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Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory
Committee on Immunization Practices (ACIP).
Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for
Disease Control and Prevention (CDC); Advisory Committee on Immunization
Practices (ACIP).
Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD
and TB Prevention (proposed), Atlanta, GA 30333, USA. lem2@cdc.gov
These recommendations represent the first statement by the Advisory Committee on
Immunization Practices (ACIP) on the use of a quadrivalent human papillomavirus
(HPV) vaccine licensed by the U.S. Food and Drug Administration on June 8, 2006.
This report summarizes the epidemiology of HPV and associated diseases,
describes the licensed HPV vaccine, and provides recommendations for its use for
vaccination among females aged 9-26 years in the United States. Genital HPV is
the most common sexually transmitted infection in the United States; an
estimated 6.2 million persons are newly infected every year. Although the
majority of infections cause no clinical symptoms and are self-limited,
persistent infection with oncogenic types can cause cervical cancer in women.
HPV infection also is the cause of genital warts and is associated with other
anogenital cancers. Cervical cancer rates have decreased in the United States
because of widespread use of Papanicolaou testing, which can detect precancerous
lesions of the cervix before they develop into cancer; nevertheless, during
2007, an estimated 11,100 new cases will be diagnosed and approximately 3,700
women will die from cervical cancer. In certain countries where cervical cancer
screening is not routine, cervical cancer is a common cancer in women. The
licensed HPV vaccine is composed of the HPV L1 protein, the major capsid protein
of HPV. Expression of the L1 protein in yeast using recombinant DNA technology
produces noninfectious virus-like particles (VLP) that resemble HPV virions. The
quadrivalent HPV vaccine is a mixture of four HPV type-specific VLPs prepared
from the L1 proteins of HPV 6, 11, 16, and 18 combined with an aluminum
adjuvant. Clinical trials indicate that 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 6,
11, 16, or 18 among females who have not already been infected with the
respective HPV type. No evidence exists of protection against disease caused by
HPV types with which females are infected at the time of vaccination. However,
females infected with one or more vaccine HPV types before vaccination would be
protected against disease caused by the other vaccine HPV types. The vaccine is
administered by intramuscular injection, and the recommended schedule is a
3-dose series with the second and third doses administered 2 and 6 months after
the first dose. The recommended age for vaccination of females is 11-12 years.
Vaccine can be administered as young as age 9 years. Catch-up vaccination is
recommended for females aged 13--26 years who have not been previously
vaccinated. Vaccination is not a substitute for routine cervical cancer
screening, and vaccinated females should have cervical cancer screening as
recommended.

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