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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05313074
Enrollment
311
Registered
2022-04-06
Start date
2021-03-23
Completion date
2022-02-25
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, COVID-19

Keywords

COVID-19, Cancer, Immune response

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.

Interventions

An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.

Sponsors

Mahidol University
CollaboratorOTHER
National Cancer Institute, Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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

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 test

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Immune response of Coronavac vaccine in Thai cancer patients15 days after 2 doses of vaccinationImmune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026