UPDATED RECOMMENDATIONS FOR THE USE OF A TWO DOSE SCHEDULE FOR HUMAN PAPILLOMA VIRUS VACCINATION
Stanley A Gall, MD
A
vaccine against human papilloma virus( HPV) was approved by the Food and Drug Administration( FDA) in 2006 and recommended by the Advisory Committee on Immunizations Practice( ACIP) for the prevention of cervical cancers and genital warts in 2006. Routine vaccinations at ages 11-12 were recommended initially for females in 2006 and for males since 2011( 1, 2). The recommended 3-dose schedule was for administration of vaccine at 0, 1 and 6 months. The updated recommendation is for use of a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9-14 years and is administered at 0 and 6-12 months’ schedule. The 3-dose vaccine schedule remains in effect for persons who initiate the vaccination series at age 15 through 26 years and for immunocompromised persons.
HPV infection causes cervical, vaginal and vulvar cancers in women, penile cancers in men, and oropharyngeal and anal cancers and genital warts in both men and women. It has been found in other cancers as well, with ongoing research. Three HPV vaccines are currently licensed in the US. HPV-4 and HPV-9( Gardasil 4, Gardasil 9) are licensed for females and males ages 9 through 26 years. HPV vaccine( HPV-2) Cervarix is licensed for use in females ages 9 through 26 years. As of late 2016, only Gardasil-9( 9v HPV) is being distributed in the U. S. 9 v HPV vaccine contains the oncogenic HPV types 16, 18, 31, 33, 45, 52, 58 and the non-oncogenic types 6 and 11.( 1)( 2)
A recent study was reported to determine whether a 2-dose schedule( 0,-6-12 months) was equivalent to the 3-dose schedule( 0,1,6-12 months) using two doses of 9 v HPV, 4 v HPV or 2 v HPV in persons 9 through 14 years and compared to clinical endpoints demonstrated in clinical trials using the 3-dose regimen.( 3) Immunogenicity outcomes studied were sero-conversion, geometric mean titers( GMT) or antibody avidity.
There were 1,377 participants in the study and the seroconversion to all nine HPV types was 97.9 percent by four weeks after the last dose of vaccine. For persons who received two doses( 0, 6-12 months) compared to those receiving the three doses( 0, 1, 6-12 months) the results were similar for sero-conversions and
GMT. Interestingly, GMTs were significantly greater for the 9-14 years and subjects receiving the 2-dose schedules compared to the persons 16-26 receiving the 3-dose regimen.
The ACIP recommends routine HPV vaccinations at ages 11-12, but this vaccine can be initiated at age 9, for females through age 26, and for males through age 21. The ACIP recommends HPV vaccination in males who have sex with men through age 26.( 4)
For persons who are vaccinated prior to their 15 th birthday, they should receive an additional two doses of vaccine( 0, 6-12 months). After the 15 th birthday, the three dose schedule should be followed( 0, 1, and 6-12 months).
For persons who initiated vaccinations before their 15 th birthday, they should receive two doses of any HPV vaccine at 0, 1, 6-12 month schedule. 9 v HPV may be used to continue or complete a vaccination series started with 4 v HPV or 2 v HPV.
If a vaccine schedule has been interrupted, the series does not need to be restarted. ACIP recommends the 3-dose series of HPV vaccine for males and females ages 9-26 with primary or secondary immuno compromised conditions.
Contraindications and precautions including those related to pregnancy are unchanged from previous recommendations( 1)( 2).
Dr. Gall practices obstetrics, gynecology and women’ s health as part of the University of Louisville Physicians Group.
BIBLIOGRAPHY
1. Markovitz LE, Dunne EE, Saraiya. M etal Human papilloma virus vaccination: recommendations of the Advisory Committee on Immunization Practices( ACIP) MMWR Recomm Rep 2014; 63:( RR-05)
2. Petrosky E, Bocchini; JA Jr, Hatiri S, etal: Use of 9-Valent human papillomaviruses( HPV) Vaccine: Updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mort Wkly Rep 2015; 64: 300-304.
3. Iverson O, Mirande MI, Llied A. etal: Immunogenicity of 9 Valent HPV Vaccine using 2 dose regimens in girls and boys vs a 3 dose regimen in women JAMA 2016; 316: 2411-2421
4. Use of a 2 dose Schedule for Human Papilloma Vaccinations – updated recommendations of the Advisory Committee on Immunization Practices MMWR 2016; 65: 1405-1408
MARCH 2017 21