A new therapeutic vaccine has demonstrated significant potential in treating precancerous cervical lesions, offering hope for a non-surgical alternative to current treatments. In a phase II clinical trial conducted at the University Medical Centre Groningen in the Netherlands, the vaccine, known as Vvax001, showed a 50% success rate in clearing high-grade cervical lesions.
The study, published in Clinical Cancer Research, focused on treating cervical intraepithelial neoplasia grade 3 (CIN3), a serious precursor to cervical cancer. According to Dr. Refika Yigit, the trial’s principal investigator, these lesions represent a critical medical concern.
“Nearly all premalignant cervical lesions and cervical cancers are caused by HPV infection, with HPV16 implicated in the majority of cases,” said Dr. Yigit. “If left untreated, approximately one-third of CIN3 cases progress to cervical cancer within 10 years and roughly half within 30 years.”
The trial involved 18 patients with HPV16-positive CIN3 who received three doses of Vvax001 over a nine-week period. Nine patients experienced significant regression of their lesions—six to low-grade dysplasia and three showing complete regression with no signs of dysplasia. Notably, lesion size was reduced in all but one patient, with reductions evident within a month of completing vaccination.
The vaccine’s mechanism relies on a modified version of the Semliki Forest virus that cannot replicate but produces specific proteins found exclusively in HPV16-infected cells. This targeted approach appears to trigger the body’s immune response against the infected cells while sparing healthy tissue.
Perhaps most significantly, the treatment cleared the underlying HPV16 infection in ten of sixteen evaluable patients. This clearance rate is particularly noteworthy as persistent HPV infection is a key factor in disease recurrence.
Among the nine patients whose lesions did not completely regress and who underwent standard surgical treatment, four showed no residual disease in the removed tissue. This finding suggests that extended observation after vaccination might have allowed for full lesion elimination in these cases.
The treatment was well-tolerated, with no serious adverse events reported. Side effects were generally mild and included injection site reactions and temporary fatigue. This safety profile stands in contrast to the current standard treatment—surgical excision—which can lead to complications affecting future pregnancies.
“If confirmed in a larger trial, our results could mean that at least half of the patients with CIN3 might be able to omit surgery and avoid all its possible side effects and complications,” Dr. Yigit explained.
The findings are particularly promising given the limitations of current treatments. Standard surgical procedures, while effective, can increase the risk of pregnancy complications and may impact fertility. A non-surgical option could be especially valuable for women of childbearing age who wish to preserve their reproductive health.
After a median follow-up of 20 months, none of the treated patients has experienced disease recurrence, suggesting the vaccine may provide lasting protection. However, researchers note that larger studies with longer follow-up periods will be needed to confirm these initial findings.
The study was supported by the Dutch Cancer Society and ViciniVax, though Dr. Yigit reported no conflicts of interest. As research continues, this therapeutic vaccine could represent a significant advancement in the treatment of HPV-related cervical lesions, potentially changing the standard of care for thousands of women diagnosed with precancerous cervical conditions each year.