| Condition or disease |
|---|
| Melanoma Non Small Cell Lung Cancer |
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 |
| 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 |
| 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
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Sibylle C Mellinghoff, MD | +49 221 478 ext 85523 | sibylle.mellinghoff@uk-koeln.de |
| 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 | |
| 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 |
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 |
|
||||
| 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 |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
||||
| 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 |
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:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
|
||||
| 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 |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Sibylle C Mellinghoff, University of Cologne | ||||
| Study Sponsor | University of Cologne | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | University of Cologne | ||||
| Verification Date | April 2021 | ||||