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NCT Number: NCT06168032

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

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.

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Key information

Conditions

COVID-19 Recurrent Antibody Chemotherapy Immune Checkpoint Inhibitor Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Vaccination

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Any Chinese government-recommended COVID-19 booster vaccine

Biological

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.

Primary outcomes

  1. 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.

    Time frame: up to 8 weeks

    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.

Secondary outcomes

  1. 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.

    Time frame: up to 8 weeks

    The incidence of the following events: COVID 19 infection confirmed by antigen test or PCR test and diagnosed of critical and/or severe pneumonitis.

  2. All-cause mortality rate

    Time frame: up to 8 weeks

    The proportions of patients who died from any causes after enrollment.

  3. Overall survival

    Time frame: up to 8 weeks

    The time length from enrollment to death from any causes.

  4. Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Time frame: up to 8 weeks

    Evaluate adverse events of any cause(except cancer-related events), treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0.

  5. Incidence of adverse events following immunization

    Time frame: up to 8 weeks

    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）

Other outcomes

  1. Exploratory biomarker analysis

    Time frame: up to 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mengzhao Wang, MD

CONTACT

[email protected]

+8613911235467

Yan Xu, MD

CONTACT

[email protected]

+8618500296828

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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