Novel Vaccine Tested for Vulvar Neoplasia

Many women with HPV-16-positive, grade 3 vulvar neoplasia had complete clinical response

WEDNESDAY, Nov. 4 (HealthDay News) -- Researchers from the Netherlands have developed a vaccine for vulvar intraepithelial neoplasia linked to the human papillomavirus-16 (HPV-16) that within a year produced a complete clinical response in 47 percent of women receiving it, according to a study in the Nov. 5 issue of the New England Journal of Medicine.

Gemma G. Kenter, M.D., of the Leiden University Medical Center in the Netherlands, and colleagues injected 20 women who had HPV-16-positive, grade 3 vulvar intraepithelial neoplasia with a vaccine formulated from synthetic long-peptide oncoproteins E6 and E7 in incomplete Freund's adjuvant. The researchers monitored the women's clinical response and HPV-16-specific T-cell responses.

Three months after vaccination, the researchers found that 25 percent of women had complete lesion regression, and 60 percent reported symptom relief. By 12 months, 79 percent of patients exhibited a clinical response, with 47 percent having a complete response that was still evident at 24-months follow-up. All subjects were found to have T-cell responses induced by the vaccine with stronger responses observed in the subjects who had complete clinical responses. Adverse effects included local swelling (100 percent of women) and fever (64 percent).

"Clinical response in women with HPV-16-positive, grade 3 vulvar intraepithelial neoplasia can be achieved by vaccination with a synthetic long-peptide vaccine against the HPV-16 oncoproteins E6 and E7. Complete responses appear to be correlated with induction of HPV-16specific immunity," the authors write.

ISA Pharmaceuticals supported the study; several authors reported financial relationships with the company.

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