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A Phase II clinical trial has found that a therapeutic vaccine targeting human papillomavirus (HPV) type 16 (HPV16) can induce regression in high-grade precancerous cervical lesions, offering a potential alternative to surgery. The study, published in Clinical Cancer Research, demonstrated that the vaccine, Vvax001, could reduce or even eliminate precancerous lesions associated with HPV16, the most common strain linked to cervical cancer.
“Nearly all premalignant cervical lesions and cervical cancers are caused by HPV infection, with HPV16 implicated in the majority of cases,” said Refika Yigit, MD, principal investigator and oncological gynecologist at University Medical Center Groningen, the Netherlands.
The trial involved 18 patients with HPV16-positive grade 3 cervical intraepithelial neoplasia (CIN3), a condition where cells are on the verge of becoming cancerous. CIN3 lesions are at high risk of progressing to cervical cancer if left untreated, with up to one-third progressing to cancer within 10 years.
The Vvax001 vaccine, derived from a modified Semliki Forest virus, induces an immune response specifically targeting HPV16-infected cells, which express the oncogenic E6 and E7 proteins. These proteins are central to the development of HPV-associated cancers.
Patients in the trial received three doses of the vaccine, spaced three weeks apart. After 19 weeks, 9 of the 18 participants showed regression of their lesions, with six experiencing a reduction to low-grade dysplasia and three showing complete regression with no signs of dysplasia. Lesion size decreased significantly in all but one of the patients, with noticeable improvements within a month of completing the vaccination.
“To the best of our knowledge, this response rate makes Vvax001 one of the most effective therapeutic vaccines for HPV16-associated CIN3 lesions reported to date,” said Yigit. “If confirmed in a larger trial, our results could mean that at least half of the patients with CIN3 might be able to avoid surgery and its associated risks.”
The vaccine also led to HPV16 clearance in 10 of the 16 patients evaluated, including all nine whose disease regressed. Notably, after a median follow-up of 20 months, none of the patients experienced a recurrence.
However, the trial’s authors caution that further research is needed, as the study had several limitations, including a small sample size and limited follow-up time. Additionally, no control group was used due to ethical considerations.
The results offer hope for an alternative treatment to the standard surgical procedure, loop excision, which can be associated with complications. If further trials confirm these findings, Vvax001 may play a pivotal role in the future of cervical cancer prevention.
For more information, refer to the study titled “Vvax001, a therapeutic vaccine for patients with HPV16-positive high-grade cervical intraepithelial neoplasia: a Phase II trial,” published in Clinical Cancer Research (2025).
Disclaimer: The findings from this clinical trial are based on preliminary data and require further confirmation in larger studies. This study does not replace the advice or treatment recommendations from a medical professional. Always consult a healthcare provider for advice regarding medical conditions and treatments.
