Personalized Cancer Vaccines: Watching For Immune-Related, Vaccine AEs

Personalized cancer vaccines can lead to adverse effects (AEs) associated with both vaccines and other immunotherapy strategies, explained David A. Braun, MD, PhD, at the 2025 Kidney Cancer Research Summit.

In an interview with Oncology Nursing News, Braun, who presented data from a phase 1 trial (NCT02950766) regarding the use of a neoantigen-targeting personalized cancer vaccine in patients with renal cell carcinoma, highlighted that a number of immune-related symptoms can occur following vaccination.¹ For instance, flu-like symptoms should be monitored for and treated with acetaminophen.

Additionally, he compared the safety profile of the vaccine to those of what he called “standard immunotherapies,” like pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).

Braun is an assistant professor at Yale School of Medicine and principal investigator in the Center of Molecular and Cellular Oncology within the Yale Cancer Center.

Transcript

Like all immune therapies, the chance of activating or turning on the immune system exists, and that’s something that people must be on the lookout for. Our hope is that that will be diminished compared with classic immune checkpoint inhibitors because of the specificity of a vaccine. But particularly with any early-phase trial and specifically early-phase immunotherapy trial, we must be cognizant.

What immune-related AEs could come from this therapy? There are common things that happen with a vaccine. People not unfrequently get local irritation at the site of a vaccine injection. That’s common. It should be monitored. People often get 1 or 2 days of flu-like symptoms, and some of those can be pretty substantial. People can have bad myalgias, and a fever up to 102 °F. That [fever] needs to be both counseled with anticipatory guidance such as taking [acetaminophen], but also, if people are quite sick and getting dehydrated, that has to be appropriately managed.

Finally, all the other toxicities that can happen with pembrolizumab, nivolumab, and ipilimumab—standard immunotherapies—we still have to [monitor for], because this is the early stage [of personalized cancer vaccines]. We must be on the lookout for those as well: both the things that we may be more comfortable or familiar with from standard therapies, but a couple of additional things that are specific to the vaccine.

This transcript has been edited for clarity and conciseness.

Reference

Braun DA, Moranzoni G, Chea V, et al. A neoantigen vaccine generates antitumour immunity in renal cell carcinoma. Nature. 2025;638:474-482. doi:10.1038/s41586-024-08507-5