Immunogenicity of Off-Schedule Dosing of HPV Vaccine

Completed

Conditions studied: Papilloma Viral Infection

In brief

The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time and sometimes girls receive the shots at non-recommended times. This study will evaluate if getting the shots at non-recommended times affects the level of protection provided by the vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may answer a questionnaire related to the vaccine schedule. Study procedures include: medical history, questionnaires and blood draws. Participants will be involved in the study for about 6 months from time of enrollment.

Key facts

Study ID: NCT01030562
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 1321
Starts: 2010-06-02
Expected to finish: 2014-03-05
Last updated by the study team: 2018-10-29

Who can join

Age: 9 and older, up to 17. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Girls will be eligible if they are: -9 to 17 years of age (defined as between 9 years 0 days and younger than 18 years of age) at time of receipt of third HPV dose; -Receiving the third human papillomavirus (HPV) vaccine as part of routine health care; -Able and willing to complete all study visits and evaluations; -Able and willing to participate in the study by providing written informed assent/consent (as applicable); -Parent or legal guardian provides permission (as applicable). Parent/legal guardian inclusion criteria: At sites administering the survey and health literacy assessment, parent or legal guardian providing permission for their daughter to participate in the study will be eligible to participate in the parental questionnaire if they are able to provide informed consent for themselves.

You may not qualify if…

Girls meeting any of the following exclusion criteria at baseline will be excluded from study participation. -Unable to comply with the study protocol. -Receipt of more than 3 doses of human papillomavirus (HPV) vaccine. -Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period. -History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements. -History of malignancy or confirmed or suspected immunodeficient condition, such as human immunodeficiency virus infection. -Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. -Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids or any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication; nasal and topical steroids are allowed. -Current or former participation in HPV vaccine related research. -Receipt of an investigational or alternate (Cervarix) HPV vaccine. -Receipt of a live virus vaccine (varicella virus vaccine, any measles, mumps, or rubella virus vaccine, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks before or after the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine. However, subjects may receive any vaccine on the same day as the third dose of HPV. Parent/legal guardian exclusion criteria: If the site is actively recruiting adolescents from a clinic population, the survey and health literacy assessments are not available for the parents/legal guardians from that clinic population. Therefore they will not be asked to participate in the study. -At sites administering the survey and health literacy assessment, parents/legal guardians meeting any of the following exclusion criteria at baseline will be excluded from filling out the study questionnaire examining factors associated with adherence: -History of any physical, mental or developmental disorder that study personnel believe may hinder a participant's ability to comply with study requirements.

Where it is running

Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine — Tucker, Georgia, United States
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
Children's Mercy Hospital and Clinics - Infectious Diseases — Kansas City, Missouri, United States
Cincinnati Children?s Hospital Medical Center - Adolescent Medicine — Cincinnati, Ohio, United States
Primary Physicians Research Inc. - Pittsburgh — Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine — Nashville, Tennessee, United States
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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