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

NCT ID: NCT03989050

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-06-01

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.

Detailed Description

Physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. Patients currently receiving Immune Checkpoint Inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against S. pneumonia. If a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irAE will be obtained from the electronic health record and entered into the eCRF.

Pneumococcal antibody titers will be drawn at baseline and after 30 days. We will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irAE.

A blood sample (9 ml) will be drawn before vaccination. Vaccination will either be performed by the treating physician or by a general practitioner. 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.

All samples for ELISA and OPA titer determination will be stored frozen at Department I for Internal Medicine and titers will be analyzed in batch at the end of this study. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (RKI STIKO recommendations).

Conditions

Melanoma; Non Small Cell Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Melanoma patients

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

No interventions assigned to this group

Non-small cell lung cancer (NSCLC) patients

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

No interventions assigned to this group

other malignancy patients

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Sibylle C Mellinghoff

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibylle C Mellinghoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

HELIOS University Hospital Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

SPICE

Identifier Type: -

Identifier Source: org_study_id