Actively Recruiting
Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in Lung Cancer Patients Receiving Systemic Anti-cancer Treatment
Led by Peking Union Medical College Hospital · Updated on 2023-12-13
1224
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a single COVID-19 booster dose in lung cancer patients undergoing systemic anti-cancer treatments. This study compares rates of repeated COVID-19 infection, severe lung inflammation, and death between patients who receive a booster (mostly targeting XBB variant) and those who choose not to get vaccinated. Additionally, the study monitors specific antibody levels in the blood to understand their relationship with breakthrough infections and to find the best timing for vaccination. Participants who choose vaccination will receive one booster dose about six months after their latest symptomatic COVID-19 infection. Both vaccinated and non-vaccinated groups will be observed for six months to track any repeated infections, severe COVID-19 cases, and mortality. Blood samples will be taken at 3, 4.5, and 6 months after the last infection and after vaccination to analyze antibody changes. During the study, participants will have regular check-ups to record health events and provide blood samples for antibody testing. Researchers will measure how often reinfections and severe COVID-19 occur, overall survival, and adverse events related to cancer treatments or vaccination. The total follow-up period for each participant after vaccination or non-vaccination is six months, with additional safety and survival monitoring up to eight weeks after the booster dose.
CONDITIONS
Brief Title
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who agree to participate in the trial and sign the informed consent.
- Male or female, aged 18 years or older.
- Diagnosed with lung carcinoma by histological or cytological examinations.
- Currently undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy, or targeted therapy.
- Have a recorded history of COVID-19 infection.
- Have sufficiently functional organs.
- Eastern Cooperative Oncology Group performance status score between 0 and 2.
You will not qualify if you...
- Life expectancy less than 3 months.
- Less than 3 months since last confirmed COVID-19 infection.
- Unable to return to the hospital for follow-up visits.
- Allergic to COVID-19 vaccine.
- History of severe treatment-related adverse events graded 3 or higher, including those caused by antitumor therapies or immunization, except recoverable granulocytopenia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single booster dose of a government-recommended COVID-19 vaccine six months after their latest symptomatic COVID-19 infection, depending on their willingness.
1 visit (in-person)
Duration - 3 months
Blood samples are collected from participants for antibody analysis at the 3rd, 4.5th, and 6th months after the latest symptomatic infection and at the same timepoints after booster vaccination.
3 visits (in-person)
Duration - 6 months
Participants are monitored for recurrent symptomatic COVID-19 infection, critical or severe conditions, and all-cause death for 6 months after booster vaccination or the equivalent period if not vaccinated.
Regular monitoring visits during follow-up period
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
M
Mengzhao Wang, MD
Y
Yan Xu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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