Can Gardasil (Human Papillomavirus vaccine) be administered to adult males?

From the Guidelines

Yes, Gardasil can be given to male adults, and the HPV vaccine Gardasil 9 is FDA-approved for males up to age 45. The vaccine is most commonly recommended for boys and young men ages 11-26. The vaccine is administered as a series of two or three shots, depending on the age when vaccination begins. For those who start before age 15, two doses are given 6-12 months apart. For those starting at age 15 or older, three doses are needed (initial dose, followed by shots at 2 months and 6 months after the first dose) 1. The vaccine protects against HPV types that can cause genital warts and certain cancers, including penile, anal, and oropharyngeal cancers in men. While the vaccine is most effective when given before potential exposure to HPV through sexual activity, adult men can still benefit as they may not have been exposed to all HPV types covered by the vaccine. Some key points to consider:

• The vaccine is recommended for individuals 11 through 12 years of age, and can be started as early as age 9 1.
• Men who have sex with men (MSM) may especially benefit from vaccination to prevent condyloma and anal cancer 1.
• The vaccine can be administered to persons who are immunocompromised as a result of infection (including HIV infection), disease, or medications 1.
• Side effects are generally mild and may include pain at the injection site, fever, headache, and nausea. It's worth noting that the evidence suggests that the vaccine is safe and effective in preventing HPV-related cancers and diseases, and that it can be given to male adults up to age 45 1.

From the FDA Drug Label

Effectiveness of GARDASIL 9 against persistent infection and disease related to vaccine HPV types in 16- through 26-year-old boys and men was inferred from non-inferiority comparison conducted in the PPI population in Study 7 of GMTs following vaccination with GARDASIL 9 among 16- through 26-year-old HM with those among 16- through 26-year-old girls and women. Study 7 also enrolled 313 16- through 26-year-old HIV-negative MSM. At Month 7, anti-HPV GMT ratios for MSM relative to HM ranged from 0.6 to 0. 8, depending on HPV type. The GMT ratios for MSM relative to HM were generally similar to those previously observed in clinical trials with GARDASIL The answer is yes, Gardasil can be given to male adults, as supported by Study 7, which demonstrated non-inferiority of immune responses in 16- through 26-year-old boys and men compared to 16- through 26-year-old girls and women 2.

• Key points:
  • Study 7 showed non-inferiority of immune responses in male adults
  • The study enrolled 16- through 26-year-old HIV-negative MSM
  • GMT ratios for MSM relative to HM were generally similar to those previously observed in clinical trials with GARDASIL

From the Research

Gardasil Vaccination for Male Adults

• The Gardasil vaccine, also known as the quadrivalent human papillomavirus vaccine (qHPV), has been licensed for use in males aged 9 through 26 years for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11 3.
• The vaccine has been shown to be effective in reducing the rates of anal intraepithelial neoplasia, including grade 2 or 3, among men who have sex with men 4.
• The Advisory Committee on Immunization Practices (ACIP) recommends that HPV4 may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts, but does not recommend it for routine use among males 3.
• The vaccine has a favorable safety profile and may help to reduce the risk of anal cancer 4.

Target Population for Vaccination

• Men who have sex with men are at a higher risk of acquiring genital warts and anal cancer, and may benefit from vaccination with Gardasil 4, 3.
• Individuals with Human Immunodeficiency Virus-1 (HIV-1) infection are also at a higher risk of acquiring genital warts and anal cancer, and may benefit from vaccination with Gardasil 5.
• The optimal age for vaccination is prior to identification with any high-risk groups, and universal vaccination against HPV represents the best strategy to achieve maximum protection against anal cancer in high-risk groups 5.

Efficacy and Safety of the Vaccine

• The qHPV vaccine has been shown to be effective in reducing the rates of anal intraepithelial neoplasia, including grade 2 or 3, among men who have sex with men 4.
• The vaccine has a favorable safety profile, with no vaccine-related serious adverse events reported 4.
• Systematic reviews and meta-analyses have shown that HPV vaccination effectively prevents HPV infection, precancerous lesions of the anogenital tract, and genital warts 6.