Bradley S. Bender, MD
Is quadrivalent human papillomavirus (HPV) vaccine effective and safe for preventing external genital lesions and anogenital HPV infection in boys and men 16 to 26 years of age?
Randomized placebo-controlled trial. ClinicalTrials.gov NCT00090285.
Unclear allocation concealment.*
Blinded (participants, clinicians, laboratory staff, and assessors of biopsy specimens).*
Median 2.9 years after first dose of vaccine or placebo.
71 sites in 18 countries.
4065 healthy boys and men who were 16 to 23 years of age and had had 1 to 5 female sexual partners in their lifetime (for heterosexual men) or were 16 to 26 years of age and had 1 to 5 male or female partners in their lifetime (for men who had sex with men). Exclusion criteria were clinically detectable anogenital warts or genital lesions suggestive of non-HPV sexually transmitted diseases or a history of such findings.
3 doses of quadrivalent HPV L1 vaccine (Gardasil or Silgard, Merck, which contained HPV types 6, 11, 16, and 18 virus-like particles conjugated to an amorphous aluminum hydroxyphosphate sulfate adjuvant), given as a 0.5-mL injection into the deltoid muscle at 1 day, 2 months, and 6 months (n = 2032), or matching placebo (n = 2033).
Primary outcome was external genital lesions associated with HPV types 6, 11, 16, or 18 (external genital warts; or penile, perianal, or perineal cancer or intraepithelial neoplasia). Other outcomes included persistent infections with the 4 HPV types, detection of DNA associated with the 4 HPV types, and external genital lesions associated with any HPV type.
89% completed visits through 7 months (intention-to-treat analysis).
The HPV vaccine group had lower rates of external genital lesions, persistent infection, and detection of DNA related to HPV types 6, 11, 16, or 18 compared with placebo (Table). The vaccine group also had a lower rate of external genital lesions for any HPV type (Table) and a higher rate of injection site–related adverse events (60% vs 54%, P < 0.001), particularly injection site pain (57% vs 51%, P < 0.001).
Quadrivalent human papillomavirus (HPV) vaccine prevented external genital lesions and persistent infection related to HPV types 6, 11, 16, or 18 in boys and men 16 to 26 years of age.
Quadrivalent human papillomavirus (HPV) vaccine vs placebo in boys and men 16 to 26 years of age
†Vaccine efficacy = 100% × (1 − HPV vaccine event rate/placebo event rate).
Bender BS. Quadrivalent HPV vaccine prevented HPV infection and external genital lesions in boys and men 16 to 26 years of age. Ann Intern Med. ;154:JC5–10. doi: 10.7326/0003-4819-154-10-201105170-02010
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Published: Ann Intern Med. 2011;154(10):JC5-10.
Infectious Disease, Prevention/Screening, Vaccines/Immunization.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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