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

National Cancer Institute, Thailand

Status: Completed

Conditions: COVID-19; Cancer

Treatments: Biological: CoronaVac vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05313074

013_2021RC_IN695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 2 patient groups, including a placebo group

Healthy volunteers

Placebo Comparator group

Description:

Healthcare workers at National Cancer Institute

Treatment:

Biological: CoronaVac vaccine

Cancer patients

Active Comparator group

Description:

Cancer patients were divided into 3 groups based on treatment status including active cancer on treatment Planned to start treatment Post-treatment (<6 months)

Treatment:

Biological: CoronaVac vaccine