Epidemiologic studies taught us that as a woman increases her sexual partners, she more likely will develop cervical cancer. More recently we have learned that infection with certain strains of HPV (the human papilloma virus) causes cervical cancer.

Now we have data showing that we can prevent cervical cancer using a new HPV vaccine – Vaccine Against HPV Strain Protects Against High-Grade Cervical Neoplasia

Therefore, the investigative team randomized 2,391 women aged 16 to 23 years to receive three doses of placebo or a vaccine consisting of HPV 16 virus-like particles (VLP). The vaccine, given in 40-µg doses, was administered at day 0 and then at month 2 and month 6. The investigators also obtained genital samples for HPV 16 DNA at day 0, month 7, and then every six months through month 48; the participants also underwent a Pap test at those visits.

The analysis population included women who completed the entire vaccine regimen, were negative for HPV 16 through month 7, and completed at least one additional visit. Patients underwent colposcopies and cervical biopsies as clinically indicated.

Of the 750 placebo recipients who met the criteria for evaluation, the investigators documented 12 cases of HPV 16–related CIN 2-3, six of which were CIN 2 and six of which were CIN 3. Of the 755 vaccinees, no such events were observed, for a vaccine efficiency of 100% (95% confidence interval [CI], 65% – 100%).

Through the end of the study, 111 subjects in the placebo group developed persistent HPV 16 infection compared with seven subjects in the vaccination group, for a vaccine efficacy of 94% (95% CI, 88% – 98%). After immunization, HPV 16 antibody titers peaked at month 7 (GMT 1519 mMu/mL) and declined through month 18 (GMT 202 mMu/mL). The titers remained relatively stable from month 30 through the study’s end (GMTs range, 128 – 150 mMu/mL).

“After three and a half years of follow-up, we concluded that the vaccine was able to prevent clinical cervical disease,” Dr. Mao said. “That’s the first time that’s been done in a human study. The next step will be to complete phase 3 trials of an ongoing study of a quadrivalent HPV vaccine, which also looks at men and children. If the vaccine is safe and effective, it would make sense to immunize children and young adolescents before they become sexually active.” Men are being studied for the quadrivalent vaccine because HPV is sexually transmitted, Dr. Mao said.

I have heard rumors that this vaccine (produced by Merck) either has received or will soon receive approval. This vaccine will probably become standard for adolescents. Of course that assumes that adolescents have sex. And that is probably an easy assumption to make.

Related posts:

1. Vaccinating against cervical cancer
2. Great summary on cervical cancer screening
3. New guidelines for cervical cancer screening
4. Cervical cancer screening in the UK – new recommendations
5. A vaccine for HPV

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