NCT05018078

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

The Fifth Medical Center of Chinese PLA General Hospital

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Cancers
• COVID-19
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Coronavirus vaccine	Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

Timeline

• Start date: 2021-08-30
• Primary completion: 2023-08-30
• Completion: 2023-10-30
• First posted: 2021-08-24
• Last updated: 2023-06-27

Locations

1 site across 1 country: China