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

N

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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