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Online Clinical Calculator |
HPV vaccine prevents CIN
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Clinical Question:
Does human papillomavirus-16 vaccination prevent cervical intraepithelial
neoplasia?
Bottom Line:
The vaccine HPV16 L1 VLP provides high-level protection against persistent
HPV16 infection and HPV16-related CIN2-3 for at least 3.5 years after
immunization. Administration of L1 VLP vaccines targeting HPV16 is likely to
reduce risk for cervical cancer. LEVEL OF EVIDENCE: I.
Reference:
Mao C, Koutsky LA, Ault KA, et al. Efficacy of human papillomavirus-16
vaccine to prevent cervical intraepithelial neoplasia. Obstet Gynecol
2006;107:18-27. |
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Study Design:
Randomized controlled trial (double-blinded)
Synopsis:
Human papillomavirus (HPV) virus-like particle (VLP) vaccines have
demonstrated effectiveness in preventing persistent HPV infections. Whether
protection lasts longer than 18 months and, thus, impacts rates of cervical
intraepithelial neoplasia (CIN) 2-3 has not yet been established. We present
results from an HPV16 L1 VLP vaccine trial through 48 months. A total of
2,391 women, aged 16-23 years, participated in a randomized, double-blind,
placebo-controlled trial. Either 40 mug HPV16 L1 VLP vaccine or placebo was
given intramuscularly at day 1, month 2, and month 6. Genital samples for
HPV16 DNA and Pap tests were obtained at day 1, month 7, and then 6-monthly
through month 48. Colposcopy and cervical biopsies were performed if
clinically indicated and at study exit. Serum HPV16 antibody titer was
measured by radioimmunoassay. Among 750 placebo recipients in the per
protocol population, 12 women developed HPV16-related CIN2-3 (6 CIN2 and 6
CIN3). Among 755 vaccine recipients, there were no cases (vaccine efficacy
100%, 95% confidence interval [CI] 65-100%). There were 111 cases of
persistent HPV16 infection in placebo recipients and 7 cases in vaccine
recipients (vaccine efficacy 94%, 95% CI 88-98%). After immunization, HPV16
serum antibody geometric mean titers peaked at month 7 (1,519 milli-Merck
units [mMU]/mL), declined through month 18 (202 mMU/mL), and remained
relatively stable between month 30 and month 48 (128-150 mMU/mL). |
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