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

April 9, 2022 updated by: Thanarath Imsuwansri, MD, National Cancer Institute, Thailand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

  1. active cancer on treatment
  2. Planned to start treatment
  3. Post-treatment (<6 months)
Biological: CoronaVac vaccine
An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.
Other Names:
  • Sinovac

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Thailand

Collaborators

Mahidol University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2021

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013_2021RC_IN695

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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