SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Primary Purpose
COVID-19, Cancer
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
CoronaVac vaccine
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Cancer, Immune response
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
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Healthy volunteers
Cancer patients
Arm Description
Healthcare workers at National Cancer Institute
Cancer patients were divided into 3 groups based on treatment status including active cancer on treatment Planned to start treatment Post-treatment (<6 months)
Outcomes
Primary Outcome Measures
Immune response of Coronavac vaccine in Thai cancer patients
Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05313074
First Posted
April 4, 2022
Last Updated
April 9, 2022
Sponsor
National Cancer Institute, Thailand
Collaborators
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT05313074
Brief Title
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Official Title
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Thailand
Collaborators
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Cancer
Keywords
COVID-19, Cancer, Immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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
Allocation
Non-Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Placebo Comparator
Arm Description
Healthcare workers at National Cancer Institute
Arm Title
Cancer patients
Arm Type
Active Comparator
Arm Description
Cancer patients were divided into 3 groups based on treatment status including
active cancer on treatment
Planned to start treatment
Post-treatment (<6 months)
Intervention Type
Biological
Intervention Name(s)
CoronaVac vaccine
Other Intervention Name(s)
Sinovac
Intervention Description
An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.
Primary Outcome Measure Information:
Title
Immune response of Coronavac vaccine in Thai cancer patients
Description
Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients
Time Frame
15 days after 2 doses of vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanarath Imsuwansri, MD
Organizational Affiliation
National Cancer Institute of Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
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