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Brief Summary

GUIDELINE TITLE

Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP).

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Recommendations for Use of Human Papillomavirus (HPV) Vaccine

Recommendations for Routine Use and Catch-Up

Routine Vaccination of Females Aged 11 to 12 Years

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of females aged 11--12 years with 3 doses of quadrivalent HPV vaccine. The vaccination series can be started as young as age 9 years.

Catch-Up Vaccination of Females Aged 13 to 26 Years

Vaccination also is recommended for females aged 13 to 26 years who have not been previously vaccinated or who have not completed the full series. Ideally, vaccine should be administered before potential exposure to HPV through sexual contact; however, females who might have already been exposed to HPV should be vaccinated. Sexually active females who have not been infected with any of the HPV vaccine types would receive full benefit from vaccination. Vaccination would provide less benefit to females if they have already been infected with one or more of the four vaccine HPV types. However, it is not possible for a clinician to assess the extent to which sexually active persons would benefit from vaccination, and the risk for HPV infection might continue as long as persons are sexually active. Pap testing and screening for HPV DNA or HPV antibody are not needed before vaccination at any age.

Dosage and Administration

The vaccine should be shaken well before administration. The dose of quadrivalent HPV vaccine is 0.5 mL, administered intramuscularly (IM), preferably in the deltoid muscle.

Recommended Schedule

Quadrivalent HPV vaccine is administered in a 3-dose schedule. The second and third doses should be administered 2 and 6 months after the first dose.

Minimum Dosing Intervals and Management of Persons Who Were Incorrectly Vaccinated

The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum recommended interval between the second and third doses of vaccine is 12 weeks. Inadequate doses of quadrivalent HPV vaccine or vaccine doses received after a shorter-than-recommended dosing interval should be readministered.

Interrupted Vaccine Schedules

If the quadrivalent HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted. If the series is interrupted after the first dose, the second dose should be administered as soon as possible, and the second and third doses should be separated by an interval of at least 12 weeks. If only the third dose is delayed, it should be administered as soon as possible.

Simultaneous Administration with Other Vaccines

Although no data exist on administration of quadrivalent HPV vaccine with vaccines other than hepatitis B vaccine, quadrivalent HPV vaccine is not a live vaccine and has no components that adversely impact safety or efficacy of other vaccinations. Quadrivalent HPV vaccine can be administered at the same visit as other age appropriate vaccines, such as the tetanus, diphtheria, and pertussis (Tdap) and quadrivalent meningococcal conjugate (MCV4) vaccines. Administering all indicated vaccines together at a single visit increases the likelihood that adolescents and young adults will receive each of the vaccines on schedule. Each vaccine should be administered using a separate syringe at a different anatomic site.

Cervical Cancer Screening Among Vaccinated Females

Cervical cancer screening recommendations have not changed for females who receive HPV vaccine (refer to Table 2 in the original guideline document). HPV types in the vaccine are responsible for approximately 70% of cervical cancers; females who are vaccinated could subsequently be infected with a carcinogenic HPV type for which the quadrivalent vaccine does not provide protection. Furthermore, those who were sexually active before vaccination could have been infected with a vaccine type HPV before vaccination. Health-care providers administering quadrivalent HPV vaccine should educate women about the importance of cervical cancer screening.

Groups for Which Vaccine is Not Licensed

Vaccination of Females Aged <9 Years and >26 Years

Quadrivalent HPV vaccine is not licensed for use among females aged <9 years or those aged >26 years. Studies are ongoing among females aged >26 years. No studies are under way among children aged <9 years.

Vaccination of Males

Quadrivalent HPV vaccine is not licensed for use among males. Although data on immunogenicity and safety are available for males aged 9 to 15 years, no data exist on efficacy in males at any age. Efficacy studies in males are under way.

