E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Onco-hematological patients |
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E.1.1.1 | Medical condition in easily understood language |
Onco-hematological patients |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The central question is whether patients under active treatment, can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the medical oncology community to decide whether optimal cancer care can be delivered safely to vaccinated patients with cancer. The primary objective is to assess the immune response and adverse events after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in an oncology population of 200 patients under active treatment. In a meanwhile the results of the B-VOICE study revealed that the amount of binding antibodies produced by day 28 after full BNT161b2 vaccination is lower than expected for the vast majority of the cohort cancer patients. We absolutely do not want to lag behind the facts and will therefore administer a 3th and 4th dose of BNT161b2.
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E.2.2 | Secondary objectives of the trial |
•To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®).
ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE study
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age of 18 years or older • Patients should meet one of the cohort criteria • Life expectancy > 12 months • Ability to provide informed consent
ADDENDUM extra booster shot • Former participant of the B-VOICE study • Vaccinated with priming and boosting BNT162b2 vaccine • Ability to provide informed consent
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E.4 | Principal exclusion criteria |
• Women who are pregnant or breastfeeding • Immune deficiency not related to cancer or cancer treatment • Systemic treatment with immune suppressive medication, including chronic steroid use of >10 mg prednisone or equivalent
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E.5 End points |
E.5.1 | Primary end point(s) |
neutralizing antibody titers against the SARS-CoV-2 spike protein and nucleocapsid protein on day 28 after second vaccination in patients receiving active cancer treatment.
ADDENDUM extra booster shot The first co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after administration of a third dose of the COVID-19 mRNA BNT162b2 vaccine upon previous receipt of 2 doses of this vaccine.
The second co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after administration of a fourth dose of the COVID-19 mRNA BNT162b2 vaccine upon previous receipt of 3 doses of this vaccine.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 28 after second vaccination
ADDENDUM extra booster shot day 28 after 3th vaccination day 28 after 4th vaccination |
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E.5.2 | Secondary end point(s) |
•To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®).
ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE studyy
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |