World Immunization Week is part of a global health campaign to raise awareness and increase immunization against diseases that can be prevented by vaccines. Can you discuss some of the promising new developments in the vaccine pipeline?
Interestingly enough, prior to the COVID pandemic, vaccine development was on an upward trajectory, as new adjuvanted cell-based vaccines have been recently approved, along with quadrivalent for flu, and indications such as RSV and Ebola, among others, were emerging targets. Vaccine R&D was disrupted and accelerated with mRNA technologies which were driven by global need due to COVID-19. While the rapid development, production, and scalability of mRNA vaccine technology were unprecedented, it is just the first of many generational changing vaccine technologies, in my opinion.
Next-gen mRNA, or self-amplifying RNA, or any of the main differentiated vaccine technologies gaining traction, coupled with different adjuvants or delivery systems (intranasal, inhaled, oral, sub-lingual, and micro-needle patches) are at the tipping point of discovery and development. We are going to see combination vaccines and flexible combination methods of delivery, which will require collaboration across global pharmaceutical companies, niche biotechs, and support from global health organizations, governments, and foundations.
Trial results involving mRNA vaccines have been making headlines recently. Can you summarize some of the potential breakthrough treatments taking shape in this space?
COVID-19 has been closely followed by vaccines for Flu, RSV, CMV, EBV, HSV, HSV, HIV, Lyme Disease, Zika, Monkeypox, and more. The number of potential applications both for prophylactic mRNA vaccines and soon, therapeutic mRNA vaccines may not have any limiting boundaries. At this point, many efforts will be focused on improving products with respect to distribution, reducing side effects, improving safety, and, most importantly, enhancing durability. As a key example, the current mRNA strategy for COVID-19 requires continuous review and development (much like annual influenza) as variants of concern emerge. Protection wanes quickly, and there is the potential for people to develop “vaccine fatigue.” More durable vaccines which can offer protection over longer periods of time – through one vaccine administration with improved T-cell responses are critical. And the “holy grail” of vaccine development — the pursuit of a universal flu vaccine, is ongoing.
The conduct of vaccine trials is different than other therapeutic areas. It is often fast and, at times, very reactionary. The potential volume within condensed periods of time can be particularly demanding compared to other trial types. Challenges frequently arise due to the variables that we don’t control, such as investigational product manufacturing and shipment, regulatory delays or obstacles, supply chain disruptions, technology integration, and trial-specific training. Essentially other parties have to do their part before we can effectively execute our part of the research process. Nothing is necessarily complicated about conducting and executing clinical trials, but it can be complex if you understand the distinction.
Successful trial execution is rooted in disciplined approaches, especially in the study start-up process, data collection, safety assessment, and of course, sound project management to deftly coordinate all the moving parts. The overarching requirement from a clinical research staff perspective is to understand our primary customers are the sponsor of the study and the volunteers who participate in the study.
How did Coastal Carolina get involved in vaccine research, and what contributed to the depth of experience in vaccine trials?
Persistence paid off in 2006 when a large vaccine maker awarded two Phase 1 cell-based seasonal flu vaccine trials. We had a successful FDA audit resulting from those first two vaccine trials, and it just continued to grow. Our principal investigator has always been a strong advocate for vaccine development. Once we had the experience and continued to nurture our relationships with both large and small pharma and biotech organizations, it continued to grow to the point where now we have conducted more than 120 vaccine trials over the past 16+ years.
What do you see as the greatest opportunities to broaden vaccine research participation to more diverse populations?
Often the most impacted groups among diseases and infections that vaccines can help prevent are minority communities or who are often underrepresented in the overall participation in clinical trials. While Coastal Carolina Research Center has taken steps such as:
a) Physically moving our research site to an area more accessible to such underrepresented communities and
b) Expanding our operational hours to both extended weekday hours and Sundays, which allows access and flexibility for all volunteers in the community to participate, we need to constantly evolve the ways we respectfully engage diverse populations and increase the frequency.
Continual efforts to build advocacy from respected community leaders are important. Medical research is generally received with a high recognition of importance. However, if you individualize it and ask the nuanced question, “How important is medical research to you specifically” and “How much do you know about medical research,” the responses are less precise. It is this area in which we must collectively (the entire clinical research community) just simply must do better. The goal is to move the needle and improve health outcomes and quality of life, especially in populations where it can potentially have the biggest impact.
Nathan Morton
Business Development, Alcanza Clinical Research
