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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Chemotherapy; Antibody; COVID-19 Recurrent; Vaccination; Immune Checkpoint Inhibitor
• Intervention / Treatment: Biological: Any Chinese government-recommended COVID-19 booster vaccine

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.

• Study Type: Interventional
• Enrollment (Estimated): 1224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengzhao Wang, MD; Phone Number: +8613911235467; Email: mengzhaowang@sina.com
• Study Contact Backup: Name: Yan Xu, MD; Phone Number: +8618500296828; Email: maraxu@163.com

Study Locations

• China
  • Peking, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yan Xu, MD; Phone Number: +8618500296828; Email: maraxu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccinated group; Any booster doses(without limitations in the subtypes or brands of the vaccines) recommended or approved by Chinese government will be administered once in the 6th months after latest confirmed COVID-19 infection and during the following 6 months, any conditions including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded.	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.
No Intervention: Non-vaccinated group; Patients unwilling to get vaccination will be allocated into these group, but any events including recurrent COVID19 infection, critical and/or severe conditions and all-cause death will be recorded in the following six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of recurrent symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.	The incidence of any of the following events: confirmed COVID 19 infection by antigen test or PCR test, with at least one related symptom including fever, cough, expectoration, dyspnea, headache, diarrhea and so on.	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of critical and/or severe symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.	The incidence of the following events: COVID 19 infection confirmed by antigen test or PCR test and diagnosed of critical and/or severe pneumonitis.	up to 8 weeks
All-cause mortality rate	The proportions of patients who died from any causes after enrollment.	up to 8 weeks
Overall survival	The time length from enrollment to death from any causes.	up to 8 weeks
Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Evaluate adverse events of any cause(except cancer-related events), treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0.	up to 8 weeks
Incidence of adverse events following immunization	Evaluate immunization-related adverse events including local or systemic symptoms(excluding those caused by cancer or anti-canter treatments like chemotherapies, tyrosine kinase inhibitors, immune checkpoint inhibitors and so on）	up to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory biomarker analysis	5 ml blood samples will be collected in the 3rd ,4.5th and 6th months after symptomatic infection and at the same timepoints after booster dose vaccination(the interventional group) or of the successive 6 months(control group) to monitor the titre of specific sero-antibodies against COVID-19.	up to 8 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Mengzhao Wang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 8, 2023
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; COVID-19; Lung Neoplasms
• Other Study ID Numbers: K4846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The result of the study and all the supporting information will be shared in the form of published article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No