Non-Small Cell Lung Cancer Cancer
Conditions
Interventions
VISIT 1: Initial patient assessment clinic (surgical/oncology)*
Inform patient about study, hand out patient information sheet (PIS), and check if patient has had PPSV23 vaccination in
progression-free and overall survival
4. Samples: Blood clotted 6 ml (red top), Blood EDTA 6 ml (purple top), Blood Vacutainer CPT 3*8 ml (24 ml)
VISIT 4: 52 week (+/-
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is able to give informed consent and undertake the patient assessment as detailed in the protocol 2. Patient has resectable NSCLC and be scheduled for surgical resection of the NSCLC from the time of baseline blood withdrawal OR has advanced disease NSCLC that is eligible for chemo/immunotherapy 3. Patient is aged 65 or over OR patient is aged between 18 to 65 years AND have a long-term health condition such as COPD, diabetes, chronic kidney disease or liver disease, and therefore meeting standard of care requirements for PPSV23 vaccination
Exclusion criteria
Exclusion criteria: 1. Previously vaccinated with the PPSV23 vaccine in the last 5 years 2. Oral steroids or other form of immunosuppression that will affect vaccine response 3. Suppressed immune system caused by a health condition such as HIV 4. Allergic to components of the study vaccines 5. Suffering from an acute infective illness (as determined by the clinician at visit 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Functional in vivo B cell response measured using serum immunoglobulin levels by class and by antibodies specific for bacterial and viral target antigens using standard laboratory ELISA and multiplex immunoassays including functional antibody tests (clotted blood). Tests include Luminex, opsonophagocytic killing assays (OPKA) and total IgG, A and M. Measured at 4 weeks (+/- 7 days) and 52 weeks (+/- 7 days) post vaccination 2. Lymphocyte subset numbers, measured using mass cytometry at baseline, 4 weeks and 52 weeks 3. Antigen-specific B cell phenotyping measured by ELISpot and CyTOF (cytometry by time of flight method)] at 4 weeks (+/- 7 days) and 52 weeks (+/- 7 days) post vaccination 4. The feasibility of carrying out this study using the proposed research methods in the NSCLC cohorts described. Feasibility is defined in terms of study uptake rates (% of those approached who are recruited), recruitment rates (n/month) and retention rates (% of those who provide samples and data at follow-up appointments) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Outcome or prognosis in this cohort of patients, measured by collecting data on overall survival and progression free survival in days and correlating with imaging data and clinical entries from routine follow-up visits with surgical or oncology teams, at 3, 6 and 12 months 2. Functional immune response assessed with serial blood samples and laboratory testing of biomarkers of specific adaptive immunity (as those listed above) at baseline, 4 weeks and 52 weeks | — |
Countries
United Kingdom
Outcome results
None listed