COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003710-39/PT

INSTITUT JULES BORDET - CTSU

cstu.isparc@bordet.be

2022-01-24

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

Subjects must meet all of the following criteria in order to be eligible for this study: 1) Age ≥ 18 years old 2) ECOG performance status ≤ 2 3) Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy) undergoing active systemic cancer treatment at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in - non-metastatic setting or - metastatic setting (only 1st line therapy ) or undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine 4) Life expectancy > 6 months 5) Subjects who received the 2nd dose of mRNA platform vaccination against SARS-CoV-2 as per local guidelines within 6 months (maximum until 6 months and 3 weeks) prior to registration. 6) Urine pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment. 7) Signed Informed Consent form (ICF) obtained prior to any study related procedure. 8) Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.

Subjects meeting one of the following criteria are not eligible for this study: 1) Known pregnant and/or lactating women. 2) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study. 3) Subjects with active diagnosis of acute leukaemia. 4) Subjects treated with bone marrow transplant < 90 days before received vaccination against SARS-CoV-2. 5) Subjects with a known history of HIV infection. 6) COVID-19 infection in the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment. 7) Subjects receiving prolonged and/or high doses of systemic immunosuppressive therapies including corticosteroids during the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment.8) Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA vaccine. 9) Subjects that received the 3rd dose of anti-SARS-CoV-2 mRNA vaccine prior to study entry. 10) Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform. 11) Subjects with a known or suspected history of severe adverse reactions associated with a vaccine and/or with severe allergic reaction to vaccine components or anaphylaxis in the past. 12) Subjects who have received any other licensed vaccines for other indications within 28 days prior to the 3rd dose, or who are planning to receive any other vaccine up to 14 days after the 3rd dose of the mRNA anti-SARS-CoV-2 vaccine (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable.

2

INSTITUT JULES BORDET

18

100

Belgium

High risk patients

N/A

245

The proportion of subjects that have detectable titers of specific antibody against SARS-CoV-2 spike protein, measured by Elecsys® Anti-SARS-CoV-2 S, at 6 months (+/- 4 weeks) after the 2nd dose of a mRNA anti-SARS-CoV-2 vaccine.

TODO

Phase 4

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