Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01KG1424)
Text and Data Mining valid from 2018-05-25
Received: 18 January 2018
Accepted: 2 May 2018
First Online: 25 May 2018
Ethics approval and consent to participate
: The study protocol has been approved by the Ethics Committee of the Medical Faculty of the Heinrich Heine University (leading Ethics Committee) and the respective Advisory Ethics Committees of the participating centers (MC-LKP-921, protocol ID: GlioVax). Written informed consent will be obtained from each patient, using the consent form approved by the Ethics Committees. It will be ensured that patients understand the procedures and risks of participating in the clinical trial, and only patients in a cognitive state to understand and sign the informed consent, indicating that they are aware of the investigational nature and the procedures of the study, will be eligible. Patients are informed that medical records may be examined by representatives of the sponsor (monitor, auditor, members of the DSMC), by the appropriate Ethics Committee members and by inspectors from the regulatory authorities. Moreover, must give their consent that tumor material and blood are transferred to the vaccine production site, processed and assessed for suitability for vaccine production, which includes infectious disease testing. Furthermore, patients agree that blood samples are used for immunomonitoring and that cells may be stored for later assessment of anti-tumoral immunity and tumor immunosuppressiveness.
: All authors have read and approved the manuscript.
: The authors declare that they have no competing interests.Sponsor and funder are non-commercial. The sponsor keeps responsibility and oversight in the planning, initiation and conduct of the clinical trial regarding compliance to GCP and applicable laws. The funder had no role in the design of this study and will not have any role during its execution, analysis, interpretation of the data or decision to submit results.
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