Special Situations Among Females Aged 9 to 26 Years

Equivocal or Abnormal Pap Test or Known HPV Infection

Females who have an equivocal or abnormal Pap test could be infected with any of approximately 40 high-risk or low-risk genital HPV types. Such females are unlikely to be infected with all four HPV vaccine types, and they might not be infected with any HPV vaccine type. Vaccination would provide protection against infection with HPV vaccine types not already acquired. With increasing severity of Pap test findings, the likelihood of infection with HPV 16 or 18 increases and the benefit of vaccination would decrease. Women should be advised that results from clinical trials do not indicate the vaccine will have any therapeutic effect on existing HPV infection or cervical lesions.

Females who have a positive HC2 High-Risk test conducted in conjunction with a Pap test could have infection with any of 13 high-risk types. This assay does not identify specific HPV types, and testing for specific HPV types is not conducted routinely in clinical practice. Women with a positive HC2 High-Risk test might not have been infected with any of the four HPV vaccine types. Vaccination would provide protection against infection with HPV vaccine types not already acquired. However, women should be advised that results from clinical trials do not indicate the vaccine will have any therapeutic effect on existing HPV infection or cervical lesions.

Genital Warts

A history of genital warts or clinically evident genital warts indicates infection with HPV, most often type 6 or 11. However, these females might not have infection with both HPV 6 and 11 or infection with HPV 16 or 18. Vaccination would provide protection against infection with HPV vaccine types not already acquired. However, females should be advised that results from clinical trials do not indicate the vaccine will have any therapeutic effect on existing HPV infection or genital warts.

Lactating Women

Lactating women can receive HPV vaccine.

Immunocompromised Persons

Because quadrivalent HPV vaccine is a noninfectious vaccine, it can be administered to females who are immunosuppressed as a result of disease or medications. However, the immune response and vaccine efficacy might be less than that in persons who are immunocompetent.

Vaccination During Pregnancy

Quadrivalent HPV vaccine is not recommended for use in pregnancy. The vaccine has not been causally associated with adverse outcomes of pregnancy or adverse events in the developing fetus. However, data on vaccination during pregnancy are limited. Until additional information is available, initiation of the vaccine series should be delayed until after completion of the pregnancy. If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose regimen should be delayed until after completion of the pregnancy. If a vaccine dose has been administered during pregnancy, no intervention is needed. A vaccine in pregnancy registry has been established; patients and health-care providers should report any exposure to quadrivalent HPV vaccine during pregnancy (telephone: 800-986-8999).

Precautions and Contraindications

Acute Illnesses

Quadrivalent HPV vaccine can be administered to persons with minor acute illnesses (e.g., diarrhea or mild upper respiratory tract infections with or without fever). Vaccination of persons with moderate or severe acute illnesses should be deferred until after the patient improves (Kroger et al., 2006).

Hypersensitivity or Allergy to Vaccine Components

Quadrivalent HPV vaccine is contraindicated for persons with a history of immediate hypersensitivity to yeast or to any vaccine component. Data from passive surveillance in Vaccine Adverse Event Reporting System (VAERS) indicates that recombinant yeast derived vaccines pose a minimal risk for anaphylactic reactions in persons with a history of allergic reactions to Saccharomyces cerevisiae (baker's yeast).

Preventing Syncope After Vaccination

Syncope (i.e., vasovagal or vasodepressor reaction) can occur after vaccination, most commonly among adolescents and young adults. Among reports to VAERS for any vaccine that were coded as syncope during 1990 to 2004, a total of 35% of these episodes were reported among persons aged 10 to 18 years. Through January 2007, the second most common report to VAERS following receipt of HPV vaccine was syncope. Vaccine providers should consider observing patients for 15 minutes after they receive HPV vaccine.

Reporting of Adverse Events After Vaccination

As with any newly licensed vaccine, surveillance for rare adverse events associated with administration of quadrivalent HPV vaccine is important for assessing its safety in widespread use. All clinically significant adverse events should be reported to VAERS at http://vaers.hhs.gov/, even if causal relation to vaccination is not certain. VAERS reporting forms and information are available electronically at http://www.vaers.hhs.gov/ or by telephone (800-822-7967). Web-based reporting is available and providers are encouraged to report electronically at https://secure.vaers.org/VaersDataEntryintro.htm to promote better timeliness and quality of safety data.

