Developing protective vaccines for endemic and emerging infectious diseases is a top priority for global health and a promising area for innovation with decentralized clinical trials (DCTs). A DCT is a trial where some or all research activities occur at locations other than a traditional clinical trial site. These activities often include digital screening, remote enrollment, and remote participant monitoring.
The response to the COVID-19 pandemic included the rollout of a variety of innovative hybrid approaches to vaccine trials. As one example, participants were able to collect dried blood spots in the home setting for immune monitoring and to determine the development of vaccine-induced antiviral antibodies. The potential for remote monitoring for the efficacy of infection and safety events has been clearly demonstrated, and these approaches will play more prominent roles in the coming years.
An emerging area under consideration is direct-to-participant investigational product delivery. With the ongoing development of oral, intranasal, and microneedle array patch vaccine delivery systems, at-home vaccine self-administration is becoming more plausible. The FDA is currently considering allowing at-home self-administration of an approved intranasal live attenuated influenza vaccine. However, for investigational products, significant concerns related to safety, shipment, stability, privacy, blinding, and compliance create barriers to the rapid adoption of comprehensive direct-to-participant vaccine testing approaches.
Many of the most promising new vaccine technologies involve genetically modified products such as recombinant or synthetic mRNA or DNA, or viral and bacterial vectors. In the U.S., Institutional Biosafety Committees (IBCs) usually oversee the safe handling, administration, and disposal of genetically modified investigational vaccines. IBCs are traditionally based at research institutions and fixed clinical trial sites, and IBC approval requires assessment of facilities, equipment, and procedures at each site.
One solution to the limitations outlined above is the use of mobile research units. Mobile facilities housed in vans and trailers can bring research capabilities closer to the participants while allowing for careful management of product handling, safety, and privacy concerns. Importantly, with appropriate documentation and advanced planning, mobile research units can be reviewed and approved by an IBC, bringing cutting-edge research to neighborhoods and community settings.
Regarding pandemic preparedness, flexible and adaptable clinical trial platforms will be critical for an agile and timely response to the next emergency. Increasing decentralization of vaccine trials in 2024 and beyond will play a key role in enabling that flexibility.
