Controlled Human Infection Model (CHIM) Studies in a Clinical Trial

Controlled human infection model (CHIM) studies are conducted in a clinical trial setting to evaluate the safety and efficacy of new medical products, such as vaccines, drugs, and diagnostics. In these studies, healthy volunteers are deliberately infected with a pathogen so that researchers can track the progression of the disease and measure the effectiveness of potential treatments.?

CHIM studies have been used for over a century to study diseases like influenza, malaria, cholera, and yellow fever, CHIM studies have been used to study infectious diseases like SARS, MERS, and Ebola.?

The first step in a CHIM study is to identify a group of healthy volunteers who are willing to be infected with the pathogen. The volunteers must be carefully screened to make sure they are physically and mentally fit for the study. They must also sign informed consent forms that explain the risks and benefits of participating in the study.?

As the group of volunteers is recruited, researchers will work to infect them with the pathogen. This is usually done by exposing them to the pathogen through close contact with an infected individual, or by injecting them with a solution that contains the pathogen.?

Once the volunteers have been infected, researchers will closely monitor their health for several weeks or months. They will track the progression of the disease and measure any changes in symptoms. They may also administer potential interventions during the infective period to see if they are effective at preventing or treating the disease.?

How is the Controlled Human Infection Model used in a clinical trial??

The Controlled Human Infection Model (CHIM) is a new way to test potential treatments for infectious diseases. In this model, volunteers are infected with a pathogen, such as the flu virus, under controlled conditions. This allows researchers to study the safety and efficacy of potential treatments in a real-world setting.?

The CHIM model has already been used to study several potential treatments for influenza, including a vaccine that is currently in clinical trials. This model is expected to be useful for studying other infectious diseases, such as Ebola and Zika.?

What are the benefits of the Controlled Human Infection Model??

There are several benefits of the Controlled Human Infection Model.??

Following are the benefits compared to a highly regulated randomized controlled trial

1. Shortened duration of trial – saves time and funds.?
2. ?This model allows researchers to study the safety and efficacy of potential treatments in a real-world setting. This helps in establishing the product at a faster rate in the market.?
3. In addition, this model can be used to study the transmission of infectious diseases and to develop new outbreak control strategies.?

How to implement the Controlled Human Infection Model in a clinical trial??

The CHIM model is implemented with a two-pronged strategy of –?

1. Controlling the development and administration of pathogen: the well-characterized strain of pathogen is simulated and a controlled dose is given to the volunteers.?
2. Continuous data monitoring and speedy processing: The vital outcome measures of the volunteers are continuously tracked and periodic sampling from them, helps in faster processing of drugs and taking care of any discrepancies in their quality.?

Conclusion?

CHIM is a powerful tool that can be used to improve the efficacy of clinical trials. However, it is important to remember that this model should only be used in a controlled setting, as there is always the potential for serious health complications. For more information, please refer Human Challenge Studies Section of - https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Guidance-for-Industry--General-Principles-for-the-Development-of-Vaccines-to-Protect-Against-Global-Infectious-Diseases.pdf?