Why carry out this study?

Several clinical studies are evaluating the efficacy of vesatolimod as an immunomodulator in combination with other modalities such as broadly neutralizing antibodies and therapeutic vaccines for human immunodeficiency virus (HIV) remission.

As an immunomodulator, flu-like symptoms are known to occur with vesatolimod; therefore, a broader understanding of the safety profile of vesatolimod and its relationship with dose and mechanism of action will help inform future clinical studies.

We conducted a pooled analysis of data on flu-like adverse events in participants who received vesatolimod or placebo in eight clinical trials.

What was learned from the study?

Flu-like adverse events associated with vesatolimod administration were typically mild but increased with exposure and were predicted by the response to initial doses.

Dose-dependent elevations of pharmacodynamic biomarkers observed in participants with flu-like adverse events suggested a link with vesatolimod mechanism of action.

The data suggest that adaptive clinical monitoring could help maximize pharmacodynamic responses and balance adverse events in future clinical trials of vesatolimod in people with HIV.