RecruitingNot ApplicableNCT06168032

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

Sponsor

Peking Union Medical College Hospital

Enrollment

1,224 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Patients who agree to participate in the trial and sign the informed consents.
Male or female, ≥18 years old.
Diagnosed of lung carcinoma by histological and cytological examinations.
Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
Recorded history of COVID19 infection.
Sufficiently functional organs.
Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.

Exclusion Criteria5

Life expectance less than 3 months.
Less than 3 months since last confirmed COVID-19 infection.
Patients unable to return the hospital for follow-up.
Patients allergic to COVID-19 vaccine.
Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

Interventions

BIOLOGICALAny 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.