HPV Vaccination for Men Over 30 Years Old: Gardasil Dosing and Schedule
Gardasil is not routinely recommended for men over 30 years old, as standard ACIP guidelines recommend HPV vaccination for males only through age 26 years. 1
Standard Age Recommendations
Males aged 13-21 years: HPV4 (quadrivalent Gardasil) is recommended as routine catch-up vaccination if not previously vaccinated 1
Males aged 22-26 years: HPV4 may be administered (permissive recommendation, not routine) 1
Males over 26 years: No routine recommendation exists in ACIP guidelines from 2007-2014 1
FDA-Approved Dosing for Adults (If Vaccination Proceeds)
If a man over 30 receives Gardasil 9, the FDA-approved schedule is a 3-dose series administered at 0,2, and 6 months. 2
- Dose: 0.5 mL intramuscular injection 2
- Schedule for ages 15-45 years: 3 doses at 0,2, and 6 months 2
- Route: Intramuscular administration only 2
The FDA has licensed Gardasil 9 for use in males aged 9 through 45 years, which technically includes men over 30 2. However, this FDA approval does not equate to a public health recommendation.
Special Populations Where Vaccination May Be Considered
Men Who Have Sex With Men (MSM)
- HPV4 is specifically recommended for MSM through age 26 years who did not receive vaccination when younger, as they may especially benefit from protection against condyloma and anal cancer 1
- No guideline extension beyond age 26 exists even for MSM 1
Immunocompromised Individuals
- HPV vaccine is recommended for immunocompromised persons (including HIV infection) through age 26 years if not previously vaccinated 1
- For solid organ transplant candidates aged 11-26 years, the HPV vaccine series is recommended, ideally before transplantation 3
- The quadrivalent or nonavalent HPV vaccines are preferred for transplant recipients given the high prevalence of anogenital warts in immunosuppressed patients 3
Clinical Efficacy Evidence in Adult Males
In males aged 16-26 years, the quadrivalent HPV vaccine demonstrated efficacy in reducing external genital lesions (rate ratio 0.16,95% CI 0.07 to 0.38) and anogenital warts (rate ratio 0.11,95% CI 0.03 to 0.38) compared with control 4
A Phase II trial in men aged 27-45 years demonstrated 100% seroconversion to all four HPV vaccine components, with immune responses comparable to younger men in whom clinical efficacy was demonstrated 5
Important Caveats
Vaccination should ideally occur before potential HPV exposure through sexual activity, though sexually active individuals can still be vaccinated 1, 6
History of genital warts, abnormal testing, or positive HPV DNA does not preclude vaccination, as individuals may not have been infected with all vaccine HPV types 1, 6
HPV vaccination does not eliminate the need for cancer screening as recommended by healthcare providers 2
The vaccine does not treat existing HPV infections or disease; it only prevents future infections with vaccine-type HPV 2