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

Not Applicable

Recruiting

• Conditions: COVID-19; Patients With Cancers; Vaccine
• Interventions: Biological: Coronavirus vaccine

• Registration Number: NCT05018078
• Lead Sponsor: Beijing 302 Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-24
• Study Start: 2021-08-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27
• Primary Completion: 2023-08-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronavirus vaccination	Coronavirus vaccine	Patients in the experimental need to accept the coronavirus vaccination

Primary Outcome Measures

Name	Time	Method
Safety of coronavirus vaccine	Within 2 months after the first dose of coronavirus vaccine	Occurence of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine	Within 2 months after the first dose of coronavirus vaccine	Titers of anti-SARS-CoV-2 antibodies

Secondary Outcome Measures

Name	Time	Method
Safety of coronavirus vaccine	Within 13 months after the first dose of coronavirus vaccine	Occurence of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine	Within 13 months after the first dose of coronavirus vaccine	Titers of anti-SARS-CoV-2 antibodies

Trial Locations

Locations (1)

The Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China