免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors (SPICE)

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

Study Description
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.

Condition or disease
Melanoma Non Small Cell Lung Cancer

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).

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : June 1, 2024
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  1. Pneumococcal antibody kinetics [ Time Frame: 1 Month ]
    Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI


Secondary Outcome Measures :
  1. Determination of applicability of current assessment methodology [ Time Frame: 1 year ]
    Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI

  2. Incidence of irAE [ Time Frame: 1 year ]
    Assessment of the incidence of irAE in patients vaccinated during ICI treatment


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.

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sibylle C Mellinghoff, MD +49 221 478 ext 85523 sibylle.mellinghoff@uk-koeln.de

Locations
Layout table for location information
Germany
University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Sibylle C Mellinghoff, MD         
HELIOS University Hospital Wuppertal Not yet recruiting
Wuppertal, NRW, Germany, 42283
Contact: Blasius Liss, MD         
Sponsors and Collaborators
University of Cologne
Investigators
Layout table for investigator information
Principal Investigator: Sibylle C Mellinghoff, MD University of Cologne
Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 18, 2019
Last Update Posted Date April 28, 2021
Estimated Study Start Date January 1, 2022
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2019)
Pneumococcal antibody kinetics [ Time Frame: 1 Month ]
Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 17, 2019)
  • Determination of applicability of current assessment methodology [ Time Frame: 1 year ]
    Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI
  • Incidence of irAE [ Time Frame: 1 year ]
    Assessment of the incidence of irAE in patients vaccinated during ICI treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia
Condition
  • Melanoma
  • Non Small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2019)
36
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2024
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sibylle C Mellinghoff, MD +49 221 478 ext 85523 sibylle.mellinghoff@uk-koeln.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03989050
Other Study ID Numbers SPICE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sibylle C Mellinghoff, University of Cologne
Study Sponsor University of Cologne
Collaborators Not Provided
Investigators
Principal Investigator: Sibylle C Mellinghoff, MD University of Cologne
PRS Account University of Cologne
Verification Date April 2021

治疗医院