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| ID | Type | Description | Link |
|---|---|---|---|
| PRO10070407 | Other Identifier | University of Pittsburgh IRB | |
| I#0021806 | Other Identifier | University of Pittsburgh InfoEd |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 months | Experimental | Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine |
|
| 6 month | Active Comparator | Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadrivalent human papillomavirus vaccine | Biological | 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months |
|
| 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) |
| 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. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Richard K Zimmerman, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20629576 | Background | Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753. | |
| 24342252 | Result | Lin CJ, Zimmerman RK, Nowalk MP, Huang HH, Raviotta JM. Randomized controlled trial of two dosing schedules for human papillomavirus vaccination among college age males. Vaccine. 2014 Feb 3;32(6):693-9. doi: 10.1016/j.vaccine.2013.11.098. Epub 2013 Dec 14. |
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Exclusion criteria were: >4 lifetime sexual partners, health problems that would interfere with the immune response or ability to complete the study, a hospitalization during the past year, hypersensitivity to yeast or HPV vaccine components, inability to complete appointments, received HPV vaccine or immunosuppressive medications.
From October 2010 through May 2011, college age men, ages 18-25 years, were recruited using a variety of strategies including fliers, class announcements, recommendations by university health centers, emails to campus organizations, bus and campus newspaper advertisements, and targeted Facebook® advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | 12 Month Administration | Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months |
| FG001 | 6 Month Administration | 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 12 Month Administration | Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months |
| BG001 | 6 Month Administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat | Posted | Geometric Mean | 95% Confidence Interval | mM units/ml | 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 12 Month Administration | Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months |
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Drop-out rates higher in the Alternate group; however, sample size was met for all HPV types. The effect of the Alternate dosing schedule on long-term clinical outcomes is unknown. One syncopal episode related to phlebotomy prior to vaccination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chyongchiou Jeng Lin, PhD | University of Pittsburgh Department of Family Medicine | 412/383-2360 | cjlin@pitt.edu |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| quadrivalent human papillomavirus vaccine | Biological | 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months |
|
|
| 1 week after vaccination |
| 26176493 | Derived | Zimmerman RK, Lin CJ, Raviotta JM, Nowalk MP. Do vitamin D levels affect antibody titers produced in response to HPV vaccine? Hum Vaccin Immunother. 2015;11(10):2345-9. doi: 10.1080/21645515.2015.1062955. |
3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Compliance With 3rd Dose | Determine the compliance of the men for the timing of the third dose. | Posted | Number | participants | at 3rd dose (i.e., at month 6 or month 12, depending on arm) |
|
|
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| Secondary | Safety Profile | Total proportion of side effects reported after any dose, compared by arm. | Intention-to-treat | Posted | Number | percentage of doses with side effects | 1 week after vaccination |
|
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|
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| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | 6 Month Administration | 3rd dose administration at 6 months quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months | 0 | 109 | 0 | 109 |
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| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |