E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
multiple myeloma chronic lymphocytic leukemia, non-Hodgkin lymphoma, |
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E.1.1.1 | Medical condition in easily understood language |
haematological disease defined as: MM, CLL, NHL |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066481 |
E.1.2 | Term | Hematological malignancy |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a haematological disorder to SARS-CoV-2 vaccination? |
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E.2.2 | Secondary objectives of the trial |
1. What is the efficacy of Anti-SARS-COV-2 vaccination 3. What is the cumulative incidence of severe COVID-19 after SARS-CoV- 2 vaccination? 4. Is there a correlation between cellular and humoral immune responses after vaccination. 5. Is the quality of immune responses induced by vaccination associated with the risk of symptomatic COVID-19? 6. Is there a relationship between pre-vaccination immune status on responses after vaccination? 7. Is there a relationship between hematological diagnosis and immune responses after SARS-CoV-2 vaccination? 8. Is there a relationship between recent or current treatment and quality responses after SARS-CoV-2 vaccination? 9. What time point after hematological treatment is best to receive SARS-CoV-2 vaccination? 10. What is the persistence of SARS-CoV-2 antibody and specific T cell responses after SARS-CoV-2 vaccination? 11. Safety of SARS-CoV-2 vaccination in haematological patients? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
all of the following criteria: • Currently treated, previously treated and non-treated patients diagnosed with the hematological malignancy multiple myeloma, chronic lymphocytic leukemia, non-Hodgkin lymphoma. "Previously treated patient" is defined as: treatment < 6 months before vaccination in patients that obtained a complete remission. Exceptions (no time restriction for last treatment) are patients with palliative treatment for ongoing haematological malignancies and patients after autologous and allogeneic stem cell transplantation. • Patients who are scheduled for and will undergo SARS-CoV-2 vaccination. • Aged ≥ 18 years. • Written informed consent. • Inclusion is irrespective of previously proven or possible (based on symptoms) COVID-19 |
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E.4 | Principal exclusion criteria |
excluded from participation in this study: • Patients previously vaccinated for SARS-CoV-2. • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent. • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Presence of Anti-SARS-CoV-2 S-protein specific antibodies one month after vaccination (yes/no) of hematological patients that were seronegative for these antibodies before vaccination. |
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E.5.2 | Secondary end point(s) |
* Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. In addition, a disease and treatment matched control group that did show an antibody response will be tested for SARS-CoV-2 specific T cell responses. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition) * SAE and SUSARS within 12 months after vaccination. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
* Titers of anti- SARS-CoV-2 S protein specific antibodies in AU/ml prevaccination and 1, 3 and 6 months post-vaccination. • Presence and percentage of SARS-CoV-2 S protein specific peptideactivated CD8 and CD4 cells pre-vaccination and 1 and 6 months postvaccination. This will only be analyzed in a subpopulation of patients that did not develop any SARS-CoV-2 S specific antibodies. * Incident of severe COVID-19 infection within 12 months after vaccination, defined by hospitalization and/or death due to COVID-19 and positive SARS-CoV-2 PCR. Clinical severity will be scored according to the Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition). * SAE and SUSARS within 12 months after vaccination. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |