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Vaccine appears effective in HPV-16–positive, high-grade vulvular intraepithelial neoplasia
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A synthetic long-peptide vaccine against specific HPV-16 oncoproteins appeared to achieve clinical responses in women with HPV-16–positive, grade-3 vulvular intraepithelial neoplasia, according to recently published data.
To evaluate the immunogenicity and efficacy of the vaccine, researchers vaccinated 20 women with HPV-16–positive, high-grade vulvular intraepithelial neoplasia three to four times. The vaccine included a mix of long peptides from the HPV-16 viral oncoproteins E6 and E7 in incomplete Freund’s adjuvant. The peptides were 30 to 40 amino acids in length.
Three months after the last vaccination, 12 of the patients (60%) demonstrated clinical response and reported symptom relief. Five women experienced complete regression of the lesions, and researchers could no longer detect HPV-16 in four women. After one year of follow-up, the percentage of patients who demonstrated clinical response increased to 79%, with 47% having a complete response. This complete response rate remained at two years.
The researchers also reported that complete response appeared to correlate with induction of HPV-16–specific immunity. Post-hoc analyses demonstrated that those patients with complete response at three months also had a stronger interferon-γ–associated proliferative CD4+ T-cell response and CD8+ interferon-γ T cell response than patients without complete response.
All patients reported local swelling, and 64% reported fever, although these adverse events were grade 2 or less.
This study suggests that immune responses generated against precursor lesions may be more effective than those generated against late-stage disease, Olivera J. Finn, PhD, and Robert P. Edwards, MD, of the University of Pittsburgh School of Medicine, wrote in an accompanying editorial.
They added, “Until recently, the treatment of vulvular intraepithelial neoplasia was limited to ablation with a carbon dioxide laser for low-grade lesions or wide local excision for high-grade vulvular intraepithelial neoplasia. … Less invasive therapeutic approaches that provide durable protection from recurrence are needed. The study [by Kenter et al] provides support for immunotherapy as one such approach.”
Kenter GG. N Engl J Med. 2009;361(19):1838-1847.