NCT06168032

COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,224 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.

Detailed description

A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.

Conditions

• COVID-19 Recurrent
• Lung Cancer
• Vaccination
• Antibody
• Chemotherapy
• Immune Checkpoint Inhibitor

Interventions

Type	Name	Description
BIOLOGICAL	Any Chinese government-recommended COVID-19 booster vaccine	Any Chinese government-recommended COVID-19 booster vaccine(such as Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) and so on) will be once administered in the sixth month after COVID19 infection.

Timeline

• Start date: 2023-12-08
• Primary completion: 2026-12-08
• Completion: 2026-12-08
• First posted: 2023-12-13
• Last updated: 2023-12-13

Locations

1 site across 1 country: China