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

NCT05313074 | Completed

• 1 other identifier: 013_2021RC_IN695
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Cancer

Keywords

COVID-19; Cancer; Immune response

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy volunteers

PLACEBO COMPARATOR

Healthcare workers at National Cancer Institute

Biological: CoronaVac vaccine

Cancer patients

ACTIVE COMPARATOR

Cancer patients were divided into 3 groups based on treatment status including 1. active cancer on treatment 2. Planned to start treatment 3. Post-treatment (\<6 months)

Biological: CoronaVac vaccine

Interventions

CoronaVac vaccine BIOLOGICAL

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

Also known as: Sinovac

Cancer patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients who cannot provide consent

Sponsors & Collaborators

• National Cancer Institute, Thailand: lead
• Mahidol University: collaborator

Study Sites (1)

National Cancer Institute

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thanarath Imsuwansri, MD

  National Cancer Institute of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Division

Model Details: 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

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 6, 2022
• Study Start: March 23, 2021
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

TH (1)