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NCT05313074 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05313074
Other study ID # 013_2021RC_IN695
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2021
Est. completion date February 25, 2022

Study information
Verified date April 2022
Source National Cancer Institute, Thailand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 311
Est. completion date February 25, 2022
Est. primary completion date February 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand National Cancer Institute Ratchathewi Bangkok

Sponsors (2)
Lead Sponsor Collaborator
National Cancer Institute, Thailand Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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