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FRIDAY, April 5, 2019 (HealthDay News) — For women with cervical intraepithelial neoplasia (CIN) grade 2 or 3 associated with high-risk human papillomavirus (HPV), an immunotherapeutic tipapkinogen sovacivec (TS) HPV vaccine is effective for achieving histologic resolution, according to a study published online April 4 in Gynecologic Oncology<\/i>.<\/p>\n
Diane M. Harper, M.D., M.P.H., from the Helsinki University Hospital, and colleagues enrolled women aged 18 years and older who had confirmed CIN2\/3 in a placebo-controlled phase II trial and randomly assigned them to either vaccine or placebo in a 2:1 ratio (129 and 63 patients, respectively). The primary end point was histologic resolution of CIN2\/3 at excision performed at month 6. Cytology and high-risk HPV typing were performed through 30 months.<\/p>\n
The researchers found that complete resolution of CIN2\/3 was significantly higher in the vaccine group versus the placebo group (24 versus 10 percent; P < 0.05), regardless of the 13 high-risk HPV types assayed. The same findings were demonstrated for only CIN3 (21 versus 0 percent; P < 0.01), also regardless of high-risk HPV type. Viral DNA clearance was higher in the vaccine group versus the placebo group (P < 0.001), regardless of baseline HPV infection. The vaccine was well tolerated; injection site reactions were the most common adverse events.<\/p>\n
“Immunologic therapeutic HPV vaccines offer a potential nonsurgical option for women with cervical precancers which might be extended to other HPV-associated precursors or cancers in the future,” the authors write.<\/p>\n
Several authors disclosed financial ties to pharmaceutical companies, including Roche, which funded the study and sold the compound to Transgene who facilitated data analysis.<\/p>\n