Site Insights: RSV Vaccine

According to the CDC, RSV (Respiratory Syncytial Virus) leads to over 200k hospitalizations and approximately 14k deaths in the US each year. This disease, which occurs primarily during the fall, winter, and spring, typically impacts children younger than 5 years old and adults 65 years and older. This March, the CDC detected increased rates of RSV in the United States, Australia, and South Africa. With cases on the rise, the need for an effective RSV vaccine is rapidly increasing.

Developing and testing new vaccines is a uniquely complex process, typically involving thousands of participants across the globe. This requires an especially high level of coordination among different sites to ensure all populations are represented. Seasonal diseases like RSV only further complicate this, requiring sponsors to think about which countries will be facing the disease at what times, and properly aligning their study timelines.

With this increased complexity, it’s critical to get early feedback. Speaking with global sites before a trial begins allows sponsors to understand how they will meet certain protocols and timelines, whether their estimated number of participants is realistic and achievable, and allows sponsors to better plan for the barriers sites will face in different countries. Last month, Inato spoke with 13 research sites around the world to gather information on their capabilities to perform in an RSV vaccine trial.

The sites brought unique and impressive experiences in both RSV and other vaccine trials. One site in Argentina conducted a recent vaccine trial where they were able to recruit 1,900 participants in just three months. A research center in South Africa completed one RSV study where they surpassed the enrollment goal and is about to begin another one. A site based in Colombia not only just completed two RSV trials, but also has remarkable broader experience with 75% of their total trials being in vaccines.

Overall, 63% of the sites we talked to had previous RSV experience and 94% had experience in vaccine trials.

In each conversation, the sites shared the number of participants they realistically could enroll over a given amount of time. In addition, they presented robust recruitment plans and shared details around why they were optimistic about bringing in a large number of participants. A research center in Canada projected a total of 500 participants over 8 months and one in the Ukraine estimated around 40 per month, gauging that they could bring in a total of 300 participants. One site in Germany determined that they would be capable of enrolling 1,000 participants!

Across all the interviews, we found that 68% of the sites we talked to are capable of recruiting over 100 participants; of those sites 75% are able to recruit over 500 participants.

Beyond the enrollment numbers and experience, it’s critical for sponsors to understand the communities that sites serve to ensure the trial includes the correct diversity targets based on that disease. With data representing a diverse group of participants, sponsors will be able to confidently report that the vaccine is tested and safe for the entire affected population.

One research center in South Africa had multiple sites where they were able to recruit native South African participants. Another site in South Dakota shared that their participant population is 90% Native American, a critical target population for RSV.

When speaking with these research locations, we were able to learn more about the communities they work in and care so deeply about providing with the latest clinical research. Such conversations allow our team to form relationships with the site personnel that go beyond the numbers and past research experience. Having personalized conversations and gaining deeper insights about what makes each site unique is an invaluable part of the process, yet it is so often overlooked. By completing this step, Inato allows sponsors to move forward with trials confident that they are bringing research opportunities to qualified and passionate communities.

At Inato, we strive to help sponsors diversify their patient pool by connecting them to qualified sites with untapped potential. We envision a future where involving community sites with global trials is the industry standard, ensuring that clinical research is diverse and accessible.