Safety surveillance for adolescent quadrivalent HPV vaccine, Tdap, MCV4, and other vaccines is being conducted on an ongoing basis in cooperation with the Food and Drug Administration (FDA). A vaccine in pregnancy registry has been established by Merck and Co., Inc.; patients and health-care providers should report any exposure to quadrivalent HPV vaccine during pregnancy (telephone: 800-986-8999).

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2007 Mar 23

GUIDELINE DEVELOPER(S)

Centers for Disease Control and Prevention - Federal Government Agency [U.S.]

SOURCE(S) OF FUNDING

United States Government

GUIDELINE COMMITTEE

Advisory Committee on Immunization Practices

Human Papillomavirus Vaccine Working Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Advisory Committee on Immunization Practices

Chairman: Jon Abramson, MD, Wake Forest University School of Medicine, Winston-Salem, North Carolina

Executive Secretary: Larry Pickering, MD, CDC, Atlanta, Georgia

Members: Ban Mishu Allos, MD, Vanderbilt University School of Medicine, Nashville, Tennessee; Judith Campbell, MD, Baylor College of Medicine, Houston, Texas; Robert Beck, JD, Consumer Representative, Palmyra, Virginia; Reginald Finger, MD, Focus on the Family, Colorado Springs, Colorado; Janet Gilsdorf, MD, University of Michigan, Ann Arbor, Michigan; Harry Hull, MD, Minnesota Department of Health, St. Paul, Minnesota; Tracy Lieu, MD, Harvard Pilgrim Health Care and Harvard Medical School, Boston, Massachusetts; Edgar Marcuse, MD, Children's Hospital and Regional Medical Center, Seattle, Washington; Dale Morse, MD, New York State Department of Health, Albany, New York; Julia Morita, MD, Chicago Department of Public Health, Chicago, Illinois; Gregory Poland, MD, Mayo Medical School, Rochester, Minnesota; Patricia Stinchfield, MSN, Children's Hospitals and Clinics of Minnesota, St. Paul, Minnesota; John J. Treanor, MD, University of Rochester, Rochester, New York; Robin Womeodu, MD, University Hospital, Memphis, Tennessee

Ex-Officio Members: James E. Cheek, MD, Indian Health Services, Albuquerque, New Mexico; Wayne Hachey, DO, Department of Defense, Falls Church, Virginia; Geoffrey S. Evans, MD, Health Resources and Services Administration, Rockville, Maryland; Bruce Gellin, MD, National Vaccine Program Office, Washington, DC; Linda Murphy, Centers for Medicare and Medicaid Services, Baltimore, Maryland; George T. Curlin, MD, National Institutes of Health, Bethesda, Maryland; Kristin Lee Nichol, MD, Department of Veterans Affairs, Minneapolis, Minnesota

