Gardasil for Men: Guide on HPV Vaccination for Male Patients

Gardasil for men is one of the few vaccinations approved by the Food and Drug Administration (FDA) to treat human papillomavirus (HPV)-related diseases.

HPV is among the most prevalent sexually transmitted infections. Over 40 HPV types can infect both men and women and affect the genital, anal, and oropharyngeal regions. These include the penis, vulva, anus, cervix, rectum, and oral mucosa. 

This article explains everything you need to know about Gardasil for men, its clinical efficacy and safety, how it is administered, and the recommended vaccination schedules.

Key Takeaways

• Gardasil is a recombinant HPV vaccine available in quadrivalent (Gardasil-4) and nonavalent (Gardasil-9) formulations.
• Over 98% of recipients develop HPV antibodies within one month of completing vaccination.
• Gardasil-4 was discontinued in favor of Gardasil-9, which provides broader protection against nine high-risk HPV types, covering ~90% of cervical cancer cases.
• The vaccine is administered intramuscularly in the deltoid or anterolateral thigh, with a 2-dose (ages 9–14) or 3-dose (ages 15–45) schedule.
• The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination at ages 11–12, with catch-up vaccination for up to 26 years and individualized decisions for 27–45 years.
• Men who have sex with men (MSM) and HIV-positive males are at higher risk for persistent HPV infections and HPV-related cancers and should receive Gardasil.
• The most common side effects of Gardasil for men include pain, swelling, and redness at the injection site, along with headache, fever, and dizziness.
• Gardasil-9 is contraindicated in individuals with severe yeast allergies or hypersensitivity to vaccine components.
• The vaccine does not treat existing HPV infections but helps prevent new infections with other high-risk HPV types.

What Is Gardasil?

Gardasil is a recombinant quadrivalent (Gardasil-4) or nonavalent (Gardasil-9) human papillomavirus (HPV) vaccine that protects against HPV-related diseases, including genital warts, and cervical, anal, penile, vulvar, vaginal, and oropharyngeal cancers. It is manufactured using virus-like particles (VLPs) derived from the L1 capsid protein of HPV. ^[1]

Gardasil contains:

• VLPs of HPV L1 capsid protein — Induces an immune response without containing a live virus or viral DNA
• Amorphous aluminum hydroxyphosphate sulfate (AAHS) — Improves immunogenicity
• Excipients — Include sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection

Gardasil induces a humoral immune response by generating high titers of neutralizing antibodies against HPV L1 capsid proteins. Once administered, the VLPs are phagocytosed by antigen-presenting cells (APCs), leading to the activation of B cells and CD4+ T-helper cells.

The immune system generates high-affinity neutralizing antibodies, which prevent HPV virions from binding to basal epithelial cells, thereby blocking infection.

Evolution of Gardasil

There are two formulations of Gardasil for men:

1. Gardasil-4 (quadrivalent)
2. Gardasil-9 (nonavalent) 

Gardasil-4, approved in 2006, provided immunity against HPV types 6, 11, 16, and 18. It covered genital warts and approximately 70% of HPV-related cervical cancers. It was eventually discontinued in favor of the expanded coverage offered by Gardasil-9.

Gardasil-9, approved in 2014, includes the original four HPV types plus five additional high-risk types (31, 33, 45, 52, and 58), increasing cervical cancer protection to ~90%. It remains the current standard for HPV vaccination, recommended for both males and females aged 9–45 years. 

Efficacy and Immunogenicity of Gardasil in Males

Gardasil benefits for men include a strong immune response, with over 98% of recipients developing antibodies against the targeted HPV types within one month of completing the full vaccination series.

A study showed that within one month of completing the three-dose series of the nonavalent HPV vaccine, nearly 100% of recipients developed antibodies against all nine HPV types, and 77.5–100% remained seropositive after five years. 

Antibody levels for HPV 6, 11, 16, and 18 were comparable between the nonavalent and quadrivalent vaccines. The nonavalent vaccine was also found to be safe for individuals who had previously received an HPV vaccine but sought additional protection against the five new HPV types. ^[2]

However, there is no established serologic marker of immunity and a minimum protective antibody titer has not been determined. 

A WHO-commissioned systematic review also found no difference in the rates of selected serious adverse events of Gardasil shot for men between those who received the HPV vaccine and those who did not. ^[3]

Dosage and Administration for Gardasil-9

Gardasil-9 should be administered via intramuscular injection in either the deltoid muscle of the upper arm or the anterolateral thigh. 

The dosing schedule varies based on the patient’s age, with the Gardasil age range in males extending from 9 to 45 years.

For individuals aged 9 to 14 years, the vaccine may be given as either a 2-dose or 3-dose regimen. In the 2-dose schedule, the second dose is administered 6 to 12 months after the first dose. However, if the second dose is given less than 5 months after the first, a third dose should be administered at least 4 months after the second. The 3-dose schedule follows a 0, 2-month, and 6-month interval.

