Bruno P. Granwehr, MD, MS
In women 24 to 45 years of age, does quadrivalent human papillomavirus (HPV) recombinant vaccine prevent HPV infection and related disease?
Randomized placebo-controlled trial. ClinicalTrials.gov NCT00090220.
Blinded (participants, investigators, site personnel, monitors, and central laboratory personnel).*
Mean 2.2 years.
38 community health centers, academic health centers, and primary health care practices in the USA, Colombia, France, Germany, Philippines, Spain, and Thailand.
3819 women (mean age 34 y). Exclusion criteria were pregnancy, previous hysterectomy or cervical surgery, history of genital warts, previous or current cervical disease, cervical biopsy in the past 5 years, and HIV infection or immunocompromised status.
Amorphous aluminum hydroxyphosphate sulfate adjuvanted quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine (n = 1911) or aluminum-containing placebo (n = 1908) administered on day 1 and at months 2 and 6.
Composite of infection ≥ 6 months’ duration and cervical and external genital disease related to HPV 6, 11, 16, or 18, and to HPV 16 or 18 only. Secondary outcomes included combined incidence of infection ≥ 6 months’ duration and cervical and external genital disease related to HPV 6 or 11.
96% (99% included in intention-to-treat analysis).
At baseline, 33% of women were positive for ≥ 1 HPV type, but 90% were susceptible to ≥ 3 of HPV 6, 11, 16, and 18. At a mean follow-up of 2.2 years, HPV vaccine reduced infections and disease related to HPV 6, 11, 16, or 18 and HPV 6 or 11 only but not those related to HPV 16 or 18 only (Table).
In women 24 to 45 years of age, quadrivalent human papillomavirus (HPV) recombinant vaccine reduced risk for HPV-related infections and disease.
Human papillomavirus (HPV) vaccine vs placebo to prevent HPV infection and related disease†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
Granwehr BP. Quadrivalent HPV vaccine reduced risk for HPV infection and related disease in women 24 to 45 years of age. Ann Intern Med. ;151:JC4–12. doi: 10.7326/0003-4819-151-8-200910200-02012
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Published: Ann Intern Med. 2009;151(8):JC4-12.
Infectious Disease, Prevention/Screening, Vaccines/Immunization.
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