The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections. Laboratory tests show that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, so that if you are exposed to these types of infections your body may be able fight off the infection better. That could help prevent severe symptoms from respiratory and COVID-19 related infections. It has been studied in over 300 cancer patients who have also been receiving other cancer treatments, including chemotherapy and radiation, and seems promising, but it is not clear if it can offer better results than not having the immunization at all.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
Three doses of IMM-101 on days 0, 14, and 45.
No active treatment. Observation only
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
The rate of "flu-like illness" which includes:
* WHO definition of "influenza-like illness" (ILI) \[Fitzner 2018\] or confirmed viral/bacterial respiratory infection AND * Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
Time frame: 1 year
The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented
Time frame: 1 year
The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death
Time frame: 1 year
The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).
Time frame: 1 year
The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months
Time frame: 3, 6, and 12 months
The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L
Time frame: 1 year
Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death
Time frame: 1 year
Overall survival (OS), as time from enrollment to death from any cause
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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
Time frame: 1 year
Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101
Time frame: 1 year
Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
Time frame: 1 year
Incidence and duration of ICU admission related to documented COVID-19 infection
Time frame: 1 year