COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
This trial aims to measure the humoral and adaptive immune response in patients with cancer diagnosis undergoing mRNA vaccination against SARS-CoV-2 and assess its efficacy in preventing COVID-19.

Official Title
-----------------
COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Biological: Spikevax
* Biological: Comirnaty
* Biological: Spikevax bivalent Original/Omicron BA.1
* Biological: Spikevax bivalent Original/Omicron BA.4-5
* Biological: Comirnaty Original/Omicron BA.1
* Biological: Comirnaty Original/Omicron BA.4-5
* Biological: Comirnaty Omicron XBB.1.5
* Biological: Spikevax Omicron XBB.1.5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old ECOG performance status ≤ 2 Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy) undergoing active systemic cancer treatment at the time of the last dose (before ICF signature) of the anti-SARS-CoV-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in non-metastatic/curative setting or in metastatic/palliative setting or undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of the last dose (before ICF signature ) of the anti-SARS-CoV-2 mRNA vaccine. Life expectancy > 6 months Subjects who received at least 2 doses of mRNA platform vaccination against SARS-CoV-2 as per local guidelines, with the last dose being given between 3 and 12 months prior to baseline assessment. Urine/serum pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment. Signed Informed Consent form (ICF) obtained prior to any study related procedure Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations. Exclusion Criteria: Known pregnant and/or lactating women. 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. Subjects with active diagnosis of acute leukaemia. Subjects treated with bone marrow transplant < 90 days before received vaccination against SARS-CoV-2. Subjects with a known history of HIV infection. COVID-19 infection in the last 28 days prior to subject enrolment. 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. Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA vaccine. Subjects that received the 3rd dose of anti-SARS-CoV-2 mRNA vaccine prior to study entry. Exclusion criterion number 9 is only applicable for previous versions of the protocol and is not applicable from protocol version 3.0 and subsequent versions. Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform. Subject 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. Subjects who planned to receive any other licensed vaccines for other indications within 28 days prior to the first booster dose after ICF signature or who are planning to receive any other vaccine up to 14 days after the first booster dose of the mRNA anti-SARS-CoV-2 vaccine after ICF signature (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable. Subjects who have planned to receive a booster dose after ICF signature but before the baseline assessment Subjects who received COVID-19 pre-exposure prophylactic monoclonal antibodies or who have been treated with anti-SARS-CoV-2 monoclonal antibodies or COVID-19 convalescent plasma during the last 6 months before ICF signature.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Spikevax|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Comirnaty|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Spikevax bivalent Original/Omicron BA.1|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Spikevax bivalent Original/Omicron BA.4-5|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Comirnaty Original/Omicron BA.1|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Comirnaty Original/Omicron BA.4-5|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Comirnaty Omicron XBB.1.5|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|
|Biological: Spikevax Omicron XBB.1.5|Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immune response against SARS-CoV-2 after the last dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment) | Rate of humoral immune response against SARS-CoV-2 between 3 and 12 months after the last dose (before ICF signature) of a mRNA anti-SARS-CoV-2 vaccine (baseline assessment) | 3 to 12 months after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immune response against SARS-COV-2 | Duration of humoral immune response against SARS-COV-2 based on the final study assessment, namely at 6 months (+ /- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster dose after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines. | at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines. | 
| Humoral immune response against SARS-COV-2 by cohort | Rate of humoral immune response against SARS-COV-2 by cohort | 3 to 12 months after the last dose before ICF signature; and 6 months (+/- 4 wks) after baseline assessment or 6 months (+ 4 wks/-8 wks) after the first booster after ICF signature if a booster dose is administered during the study | 
| Rate of asymptomatic subjects with SARS-CoV-2 positive test during the study | Rate of asymptomatic subjects with SARS-CoV-2 positive test, confirmed COVID-19 or severe COVID-19 infection with onset at least 14 days after the last dose before ICF signature in subjects who had been without serologic or virological evidence of SARS-CoV-2 infection up to 14 days after the last dose before ICF signature. | Retrospectively collected at each visit: at baseline assessment, pre-boosting (within 2 wks before 1st booster dose after ICF signature), post-boosting (2 wks after this booster); and 6 months after this booster OR after baseline assessment if no booster | 
| Safety of booster dose(s) of mRNA anti-SARS-CoV-2 vaccine received after ICF signature | Frequency, duration and severity of adverse reactions reported according to NCI Common Terminology Criteria for Adverse Events signature (CTCAE) Version 5.0, if booster dose(s) of the vaccine are administered during the study per local / national health policy guidelines. | During the 30 days following the administration of the booster received during the study period (if any) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mRNA, COVID-19, COVID19, immunity, vaccination, SARS-CoV-2, Spikevax, Comirnaty, Omicron