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

Sponsor
National Cancer Institute, Thailand (Other)
Overall Status
Completed
CT.gov ID
NCT05313074
Collaborator
Mahidol University (Other)
311
Enrollment
1
Location
2
Arms
11.1
Actual Duration (Months)
27.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CoronaVac vaccine
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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 testCancer 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
Primary Purpose:
Prevention
Official Title:
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Actual Study Start Date :
Mar 23, 2021
Actual Primary Completion Date :
Feb 25, 2022
Actual Study Completion Date :
Feb 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Healthy volunteers

Healthcare workers at National Cancer Institute

Biological: CoronaVac vaccine
An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.
Other Names:
  • Sinovac

    		•
    Active Comparator: Cancer patients

    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
    An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.
    Other Names:
  • Sinovac

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immune response of Coronavac vaccine in Thai cancer patients [15 days after 2 doses of vaccination]

      Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute Ratchathewi Bangkok Thailand 10400

    Sponsors and Collaborators

    • National Cancer Institute, Thailand
    • Mahidol University

    Investigators

    • Principal Investigator: Thanarath Imsuwansri, MD, National Cancer Institute of Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thanarath Imsuwansri, MD, Head of Research Division, National Cancer Institute, Thailand
    ClinicalTrials.gov Identifier:
    NCT05313074
    Other Study ID Numbers:
    • 013_2021RC_IN695
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Thanarath Imsuwansri, MD, Head of Research Division, National Cancer Institute, Thailand
    COVID-19
    Cancer
    Immune response
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 15, 2022