For individuals aged 15 to 45 years, only the 3-dose schedule is recommended, with doses administered at 0, 2 months, and 6 months to ensure optimal immune response and long-term protection against HPV.

Current Guidelines for Male HPV Vaccination

The Advisory Committee on Immunization Practices (ACIP) endorses Gardasil-9 as one of three vaccines available for HPV prevention. According to ACIP guidelines, HPV vaccination is recommended for the following groups: ^[4]

• Children aged 11 or 12 years as part of routine immunization
• Unvaccinated males aged 13 to 21 years to ensure protection against HPV-related diseases
• Other high-risk populations who have not previously received the vaccine
• Catch-up vaccination is advised for everyone up to age 26 if not previously vaccinated

HPV vaccine prevents new infections but does not treat existing infections or diseases. It is most effective when given before HPV exposure. ^[5]

Safety Considerations for Gardasil-9 Use in Males

Gardasil-9 is contraindicated in males with a history of severe hypersensitivity reactions to any of its components or to Gardasil-4. Individuals with severe yeast allergies (Saccharomyces cerevisiae) should also not receive the vaccine due to the presence of yeast-derived proteins. 

Post-vaccination vasovagal syncope has been reported in some studies, which can result in fall-related injuries. 

In some cases, fainting is accompanied by tonic-clonic movements or rigidity that resembles seizure-like activity. To mitigate this risk, patients should remain seated or lying down for at least 15 minutes post-injection under medical supervision.

In addition, localized injection-site reactions are the most frequently reported side effects of Gardasil use in males. They include:

• Pain
• Swelling
• Erythema
• Pruritus
• Ecchymosis
• Induration

Systemic side effects include:

• Headache
• Fever
• Nausea
• Dizziness

FAQs

Does HPV Vaccination Impact Male Fertility?

No, HPV vaccination does not affect male fertility. In fact, HPV infection has been linked to reduced sperm quality and reproductive issues, so vaccination might be good for fertility.

Can Men Get Gardasil Vaccine if They Already Have HPV?

Yes, a patient can receive Gardasil-9 even if they already have HPV, but the vaccine does not treat existing infections. It will still provide protection against other HPV types the patient has not yet been exposed to.

Can Gardasil Be Given to Men Who Have Sex With Men (MSM) and HIV-Positive Males?

Yes, men who have sex with men (MSM) and HIV-positive males should receive Gardasil-9, as they are at higher risk for persistent HPV infections, genital warts, and HPV-related cancers (especially anal and oropharyngeal cancers).

Who Should Not Get Gardasil?

Gardasil 9 should not be given to:

• Individuals with a severe allergic reaction (anaphylaxis) to any vaccine component, including yeast (Saccharomyces cerevisiae)
• Those who had a serious allergic reaction to a previous dose of Gardasil-4 or Gardasil-9
• Individuals with a moderate or severe acute illness should delay vaccination until recovery

When Was Gardasil Approved for Men?

The FDA approved Gardasil-4 in 2006 to prevent HPV-related diseases and cancers. However, it is no longer distributed in the US since the FDA approved Gardasil-9 in 2014. 

Final Words

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If you’re a licensed medical practitioner looking for wholesale purchase of Gardasil for men, contact DoctorMedica for guidance on securing the best rates.

References

1. Brotherton JML, Giuliano AR, Markowitz LE, Dunne EF, Ogilvie GS. Monitoring the impact of HPV vaccine in males—Considerations and challenges. Papillomavirus Research. 2016;2:106-111. doi:https://doi.org/10.1016/j.pvr.2016.05.001
2. Kim S, Bae S. The Necessity of Human Papillomavirus Vaccination in Men: A Narrative Review. Urogenital Tract Infection. 2024;19(3):51-59. doi:https://doi.org/10.14777/uti.2448030015
3. Soliman M, Oredein O, Dass CR. Update on Safety and Efficacy of HPV Vaccines: Focus on Gardasil. International Journal of Molecular and Cellular Medicine. 2021;10(2):101-113. doi:https://doi.org/10.22088/IJMCM.BUMS.10.2.101
4. Information About GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant). Gardasil9-Adults. https://www.gardasil9.com/patient-a/what-is-gardasil-9/about-gardasil9/
5. SIGNORELLI C, ODONE A, CIORBA V, et al. Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence. Epidemiology and Infection. 2017;145(10):1962-1982. doi:https://doi.org/10.1017/s0950268817000747
6. Safety. www.who.int. https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/human-papillomavirus-vaccines/safety
7. Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices – Healthy People 2030 | odphp.health.gov. Health.gov. Published 2015. Accessed February 14, 2025. https://odphp.health.gov/healthypeople/tools-action/browse-evidence-based-resources/use-9-valent-human-papillomavirus-hpv-vaccine-updated-hpv-vaccination-recommendations-advisory-committee-immunization-practices
8. Centers for Disease Control and Prevention. HPV vaccine recommendations. CDC. Published November 16, 2021. https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html