Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

Study Overview
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Brief Summary
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This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either vaccine at 6 months or vaccine at 12 months. Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.

Detailed Description
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The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable. Aims: Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3). Determine the side effect profile of a delayed third dose, in comparison to the standard schedule

Official Title
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Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Biological: Quadrivalent human papillomavirus vaccine on-time administration
* Biological: Quadrivalent human papillomavirus vaccine delayed administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-23 year old college females who are planning to return to the university for the next fall semester. Exclusion Criteria: Pregnancy or planned pregnancy. Prior receipt of HPV vaccine. Greater than four lifetime sexual partners. Immunosuppression. Anti-coagulant therapy. Breastfeeding. History of abnormal pap smear. Allergy to vaccine components.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine<br>Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. | Biological: Quadrivalent human papillomavirus vaccine on-time administration<br>* The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.<br>* Other names: Gardasil;|
| Active Comparator: 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine<br>Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months. | Biological: Quadrivalent human papillomavirus vaccine delayed administration<br>* The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule | Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type. | 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus Vaccine