A therapeutic vaccine directed to the human papilloma type 16 (HPV16) induced regression in high -grade precacese cervical lesions, according to the results of a phase II clinical trial published in Clinical Cancer ResearchAn American Cancer Research Association Magazine.
“Almost all premalignant cervical lesions and cervical cancers are caused by HPV infection, with HPV16 involved in most cases,” said Refika Yigit, MD, principal researcher and oncological gynecologist at the University Center of the University of the University Groningen in the Netherlands.
In those with cervical intraepithelial neoplasia of grade 3 (CIN3), the cells are already on the road to malignancy. If it is not, approximately one third of these cases progress to cervical cancer within 10 years and approximately half in 30 years, Yigit explained.
“The main objective of our essay was to investigate whether our therapeutic vaccine, VVAX001, could offer a possible alternative treatment to the standard attention split, which is often associated with complications,” Yigit added.
The VVAX001 vaccine is a modified version of the Semliki forest virus that cannot be replicated and produces oncogenic proteins E6 and E7 that are expressed exclusively by infected cells with HPV16.
In phase II trial, 18 positive CIN3 patients for HPV16 received three doses of VVAX001 three weeks apart, and then routinely monitored by colposcopy before a final biopsy guided by colposcopy at 19 weeks after immunization.
Nine of the 18 patients experienced regression: six to low -grade dysplasia and three with complete regressions and without signs of dysplasia. The size of the injury was significantly reduced in all but one of the patients, and these reductions were evident within a month of finishing vaccination. The nine patients whose disease did not retreat received a loop splitting surgery, although no residual disease was found in four of these patients, which suggests that the additional time for surgery could have allowed the eradication of the complete injury, according to the authors .
“As far as we know, this response rate makes VVAX001 one of the most effective therapeutic vaccines for CIN3 lesions associated with HPV16 reported to date,” said Yigit. “If confirmed in a larger essay, our results could mean that at least half of patients with CIN3 could omit surgery and avoid all their possible side effects and complications.”
In the standard attention environment, HPV authorization is linked to a lower risk of recurrence, and Yigit said his team expects the same here. Ten of the 16 evaluated patients approved the HPV16, including the nine whose disease retreated. Two patients whose disease did not retreated also eliminated HPV16; However, their injuries housed other HPV strains.
After a medium tracking of 20 months, none of the patients had recurrences.
Study limitations include limited monitoring time, small sample size and lack of a control group for spontaneous regression due to ethical concerns.
This study was supported by the Dutch Cancer Society (KWF) and Vicinivax.