Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors

NCT03989050 | Withdrawn

• 1 other identifier: SPICE
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Melanoma; Non Small Cell Lung Cancer

Keywords

Immune Checkpoint Inhibitor; Pneumococcal Vaccination

Outcome Measures

Primary Outcomes (1)

• Pneumococcal antibody kinetics

  Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI

  1 Month

Secondary Outcomes (2)

• Determination of applicability of current assessment methodology

  1 year

• Incidence of irAE

  1 year

Study Arms (3)

Melanoma patients

Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for melanoma

Non-small cell lung cancer (NSCLC) patients

Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for NSCLC

other malignancy patients

Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for other malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

HELIOS University Hospital Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained for determination of pneumococcal antibody-titers during clinical routine care. One sample will be drawn before vaccination. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients.

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sibylle C Mellinghoff, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 18, 2019
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

DE (2)