Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving...

Area of Science:

• Infectious Diseases
• Clinical Trial Methodology
• Vaccinology

Background:

• Emerging infectious diseases necessitate rapid patient protection strategies.
• Immunobridging is a trial methodology using immunological markers as surrogate efficacy measures.
• This approach facilitates swift access to vaccines and novel drugs.

Purpose of the Study:

• To explore the concepts, advantages, and challenges of immunobridging trials.
• To enhance awareness of immunobridging among clinicians, patient groups, regulators, and health leaders.
• To ensure broader patient protection against current and future infectious disease threats.

Main Methods:

• Review of immunobridging trial methodology.
• Analysis of its application in authorizing drugs, including COVID-19 vaccines.
• Discussion of opportunities and issues related to immunobridging.

Main Results:

• Immunobridging enables inference of vaccine effectiveness via surrogate immunological markers.
• The methodology has been utilized for authorizing novel therapeutics, including COVID-19 vaccines.
• It offers a pathway for expedited vaccine approval and deployment.

Conclusions:

• Immunobridging trials are crucial for safeguarding patients from emerging infectious diseases.
• Increased understanding of immunobridging can reduce protection gaps for major pathogens.
• This methodology supports timely patient access to essential vaccines and treatments.