Immunogenicity of Off-Schedule Dosing of HPV Vaccine
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.
Papilloma Viral Infection
|Study Design:||Observational Model: Cohort|
|Official Title:||Immunogenicity of the HPV-6, 11, 16, 18 Vaccine Among Adolescent Girls Who Receive Vaccine Doses at Non-recommended Intervals and Factors Related to Non-adherence|
- Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes. [ Time Frame: One month after the third HPV vaccine dose. ] [ Designated as safety issue: No ]
- Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes). [ Time Frame: One month after the third HPV vaccine dose. ] [ Designated as safety issue: No ]
- GMT to vaccine HPV serotypes as measured by anti-HPV cLIA. [ Time Frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose. ] [ Designated as safety issue: No ]
- Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes). [ Time Frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3.
Experimental/Primary Arm 3
This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late.
Experimental/Primary Arm 2
This primary arm will consist of subjects receiving the second dose substantially late/third dose on time.
Experimental/Primary Arm 1
This primary arm will consist of subjects receiving the second dose on time/third dose substantially late.
Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms.
The immune response to the quadrivalent human papillomavirus (HPV) vaccine in the non-clinical trial settings is unknown. In addition, the immune response following administration of vaccine at substantially prolonged intervals is unknown. Early indications suggest that many girls will be receiving the vaccine at prolonged intervals and that this timing may affect immunogenicity. The lack of knowledge about the immunogenicity of prolonged intervals between vaccine doses precludes evidence based recommendations for patients who are substantially late for their second or third dose. Some clinicians currently restart the series while others give the doses at the incorrect interval (unpublished observation) without the ability to counsel their patients as to their expected level of immune response or protection. Examining the immune response prior to the third dose and at one and six months after the third dose will allow a better understanding of the immunogenicity of this vaccine and immune response to booster doses. Furthermore, determining factors related to non-adherence in the adolescent age group is important and timely. As an increasing number of vaccines are being recommended to the adolescent age group, elucidating factors involved with non-adherence to the recommended dosing schedule is now critical. This information can guide interventions that aim to increase adolescent adherence to the recommended schedules. Eligible girls 9 - 17 years old receiving the quadrivalent HPV vaccine from their primary care provider will be enrolled into this study on the day of, but prior to, receiving their third HPV vaccine dose or at approximately 28 days after the third HPV dose . Blood for immunogenicity testing will be obtained up to three times throughout the study: one month (Study Day 28) and six months (Study Day 180) after the third dose (Study Day 0) for all subjects and just prior to the third dose for subjects on time for their third dose (regardless of the time interval between the first and second dose). The primary analysis will be based on comparing the geometric mean titer (GMTs) and seroresponse rate of subjects receiving the vaccine doses at substantially prolonged intervals to GMTs and seroresponse rate of subjects receiving the second and third dose on time. In addition, on Study Day 0, patient and parent related factors known to impact health care utilization may be measured using a questionnaire given to parents/legal guardians and 14 to 17 year old subjects. Analysis based on a health care utilization model will be used to determine factors associated with non-adherence to the vaccine schedule. Initially, all subjects meeting eligibility criteria will be enrolled regardless of timing of the second and third vaccine doses. When a study arm reaches the accrual target, it will be closed to enrollment. Enrollment for the entire study will remain open until the control and three primary experimental arms have completed enrollment One or more experimental arms may be dropped from the study after monitoring of accrual rates indicates that it/they cannot be fully enrolled in a timely fashion. Monitoring will occur monthly. Assessment of accrual rates will occur semi-annually. The primary objective is to compare the GMT one month after completing the three dose vaccination series in 9 to 17 year old subjects who received the second and/or third dose at substantially prolonged intervals to subjects who receive both the second and third dose on time after adjusting for age.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030562
|Contact: Lea E Widdice||(513) firstname.lastname@example.org|
|United States, Georgia|
|Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine||Recruiting|
|Tucker, Georgia, United States, 30084-7047|
|United States, Maryland|
|University of Maryland School of Medicine - Center for Vaccine Development - Baltimore||Recruiting|
|Baltimore, Maryland, United States, 21201-1509|
|United States, Missouri|
|Children's Mercy Hospital and Clinics - Infectious Diseases||Recruiting|
|Kansas City, Missouri, United States, 64108-4619|
|United States, Ohio|
|Cincinnati Children?s Hospital Medical Center - Adolescent Medicine||Recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Primary Physicians Research Inc. - Pittsburgh||Terminated|
|Pittsburgh, Pennsylvania, United States, 15241-3100|
|United States, Tennessee|
|Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine||Recruiting|
|Nashville, Tennessee, United States, 37232-0001|
|United States, Washington|
|Group Health Research Institute - Seattle||Recruiting|
|Seattle, Washington, United States, 98101-1466|