Vigil Vaccine for Ovarian Cancer

(VITAL Trial)

This trial aims to determine if a treatment called Vigil can delay the return of ovarian, fallopian tube, or primary peritoneal cancer. Participants will receive either Vigil, a type of immunotherapy that uses the body's immune system to fight cancer, or a placebo, which has no active therapeutic effect. The study seeks women who have undergone successful surgery and chemotherapy for advanced stages of these cancers and are currently disease-free. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy or chronic steroids, you may need to stop them before joining the trial.

Research has shown that Vigil immunotherapy is generally easy for patients to handle. In one study, seven patients experienced serious health issues, but none were directly caused by the treatment. This indicates that while side effects can occur, they are neither common nor severe. Another study found that Vigil was well-tolerated by patients with advanced ovarian cancer. Importantly, no deaths related to the treatment were reported, offering reassurance to those considering joining a trial.¹²³⁴⁵

Unlike the standard treatments for ovarian cancer, which often include chemotherapy and surgery, the Vigil vaccine is unique because it harnesses the body's immune system to fight cancer. It works as an immunotherapy, aiming to train the immune system to recognize and destroy cancer cells more effectively. Researchers are particularly excited about Vigil because it could offer a more targeted approach, potentially leading to fewer side effects and enhanced long-term outcomes compared to conventional therapies. Plus, its administration through intradermal injection every four weeks provides a straightforward and potentially more convenient treatment regimen.

In this trial, participants will receive either Vigil immunotherapy or a placebo. Studies have shown that Vigil immunotherapy can effectively treat ovarian cancer. Research indicates that it can significantly improve overall survival and delay cancer recurrence, particularly in patients with advanced ovarian cancer who lack the BRCA gene mutation. One study found that Vigil was well tolerated and benefited patients with specific genetic profiles, such as those without the BRCA mutation and those with normal DNA repair function. Another study found that patients receiving Vigil experienced an average of 8.2 months before cancer worsened and lived an average of 18.5 months overall. These findings suggest that Vigil may help delay cancer recurrence and improve survival in certain ovarian cancer patients.¹²³⁶⁷