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NCT06168032 | RECRUITING | COVID-19 Recurrent

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

Peking Union Medical College Hospital

Brief 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.

Condition or disease

COVID-19 Recurrent

Lung Cancer

Vaccination

Antibody

Chemotherapy

Immune Checkpoint Inhibitor

Intervention/treatment

Any Chinese government-recommended COVID-19 booster vaccine

Phase

NA

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
Estimated Enrollment : 1224 participants
Masking : NONE
Primary Purpose : PREVENTION
Official 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
Actual Study Start Date : 2023-12-08
Estimated Primary Completion Date : 2026-12-08
Estimated Study Completion Date : 2026-12-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Location Details

NCT06168032

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Locations

RECRUITING

China,

Peking Union Medical College Hospital

Beijing, China,