Should a healthy 42-year-old man with genital warts be vaccinated with the human papillomavirus (HPV) vaccine (Gardasil 9)?

HPV Vaccination for a 42-Year-Old Man with Genital Warts

A 42-year-old man with genital warts is outside the FDA-approved age range and routine CDC recommendations for HPV vaccination, but vaccination may still be offered through shared clinical decision-making, recognizing that the presence of genital warts does not contraindicate vaccination and he remains susceptible to oncogenic HPV types he has not yet acquired. 1

Age-Based Eligibility and FDA Approval

• The FDA approved Gardasil 9 for males aged 9–26 years, with an extension to ages 27–45 years granted in October 2018. 1, 2
• At age 42, this patient falls within the FDA-approved age range (27–45 years), but vaccination in this age group requires shared clinical decision-making rather than routine recommendation. 1, 3
• Adults older than 45 years are outside the approved age range for HPV vaccination according to CDC and FDA guidelines. 1
• The CDC (ACIP) issues a permissive (optional) recommendation for males aged 22–26 years, with vaccination based on shared clinical decision-making for those aged 27–45 years because effectiveness may be reduced by prior HPV exposure. 1

Impact of Existing Genital Warts on Vaccination Decision

• The presence of genital warts does NOT contraindicate HPV vaccination and should NOT delay vaccine administration. 1, 4
• Genital warts are caused by HPV types 6 and 11 in approximately 90% of cases. 1, 5
• HPV vaccination provides NO therapeutic benefit for existing genital warts and will NOT accelerate resolution or prevent recurrence of the current infection. 1, 6
• A meta-analysis found that HPV vaccination does not reduce the recurrence rate of genital warts after treatment (overall effect estimate 1.02,95% CI 0.75–1.38). 6

Potential Benefits Despite Prior HPV Exposure

The key rationale for considering vaccination is protection against HPV types not yet acquired:

• Individuals with genital warts caused by HPV 6/11 remain susceptible to oncogenic HPV types 16 and 18, which cause approximately 70% of HPV-related cancers. 1, 4
• Men are at risk for HPV-associated anal cancer (≈89% HPV-associated), penile cancer (≈63%), and oropharyngeal cancer (≈72%). 1
• The vaccine only protects against future infections with vaccine-type HPV strains that the individual has not yet acquired. 1
• Even sexually active individuals should be vaccinated according to age-based recommendations because they are unlikely to have been infected with all vaccine HPV types. 5, 4

Practical Vaccination Considerations

Dosing Schedule

• For adults aged ≥15 years, a 3-dose schedule is required: doses at 0,1–2, and 6 months. 1, 5, 2
• The minimum interval is 4 weeks between doses 1 and 2, and 12 weeks between doses 2 and 3. 5

Pre-Vaccination Testing

• HPV testing is NOT required before vaccination and is not clinically useful in men because no FDA-cleared test exists for male specimens. 1
• No laboratory or clinical testing (Pap smear, HPV DNA test, or antibody test) is required before initiating HPV vaccination. 5, 4
• A history of genital warts, abnormal test results, or positive HPV tests are NOT contraindications to vaccination. 5, 4

Vaccine Product

• Gardasil 9 (9-valent HPV vaccine) is the only HPV vaccine available in the United States as of January 2017. 5
• It protects against HPV types 6,11,16,18,31,33,45,52, and 58. 5, 2

Shared Clinical Decision-Making Framework

When considering vaccination for this 42-year-old man, weigh the following factors:

Factors Favoring Vaccination:

• New or anticipated sexual partners 5
• Limited number of lifetime sexual partners 5
• Men who have sex with men (MSM) 7, 5
• Immunocompromising conditions 5
• Desire for protection against oncogenic HPV types not yet acquired 1

Factors Against Vaccination:

• Long-term mutually monogamous relationship 5
• Extensive prior HPV exposure (likely in a 42-year-old sexually active adult) 5
• Substantially reduced vaccine effectiveness due to existing infections 5
• The vaccine will not treat his current genital warts 1

Common Pitfalls to Avoid

• Do NOT postpone vaccination while awaiting treatment or clearance of genital warts if the decision to vaccinate has been made. 1
• Do NOT tell the patient that the vaccine will treat existing warts; it is purely preventive. 1
• Do NOT order HPV testing in male patients, as it lacks clinical utility and FDA-cleared assays are approved only for cervical samples. 1
• Do NOT assume condoms provide complete protection against HPV; transmission can occur from uncovered genital skin even when condoms are used. 1

Clinical Bottom Line

For this 42-year-old man with genital warts, vaccination is permissible but not routinely recommended. The decision should be individualized based on his sexual history, relationship status, and understanding that the vaccine will not treat his current warts but may protect against oncogenic HPV types (particularly 16 and 18) that cause anal, penile, and oropharyngeal cancers if he has not yet been exposed to them. 1, 5 The limited expected benefit given likely prior HPV exposure at age 42 must be balanced against the patient's specific risk factors and preferences. 1, 5