New HPV vaccine shows promise in treating high-grade cervical lesions

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A new vaccine targeting human papillomavirus type 16 (HPV16) has shown promise in reducing advanced precancerous cervical lesions, according to results from a phase II clinical trial published in Clinical Cancer Research.^1,2

“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, lead researcher and gynecologist at University Medical Centre Groningen in the Netherlands.¹

The trial focused on grade 3 cervical intraepithelial neoplasia (CIN3), a condition where cells show significant precancerous changes. If untreated, about one-third of these cases progress to cervical cancer within 10 years, and nearly half within 30 years, Yigit explained.¹

“The main goal of our trial was to see if our vaccine—Vvax001—could provide an alternative to the standard surgical treatment, which often has complications,” Yigit added.¹

The Vvax001 vaccine is a modified version of a virus that cannot replicate. It produces proteins specific to HPV16-infected cells. Previous research showed that the vaccine triggers strong immune responses against HPV16 proteins.²

In the trial, 18 newly diagnosed HPV16-related CIN3 patients received 3 vaccine doses over 3 weeks. Each dose contained 5x10⁷ infectious particles. They were monitored for up to 19 weeks, with a final examination and biopsy conducted after treatment. Surgery was performed only if CIN2/3 lesions remained.²

The results showed that nine of the 18 patients had improvements—6 had less severe changes in their cervical cells, and 3 had no signs of disease. Most patients saw a reduction in lesion size within a month of finishing treatment, with reductions evident as early as 3 weeks after the last immunization. Among the 9 patients whose disease did not improve, surgery was performed, but no remaining disease was found in four cases, suggesting the vaccine may have worked over time.²

Histopathological analysis revealed a complete response (regression to CIN1 or no dysplasia) in 50% of the patients. Additionally, HPV16 clearance was observed in 10 of the 16 patients tested (63%). However, the vaccine did not clear other HPV types.²

“To our knowledge, this makes Vvax001 one of the most effective vaccines for treating HPV16-related CIN3 reported so far,” Yigit said. “If confirmed in larger studies, our findings suggest that many patients with CIN3 might be able to avoid surgery and its potential complications.”¹

Clearing HPV from the body is linked to a lower chance of the disease coming back. In this study, 10 of the 16 patients tested no longer had HPV16, including all nine whose condition improved. Two patients whose disease did not improve also cleared HPV16, but their lesions were linked to other HPV types. After a median follow-up of 20 months, no patients had a recurrence. The longest disease-free survival time observed was 30 months.²

While the results are encouraging, the study limitations included a small sample size, limited follow-up time, and the lack of a comparison group for natural recovery due to ethical reasons. No serious adverse events related to the treatment were observed.²

The authors concluded that these results represent an important step forward in the fight against HPV-related cervical cancer. Further research is needed to confirm the vaccine’s effectiveness and safety in larger, more diverse groups.²

References:

1. American Association for Cancer Research. A therapeutic HPV vaccine could eliminate precancerous cervical lesions. Eurekalert. January 24, 2025. Accessed January 27, 2025. https://www.eurekalert.org/news-releases/1071497

2. Eerkens AL, Esajas MD, Brummel K, et al. Vvax001, a Therapeutic Vaccine for Patients with HPV16-positive High-grade Cervical Intraepithelial Neoplasia: a Phase II Trial. Clin Cancer Res. Published online January 24, 2025. doi:10.1158/1078-0432.CCR-24-1662