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Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia
New England Journal of Medicine, 11/10/09

Kenter GG et al. – Clinical responses 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-16–specific immunity.

Methods

Immunogenicity and efficacy of a synthetic long-peptide vaccine in women with HPV-16–positive, high-grade vulvar intraepithelial neoplasia investigated
20 women with HPV-16–positive, grade 3 vulvar intraepithelial neoplasia vaccinated 3 or 4 times with mix of long peptides from HPV-16 viral oncoproteins E6 and E7 in incomplete Freund's adjuvant
End points were clinical and HPV-16–specific T-cell responses

Results

Most common adverse events were local swelling in 100% of patients and fever in 64% of patients
No events exceeded grade 2 of the Common Terminology Criteria for Adverse Events of the National Cancer Institute
At 3 months after last vaccination, 12 of 20 patients (60%; 95% confidence interval [CI], 36 to 81) had clinical responses and reported relief of symptoms
5 women had complete regression of lesions, and HPV-16 was no longer detectable in 4 of them
At 12 months of follow-up, 15 of 19 patients had clinical responses (79%; 95% CI, 54 to 94), with complete response in 9 of 19 patients (47%; 95% CI, 24 to 71)
Complete-response rate maintained at 24 months of follow-up
All patients had vaccine-induced T-cell responses, and post hoc analyses suggested that patients with a complete response at 3 months had a significantly stronger interferon-&Upsilon–associated proliferative CD4+ T-cell response and a broad response of CD8+ interferon-&Upsilon- T cells than did patients without a complete response