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NCT Number: NCT05313074

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

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.

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Key information

Conditions

COVID-19 Cancer Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoronaVac vaccine

Biological

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

Other names: Sinovac

Primary outcomes

  1. Immune response of Coronavac vaccine in Thai cancer patients

    Time frame: 15 days after 2 doses of vaccination

    Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Thailand

Other Gov

Collaborators

  • Mahidol University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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