Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
NCT ID: NCT04442048
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2020-10-01
2025-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMM-101
The treatment regimen with IMM-101 will be one 1.0 mg (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg (= 0.05 mL) on Day 45 (+/-14 days)
IMM-101
Three doses of IMM-101 on days 0, 14, and 45.
Observation
Observation
No active treatment. Observation only
Interventions
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IMM-101
Three doses of IMM-101 on days 0, 14, and 45.
Observation
No active treatment. Observation only
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patient cannot have either at present or in the past, a positive test for COVID-19 infection. If a patient has been tested for COVID-19, result must be confirmed as negative prior to enrollment.
* Patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production.
* Patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment.
* Patient has any co-existing active infection that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
* Patient has previously experienced an allergic reaction to any mycobacterial product, including the BCG vaccine.
* Patients with superficial bladder cancer or any other condition currently receiving or planned to be treated with BCG.
* Patient has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or a known history of or is known to have a positive test for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA \[qualitative\]).
* Patients with prior or concurrent leukemia.
* Patient has had a prior bone marrow transplant.
* Patient is pregnant or breast-feeding
* Patient has documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. This includes patient requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed.
18 Years
ALL
No
Sponsors
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Immodulon Therapeutics Ltd
INDUSTRY
BioCan Rx
UNKNOWN
Canadian Cancer Society (CCS)
OTHER
ATGen Canada Inc
INDUSTRY
Canadian Centre for Applied Research in Cancer Control (ARCC)
UNKNOWN
Ontario Institute for Cancer Research
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Rebecca A Auer
Role: STUDY_CHAIR
Ottawa Hospital Research Institute
Locations
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Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Research Institute of the McGill University
Montreal, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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IC8
Identifier Type: -
Identifier Source: org_study_id