Liaison Representatives: American Academy of Family Physicians, Jonathan Temte, MD, Madison, Wisconsin, and Doug Campos-Outcalt, MD, Phoenix, Arizona; American Academy of Pediatrics, Keith Powell, MD, Akron, Ohio, and Carol Baker, MD, Houston, Texas; America's Health Insurance Plans, Andrea Gelzer, MD, Hartford, Connecticut; American College Health Association, James C. Turner, MD, Charlottesville, Virginia; American College of Obstetricians and Gynecologists, Stanley Gall, MD, Louisville, Kentucky; American College of Physicians, Kathleen M. Neuzil, MD, Seattle, Washington; American Medical Association, Litjen Tan, PhD, Chicago, Illinois; American Pharmacists Association, Stephan L. Foster, PharmD, Memphis, Tennessee; Association of Teachers of Preventive Medicine, W. Paul McKinney, MD, Louisville, Kentucky; Biotechnology Industry Organization, Clement Lewin, PhD, Cambridge, Massachusetts; Canadian National Advisory Committee on Immunization, Monica Naus, MD, Vancouver, British Columbia; Healthcare Infection Control Practices Advisory Committee, Steve Gordon, MD, Cleveland, Ohio; Infectious Diseases Society of America, Samuel L. Katz, MD, Durham, North Carolina; London Department of Health, David Salisbury, MD, London, United Kingdom; National Association of County and City Health Officials, Nancy Bennett, MD, Rochester, New York, and Jeffrey S. Duchin, MD, Seattle, Washington; National Coalition for Adult Immunization, David A. Neumann, PhD, Alexandria, Virginia; National Foundation for Infectious Diseases, William Schaffner, MD, Nashville, Tennessee; National Immunization Council and Child Health Program, Romeo S. Rodriquez, Mexico City, Mexico; National Medical Association, Patricia Whitley-Williams, MD, New Brunswick, New Jersey; National Vaccine Advisory Committee, Gary Freed, MD, Swiftwater, Pennsylvania, and Peter Paradiso, PhD, Collegeville, Pennsylvania; Society for Adolescent Medicine, Amy B. Middleman, MD, Houston, Texas; Pharmaceutical Research and Manufacturers of America, Damian A. Araga, Swiftwater, Pennsylvania

Human Papillomavirus Vaccine Working Group

Chair: Janet Gilsdorf, MD, Ann Arbor, Michigan

Members: Robert L. Beck, JD, Palmyra, Virginia; Stuart Berman, MD, Atlanta, Georgia; Joseph Bocchini, MD, Shreveport, Louisiana; Harrell Chesson, PhD, Atlanta, Georgia; Carolyn Deal, PhD, Bethesda, Maryland; Shelley Deeks, MD, Toronto, Canada; John Douglas, MD, Atlanta, Georgia; Eileen F. Dunne, MD, Atlanta, Georgia; Dan Fishbein, MD, Atlanta, Georgia; Stanley Gall, MD, Louisville, Kentucky; Bruce Gellin, MD, Washington, DC; Karen Goldenthal, MD, Rockville, Maryland; Harry Hull, MD, St. Paul, Minnesota; Samuel Katz, MD, Durham, North Carolina; Katrin Kohn, MD; Herschel W. Lawson, MD, Atlanta, Georgia; Nicole Liddon, PhD, Atlanta, Georgia; Lauri E. Markowitz, MD, Atlanta, Georgia; Eric Mast, MD, Atlanta, Georgia; Alison Mawle, PhD, Atlanta, Georgia; Amy Middleman, MD, Houston, Texas; Siobhan O'Connor, MD, Atlanta, Georgia; Mona Saraiya, MD, Atlanta, Georgia; Debbie Saslow, PhD, Atlanta, Georgia; Jane Seward, MBBS, Atlanta, Georgia; Jonathan L. Temte, MD, Madison, Wisconsin; James Turner, MD, Charlottesville, Virginia; Elizabeth R. Unger, MD, Atlanta, Georgia; Gregory S. Wallace, MD, Atlanta, Georgia; Robin Womeodu, MD, Memphis, Tennessee; Richard Zimmerman, MD, Pittsburgh, Pennsylvania; and Jane Zucker, MD, New York, New York

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Centers for Disease Control and Prevention (CDC), our planners, and our content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. On behalf of CDC, Dr. Elizabeth Unger is involved in a material transfer agreement with Merck Research Laboratories to implement the competitive Luminex assay for HPV 6, 11, 16, and 18 serology. Presentations will not include any discussion of the unlabeled use of a product or a product under investigational use.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the Centers for Disease Control and Prevention (CDC) Web site:

Print copies: Available from the Centers for Disease Control and Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325;(202) 783-3238.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on April 19, 2007.

COPYRIGHT STATEMENT

No copyright restrictions apply.

DISCLAIMER

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