Clinical trial NCT03989050: Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
Official title: Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanoma
Non Small Cell Lung Cancer
Keywords: Immune Checkpoint Inhibitor
Pneumococcal Vaccination
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia

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).

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

Primary outcomes:
measure: Pneumococcal antibody kinetics
timeFrame: 1 Month
Secondary outcomes:
measure: Determination of applicability of current assessment methodology
timeFrame: 1 year
measure: Incidence of irAE
timeFrame: 1 year
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Wuppertal
country: Germany
facility: HELIOS University Hospital Wuppertal
state: NRW
Study officials:
affiliation: University of Cologne
name: Sibylle C Mellinghoff, MD
role: PRINCIPAL_INVESTIGATOR
References: