ImmunOptimize Network is a planned clinical trials network to protect those individuals who are at the highest risk of infection, led by the Infectious Disease Sciences Program in the Vaccine and Infectious Diseases Division at Fred Hutch Cancer Center. Learn more about supporting the ImmunOptimize Network through our ongoing fundraising efforts.
Addressing the Infectious Disease Challenges in Immunocompromised Patients
By Sophia Abene
As therapies that impact the immune system become more common, patients are living longer but with increased susceptibility to infections, including viral, bacterial, fungal, and emerging diseases.
Infectious disease experts propose trials network dedicated to immunocompromised patients
ImmunOptimize workshop convened stakeholders across disciplines to brainstorm infectious disease clinical trials network designed to serve people with weakened immune systems
2024 Inaugural Workshop
Thank you to all participants who attended the Inaugural Workshop to develop a network focused on immunotherapeutic approaches to prevent and treat infections in immunocompromised patients on September 10, 2024, in Bethesda, MD!
The Problem
Historically, most vaccines and other infectious disease therapeutics have not been rigorously studied in immunocompromised patients. These patients are often most likely to benefit from these vaccines and therapies.
Immunocompromised individuals are largely excluded from clinical trials. This generates large gaps in clinical understanding of how new vaccines and therapies should be administered to these populations, who are at the highest risk of complications and mortality. This results in delays of months or longer before immunocompromised people can access lifesaving vaccines and therapies.
Immunocompromised people are disproportionately affected by infectious diseases. More than 20 million Americans are immunocompromised, including cancer patients, organ transplant recipients, people with autoimmune disorders, and people with undetected and untreated HIV.
Everyone’s health is connected. Many infectious diseases, like measles, can reemerge in immunocompromised people and then spread to a larger population, resulting in broader public health concerns. Immunocompromised patients may play a critical role in viral evolution when infection goes unchecked, resulting in a potential source of viral variants.
The Solution
Create a national clinical trials network for immunocompromised individuals - where researchers conduct parallel clinical trials for vaccines, monoclonal antibodies, antiviral drugs, and other innovative medicines in these populations in a timely manner and in large enough scale to establish meaningful safety and efficacy standards.
Why This Matters to Patients
This is a neglected but relatively large and rapidly growing population whose quality of life continues to be substantially impacted by SARS-CoV-2 and other infectious diseases. We, as a society, can and should do better to generate the data to guide evidence-based recommendations for immunocompromised patients and their providers.
The COVID-19 pandemic underscored the vulnerability of highly immunocompromised cancer and other patients to new epidemic and existing endemic infectious diseases. This is a major gap in our country’s public health response that left many of these patients feeling isolated and ignored.
Clinical trials in immunocompromised individuals require additional considerations and expertise given they may respond differently and have unique side effect profiles. Although these are highly addressable issues, the activation threshold to include them in trials is higher. Some pharmaceutical manufacturers do not see an opportunity for a return on investment. Government intervention is crucial for major and lasting changes.
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