What is the recommended dosing schedule for Gardasil (Human Papillomavirus vaccine)?

Gardasil (HPV Vaccine) Dosing Schedule

The recommended dosing schedule for Gardasil (Human Papillomavirus vaccine) is a 2-dose series for individuals 9-14 years of age with doses given at 0 and 6-12 months, and a 3-dose series (0,2, and 6 months) for individuals 15-45 years of age. 1

Age-Based Dosing Recommendations

For Individuals 9-14 Years Old

• Primary recommendation: 2-dose schedule with the second dose administered 6-12 months after the first dose 1
• If the second dose is administered earlier than 5 months after the first dose, a third dose should be given at least 4 months after the second dose 1
• Vaccination can be started as young as age 9 years 2, 1
• The Centers for Disease Control and Prevention recommends administering the first dose of HPV vaccine to an 11-12 year old, making this the ideal age to start vaccination 2

For Individuals 15-45 Years Old

• 3-dose schedule is required with doses administered at 0,2, and 6 months 1
• Catch-up vaccination is recommended for females aged 13-26 years who have not been previously vaccinated 3
• The vaccine is approved for use in both males and females up to age 45 1

Administration Guidelines

• Administer intramuscularly in the deltoid or anterolateral area of the thigh 1
• Each dose is 0.5 mL 1
• Observe patients for 15 minutes after administration due to risk of syncope (fainting) 1
• The vaccine should be stored at 2°C-8°C (36°F-46°F) and should not be frozen 3

Special Considerations

• Ideally, vaccine should be administered before potential exposure to HPV through sexual activity; however, individuals who are sexually active should still be vaccinated 3
• History of genital warts, abnormal Papanicolaou test, or positive HPV DNA test is not evidence of prior infection with all vaccine HPV types; HPV vaccination is still recommended for these individuals 3
• Vaccination is not a substitute for routine cervical cancer screening, and vaccinated females should have cervical cancer screening as recommended 3
• For immunocompromised individuals, including those with HIV infection, a 3-dose schedule is recommended regardless of age 4

Common Pitfalls and Caveats

• Completing the full series is essential for optimal protection - ensure patients understand the importance of returning for subsequent doses 1
• If the vaccination schedule is interrupted, it is not necessary to restart the series; simply continue where the schedule was interrupted 3
• The vaccine provides no therapeutic benefit for existing HPV infections or established disease 1
• Syncope (fainting) can occur after vaccination, particularly in adolescents, so observation for 15 minutes post-vaccination is recommended 1
• Vaccination does not eliminate the need for regular cervical cancer screening according to established guidelines 1

Efficacy and Protection

• The vaccine has high efficacy in preventing persistent HPV infection, cervical cancer precursor lesions, vaginal and vulvar cancer precursor lesions, and genital warts caused by HPV types covered by the vaccine 3
• No evidence exists of protection against disease caused by HPV types with which individuals are infected at the time of vaccination 3
• However, individuals infected with one or more vaccine HPV types before vaccination would be protected against disease caused by the other vaccine HPV types 3

By following these dosing recommendations, healthcare providers can optimize protection against HPV-related diseases including cervical cancer and genital warts.