronavac vaccine in Thai cancer patients	Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients	15 days after 2 doses of vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female age at least 18 years
Patients with a diagnosis of solid tumors
Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
Willing and able to comply with the study procedures.
Willing to receive a Coronavac vaccine (Sinovac).

Exclusion Criteria:

Patients who cannot provide consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thanarath Imsuwansri, MD	National Cancer Institute of Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute		Ratchathewi	Bangkok	10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D009369	Neoplasms

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
C000722216	sinovac COVID-19 vaccine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test

Masking Info

Masking

None (Open Label)

Masking Description

All participants, including patients with solid tumor and healthy volunteers will be received 2 doses of CoronaVac at National Cancer Institute of Thailand between 2020-2021. Blood samples will be collected after second dose of Sinovac for 15 days and the neutralizing antibody (NAb) titers will be detected using live-virus neutralization

Who Masked

Not provided