Vvax-001(ViciniVax BV)

THURSDAY, Jan. 30, 2025 -- For patients with human papillomavirus (HPV) type 16 (HPV16)-positive cervical intraepithelial neoplasia grade 3 (CIN3), vaccination with a replication-incompetent Semliki Forest virus vaccine encoding HPV16 E6 and E7 is safe and shows clinical effectiveness, according to a study published online Jan. 24 in Clinical Cancer Research . Anneke L. Eerkens, from the University of Groningen in the Netherlands, and colleagues examined the clinical efficacy of Vvax001 in patients with HPV16-positive CIN3. Participants received three immunizations of Vvax001 at a three-week interval and were monitored for regression of CIN3 for up to 19 weeks after the last immunization. Eighteen patients were enrolled and fully immunized. The researchers found a reduction in CIN3 lesion sizes in 17 of 18 patients (94 percent), which was evident from three weeks onward after the last immunization. Nine of the patients (50 percent) had a histopathological complete response (regression to CIN1 or no dysplasia ) and 63 percent of patients had HPV16 clearance. There was no clearance of other HPV types induced by Vvax001. No recurrences have been observed to date, with median and longest disease-free survival of 20 and 30 months, respectively. There were no serious adverse events reported. "Our findings demonstrate that the therapeutic vaccine Vvax001 is safe, well-tolerated, and effective in eradicating HPV16-associated CIN3 lesions and clearing the underlying persistent HPV16 infection in newly diagnosed untreated patients," the authors write. Several authors disclosed ties to the biopharmaceutical industry.