NCT01184079|CompletedResults
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Sponsor study identifier
Secondary identifiers
OTHER · University of Pittsburgh IRB
OTHER · University of Pittsburgh InfoEd
interventional
220
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2010
Actual (reported)August 18, 2010
Actual (reported)October 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 2012
Actual (reported)May 2012
Actual (reported)February 26, 2014
Actual (reported)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)
Compliance With 3rd Dose
at 3rd dose (i.e., at month 6 or month 12, depending on arm)
Safety Profile
1 week after vaccination
Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine
Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
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.
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.
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.
Richard K Zimmerman, MD MPH
University of Pittsburgh
220 participants (actual enrollment reported by the registry).
First Submitted
August 11, 2010
First Posted
August 18, 2010
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
The STOP-HPV Scale Up Study
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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.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
March 27, 2014
Results First Posted
February 26, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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