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

Not Applicable

Completed

• Conditions: Cancer; COVID-19
• Interventions: Biological: CoronaVac vaccine

• Registration Number: NCT05313074
• Lead Sponsor: National Cancer Institute, Thailand

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.

Study Timeline

• Study Start: 2021-03-23
• Primary Completion: 2022-02-25
• Study Completion: 2022-02-25
• Status Verified: 2022-04
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-06
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cancer patients	CoronaVac vaccine	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)
Healthy volunteers	CoronaVac vaccine	Healthcare workers at National Cancer Institute

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Institute; 🇹🇭 Ratchathewi, Bangkok, Thailand