Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

Inclusion Criteria

• •Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
• •Patients must have one or more of the following risk factors \[CDC 2019\] for a severe COVID-19 infection:
• •* Age \> 65 years old
• •* Hypertension (on medications);
• •* Type 1 or 2 Diabetes (on medication)
• •* A relevant chronic condition as per the investigator based on the medical record, including:
• •* heart (e.g. heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
• •* lung (e.g. chronic obstructive pulmonary disease (COPD including emphysema and chronic bronchitis), moderate to severe asthma, idiopathic pulmonary fibrosis and cystic fibrosis)
• •* liver cirrhosis
• •* serious kidney disease requiring dialysis
• •* Receiving systemic therapy (such as cytotoxic chemotherapy, immunotherapy or targeted agents excluding single-agent hormonal therapy)
• •* Body Mass Index \> 40
• •* Living in a nursing home or long term care facility
• •Patient must have a life expectancy of \>6 months as assessed by the investigator
• •Patient must have an ECOG Performance Status ≤ 2
• •Patient has adequate organ function appropriate for the therapy the patient is planned to receive in the opinion of the investigator and based on local assessment and practices.
• •Patient is aged ≥ 18 years
• •Patient has agreed to receive pneumococcal vaccination and a seasonal influenza vaccination in accordance with Canadian Guidelines.
• •Patient is able (i.e. sufficiently fluent) and willing to complete the health utility questionnaires in either English or French.
• •Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• •Patient must be willing to provide identifying information including provincial health insurance number to facilitate data linkage and follow up.
• •Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• •Women/men of childbearing potential must have agreed to use a highly effective contraceptive method throughout the treatment period and for at least 3 months after discontinuation of treatment.