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

Melanoma Clinical Trial

— SPICE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03989050
• Other study ID #: SPICE
• Status: Withdrawn
• Start date: January 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Melanoma
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW
Germany	HELIOS University Hospital Wuppertal	Wuppertal	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumococcal antibody kinetics	Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI	1 Month
Secondary	Determination of applicability of current assessment methodology	Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI	1 year
Secondary	Incidence of irAE	Assessment of the incidence of irAE in patients vaccinated during ICI treatment	1 year