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NCT07885540

PHASE4

Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

Postoperative pneumonia (POP) affects 4%-24% of lung cancer surgery patients, increasing mortality, stay, costs and worsening prognosis, especially in older patients. Perioperative immunosuppression and synergistic influenza/pneumococcal infection support perioperative vaccination, which may also induce trained immunity; thoracic surgery data are lacking. This multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial will enroll \~1278 patients aged ≥50 undergoing anatomical lung resection for pulmonary nodules or lung cancer, randomized 1:1 to vaccination or no vaccination, with 180-day follow-up. Randomization uses a computer-generated, site-stratified block sequence, concealed via central IWRS or sealed envelopes. An unblinded team handles screening, randomization and vaccination data; surgeons and assessors are blinded. No site may exceed 50% of enrollment. Vaccination group receives 23-valent pneumococcal polysaccharide and quadrivalent influenza vaccines intramuscularly in separate arms 14-28 days preoperatively. Controls receive no vaccine/placebo, with surgery scheduled 14-28 days after randomization. Concomitant indicated treatments are permitted and recorded. Primary endpoint is POP per modified CDC/NHSN criteria: new/progressive imaging infiltrate (excluding atelectasis, edema, embolism, tumor), plus ≥1 clinical sign (fever \>38 °C, WBC ≤4000 or ≥12,000/mm³, or altered mental status if ≥70 years) and ≥2 respiratory signs. Findings on days 3-5 are excluded unless persistent/worsening. Microbiology is confirmatory, not required.

Official title: Preoperative Respiratory Infectious Disease Vaccination (23-Valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Split-Virion Influenza Vaccine) for the Prevention of Postoperative Pulmonary Infection in Patients With Pulmonary Nodules/Lung Cancer: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint (PROBE) Clinical Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1278

Start Date

2026-11-01

Completion Date

2028-09-30

Last Updated

2026-10-21

Healthy Volunteers

Yes

Conditions

Pneumococcal Polysaccharide Vaccine Influenza Vaccines Preoperative Lung Resection Surgery Thoracic Surgery

Interventions

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Single 0.5 mL intramuscular dose in one upper arm, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.

BIOLOGICAL

Quadrivalent split-virion influenza vaccine

Single 0.5 mL intramuscular dose in the opposite upper arm from the pneumococcal vaccine, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.

Inclusion Criteria: * Age 50 years or older, any sex * American Society of Anesthesiologists (ASA) physical status I to III * Pulmonary nodule or lung cancer scheduled, based on imaging evaluation, for anatomical lung resection (including segmentectomy, lobectomy, sleeve resection, etc.) * Expected postoperative survival of at least 6 months * Agrees to wait 14 to 28 days after enrollment before surgery * Signed informed consent and willing to comply with the study protocol Exclusion Criteria: * Previous pneumococcal vaccination within 5 years, influenza vaccination within 1 year, or any other vaccination within 4 weeks * Known allergy to any vaccine component * Active autoimmune or inflammatory disease (e.g., Guillain-Barre syndrome, systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, Hashimoto thyroiditis); type 1 diabetes, hypothyroidism controlled by replacement therapy alone, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis) are allowed * HIV antibody positive; active tuberculosis; active hepatitis B (HBV-DNA above the lower limit of detection); or active hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection) * Pulmonary infection, or active infection requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), within 1 month before surgery * Use of antibiotics or antiviral drugs within 1 month before surgery * History of allogeneic organ transplantation (solid organ or allogeneic bone marrow) * Other surgery or invasive treatment within 1 month before surgery (diagnostic needle biopsy excluded) * Emergency surgery, or risk of disease progression (e.g., short tumor doubling time) that does not allow waiting for the 14-day vaccine response window * Pregnant or breastfeeding women * Prior neoadjuvant therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.), or planned adjuvant therapy within 30 days after surgery * Any serious illness, uncontrolled concurrent disease, psychiatric disorder, active or uncontrolled infection, other medical history or laboratory abnormality that, in the investigator's opinion, may interfere with participation or interpretation of results

Clinical Research Directory

Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria