Q&A – Study Startup Success for the New Generation of Genetically Engineered Vaccines
In a recent webinar, Advarra Executive Director of Biosafety Services Daniel Eisenman discussed the latest trends in genetically modified vaccine and immunotherapy studies. He also explored unique startup challenges for studies involving investigational products that contain engineered genetic materials. Due to time constraints he wasn’t able to answer all audience questions during the Q&A period, so he has answered some of the most popular questions in this blog.
Q: Do genetically modified vaccines have the same positive effects on diverse racial populations?
A: We can’t tell at this time. Larger Phase III and IV studies are required to incorporate sufficient participant numbers to know for sure. In theory the efficacy should be comparable between different demographic groups, such as ethnicities, but further study is required to know for sure.
Q: What are the differences in efficacy and safety endpoints with the various methods used (e.g., mRNA, viral vector, DNA, etc.)?
A: COVID-19 vaccines with a diverse range of design strategies are currently undergoing clinical trials. Phase III clinical trials must be completed to compare efficacies across the different types of vaccines.
Q: How long is the current monitoring requirement for vaccines in trial that may cause cancer?
A: The FDA recommends long-term follow-up for integrating vectors. This longer-term follow-up can run as long as 15 years. However, none of the vaccines researched so far utilize integrating vectors.
Q: Is there a risk of Guillain-Barre syndrome (GBS) with any of the COVID-19 vaccines in development?
A: Any vaccine poses a theoretical risk of GBS. Clinical trials are necessary to determine the likelihood of such risks. Certain individuals may also be more prone to GBS and may be excluded from vaccine studies.
Q: For mRNA based vaccines, how long does protein expression persist? A few weeks, a few months, years?
A: Protein expression is on the range of a few hours to a few days.
Q: Would the role of a central IBC be a complement to a local IBC?
A: Central IBCs offer the same advantages to institutions as central IRBs. Central IBCs meet much more frequently than local committees, and they often have access to a worldwide network of experts as needed to review the science. Therefore, adding an external central IBC may help an institution activate studies faster, particularly for industry-sponsored research involving human participants, and give the institution a competitive edge to attract more research in the future. Additionally, as some local IBCs may not have much experience reviewing clinical research, a central IBC can augment the local IBC’s expertise and ensure robust, appropriate protections for a given study.
For more information on research involving genetically engineered vaccines and strategies to overcome startup hurdles, watch the webinar Study Startup Success for the New Generation of Genetically Engineered Vaccines.