Accelagen leads clinical trial for mRNA COVID-19 vaccine designed for immunosuppressed patients

With immunosuppressed patients left behind by existing COVID-19 vaccines, innovative biotech HelixNano has partnered with Accelagen to test the next generation of mRNA vaccines. This collaboration demonstrates the essential role of clinical research in safeguarding the most vulnerable communities from the continuing effects of COVID-19.

The development of safe and effective vaccines was a major scientific achievement which allowed the global community to manage the COVID-19 pandemic, but challenges remain - especially for immunosuppressed patients who often don’t respond as well to vaccines currently in circulation.

To address this gap, Massachusetts-based biotech firm HelixNano has partnered with leading Clinical Research Organisation (CRO) Accelagen to test the next generation of mRNA vaccines. Unlike existing COVID-19 vaccines, this novel prophylactic is specifically designed to enhance the immune response to the virus in immunosuppressed patients.

The Phase I clinical trial is being conducted at the University of the Sunshine Coast (UniSC) in Queensland, Australia, where Accelagen’s Clinical Research Associates (CRAs) team managed logistics and monitoring of the trial closely. Accelagen’s expertise in trial management, site selection, and regulatory navigation has been instrumental in driving the study forward and ensuring the effective evaluation of this novel mRNA vaccine for COVID-19.

The trial’s progress has been impressive, particularly in terms of patient recruitment. Despite the known challenges of enrolling participants in a competitive landscape, the project successfully exceeded its recruitment targets, a testament to the team’s diligence and Accelagen’s strategic oversight. Accelagen and UniSC not only met the trial’s original target of 60 participants but also recruited an additional 8 volunteers following a protocol amendment - an exceptional achievement in clinical research.

Accelagen’s logistical trial management also ensured that patients consistently attended visits, a crucial factor in maintaining a clinical trial’s momentum. While sponsors often focus on final outcomes, Accelagen’s role in the day-to-day execution helped bridge the gap between laboratory research and clinical translation.

Accelagen’s involvement in this trial started during the study’s startup phase where our local CRA was responsible for setting up the site, initiating trial procedures, and monitoring the progress of the trial. The decision to conduct the trial at UniSC was based on an in-depth site selection process considering factors like patient accessibility, research infrastructure, and the site’s history of clinical trials.

"Working with the Sunshine Coast site has been key to the success of the trial. Our established relationship with them and knowledge of their high work standard, was central to make sure everything ran smoothly from start to finish." Accelagen explains.

Trusted relationships with trial sites enable faster recruitment, tighter protocol compliance, and streamlined operations. Effective collaboration between CROs and sites is critical, and Accelagen’s hands-on engagement aligns all stakeholders toward the common goal of conducting efficient, high-quality clinical research.

Accelagen is looking ahead to the future with plans to support HelixNano initiating further clinical trials in Australia focused on recruiting patients in a target population with renal failure. The trial will aim to evaluate the safety and efficacy of the vaccine in a patient population that is often difficult to engage due to the complexities of the condition. By combining their knowledge and experience with HelixNano's innovative approach, Accelagen is poised to contribute meaningful advancements in the development of this novel vaccine for the prevention of COVID-19 in immunosuppressed patients.

This innovative COVID-19 mRNA vaccine trial highlights the critical factors that contribute to successful clinical research - strategic site selection, proactive trial management, and strong sponsor-site relationships. As the study moves into its next phase, the lessons learned from this collaboration will continue to shape the future of vaccine development for vulnerable populations.

With a proven history of managing complex clinical trials, Accelagen is well positioned to support biotech companies in bringing groundbreaking therapies to market. Their ability to navigate logistical challenges, ensure regulatory compliance, and optimise trial efficiency makes them an invaluable partner in the global clinical research landscape.

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