Clinical trial · Observational
Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative reasons
Summary
Brief summary (as posted)
This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Melanoma patients
- description
- Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for melanoma
- label
- Non-small cell lung cancer (NSCLC) patients
- description
- Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for NSCLC
- label
- other malignancy patients
- description
- Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for other malignancy
Primary outcomes (1)
- measure
- Pneumococcal antibody kinetics
- timeFrame
- 1 Month
- description
- Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form * Age ≥18 years * Receiving pneumococcal vaccination for the first time along STIKO criteria * Therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agentfor melanoma, NSCLC or other malignancy Exclusion Criteria: * Patients unwilling/ineligible for vaccination under current STIKO recommendations * Previous vaccination with any licensed or experimental pneumococcal vaccine * Concurrent treatment with anti-CTLA-4 agent
References
Publications (0)
Data not yet available