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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19, Cancer

Intervention / Treatment
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* Biological: CoronaVac vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Healthy volunteers<br>Healthcare workers at National Cancer Institute | Biological: CoronaVac vaccine<br>* An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.<br>* Other names: Sinovac;|
| Active Comparator: Cancer patients<br>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<br>* An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.<br>* Other names: Sinovac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Cancer, Immune response