Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

Study Overview
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Brief Summary
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The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, 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 Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month 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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1. Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, 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 Dose 3 at 6 months or Dose 3 at 12 months. Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3. No cytology studies or DNA studies will be conducted. 1.1 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. Determine the preference and compliance of the men for the timing of the third dose. 1.2 Hypothesis for non- inferiority: 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.

Official Title
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Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

Conditions
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Quadrivalent HPV Vaccine, Human Papillomavirus Vaccine

Intervention / Treatment
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* Biological: quadrivalent human papillomavirus vaccine
* Biological: quadrivalent human papillomavirus vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males age 18-26 Exclusion Criteria: Hospitalization within the past year Previous HPV vaccination >/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination History of genital warts Immunosuppression Other vaccines within 8 days of proposed HPV vaccination Hypersensitivity to yeast or HPV vaccine components Known autoimmune disorders Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed) Serious Adverse Reaction to HPV vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Experimental: 12 months<br>Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine | Biological: quadrivalent human papillomavirus vaccine<br>* 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months<br>* Other names: Gardasil;|
| Active Comparator: 6 month<br>Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine | Biological: quadrivalent human papillomavirus vaccine<br>* 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity After Dose 3 | Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups. | 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance With 3rd Dose | Determine the compliance of the men for the timing of the third dose. | at 3rd dose (i.e., at month 6 or month 12, depending on arm) | 
| Safety Profile | Total proportion of side effects reported after any dose, compared by arm. | 1 week after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papillomavirus vaccine L1, type 6,11,16,18, HPV Vaccines, HPV L1 vaccine, quadrivalent 6,11,16,18