A new therapeutic vaccine has great potential to treat precancerous neck lesions, offering hope for non-surgical alternatives to current treatments. In a Phase II clinical trial at the University Medical Center Groningen in the Netherlands, the vaccine, known as VVAX001, was 50% successful 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. Dr. Refika Yigit, the trial’s principal investigator, said these lesions represented a critical medical problem.
“Almost all cervical lesions and cervical cancers are caused by HPV infection, with HPV16 involved in the majority of cases,” said Dr. Yigit. “If left untreated, approximately one-third of CIN3 cases develop cervical cancer within 10 years, About half in 30 years.”
The trial involved 18 HPV16-positive CIN3 patients who received three doses of VVAX001 over nine weeks. Nine patients would have significant regression of their lesions – six to low-grade dysplasia and three showing complete regression with no evidence of dysplasia. Notably, all but one patient experienced a reduction in lesion size, with significant reductions occurring within one month of completion of 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 infected cells while sparing healthy tissue.
Perhaps most importantly, the treatment cleared underlying HPV16 infection in ten of the 16 evaluable patients. This clearance rate is particularly noteworthy because persistent HPV infection is a key factor in disease recurrence.
Of the nine patients whose lesions did not resolve completely and underwent standard surgical treatment, four showed no residual disease in the removed tissue. This finding suggests that in these cases, extended observation after vaccination may allow the elimination of total lesions.
Treatment was good and no serious adverse events were reported. Side effects are usually mild and include injection site reactions and temporary fatigue. This safety profile is in contrast to the current standard treatment (surgical excision), which may lead to complications affecting future pregnancies.
“If confirmed in larger trials, our results could mean that at least half of CIN3 patients may be able to skip surgery and avoid all its possible side effects and complications,” Dr. Yigit explained.
These findings are particularly promising given the limitations of current treatments. Standard surgical procedures, while effective, can increase the risk of pregnancy complications and may affect fertility. For women of childbearing age who wish to preserve their reproductive health, a nonsurgical option may be particularly valuable.
After a median follow-up of 20 months, patients without treatment experienced disease recurrence, suggesting the vaccine may provide durable protection. However, the researchers noted that larger studies with longer follow-up periods are needed to confirm these preliminary findings.
This study was supported by the Netherlands Cancer Society and Vesniwax, although Dr. Yigit reported no conflicts of interest. As research continues, this therapeutic vaccine may represent a major advance in treating HPV-related cervical lesions, which could change the standard of care for the thousands of women diagnosed with precancerous cervical disease each year.
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