Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

June 24, 2023 updated by: Beijing 302 Hospital

The Fifth Medical Center of Chinese PLA General Hospital

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, single-arm, open-label clinical trial. A total of 300 patients with different cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fu-Sheng Wang, MD
  • Phone Number: 8610-66933332
  • Email: fswang@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Fu-Sheng Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age above 18 years
  2. Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included .
  3. Patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ECOG score below 2.
  4. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion Criteria:

  1. Patients with acute attack of chronic diseases.
  2. Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
  3. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
  4. Pregnant or lactating women.
  5. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
  6. Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.
  7. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coronavirus vaccination
Patients in the experimental need to accept the coronavirus vaccination
Biological: Coronavirus vaccine
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of coronavirus vaccine
Time Frame: Within 2 months after the first dose of coronavirus vaccine
Occurence of adverse effects after COVID-19 vaccination
Within 2 months after the first dose of coronavirus vaccine
Immunogenicity of coronavirus vaccine
Time Frame: Within 2 months after the first dose of coronavirus vaccine
Titers of anti-SARS-CoV-2 antibodies
Within 2 months after the first dose of coronavirus vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of coronavirus vaccine
Time Frame: Within 13 months after the first dose of coronavirus vaccine
Occurence of adverse effects after COVID-19 vaccination
Within 13 months after the first dose of coronavirus vaccine
Immunogenicity of coronavirus vaccine
Time Frame: Within 13 months after the first dose of coronavirus vaccine
Titers of anti-SARS-CoV-2 antibodies
Within 13 months after the first dose of coronavirus vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Study Director: Shu-juan Li, MD, Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky-2021-7-9-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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