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

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ClinicalTrials.gov Identifier: NCT01184079

Recruitment Status : Completed

First Posted : August 18, 2010

Results First Posted : February 26, 2014

Last Update Posted : March 27, 2014

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Richard Zimmerman, University of Pittsburgh

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Quadrivalent HPV Vaccine Human Papillomavirus Vaccine	Biological: quadrivalent human papillomavirus vaccine	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Study Start Date :	October 2010
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 12 months Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine	Biological: quadrivalent human papillomavirus vaccine 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months Other Name: Gardasil
Active Comparator: 6 month Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine	Biological: quadrivalent human papillomavirus vaccine 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months Other Name: Gardasil

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 26 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184079

Locations

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

University of Pittsburgh

Merck Sharp & Dohme Corp.

Investigators

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Principal Investigator:	Richard K Zimmerman, MD MPH	University of Pittsburgh

More Information

Publications of Results:

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Richard Zimmerman, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01184079
Other Study ID Numbers:	IISP#38206 PRO10070407 ( Other Identifier: University of Pittsburgh IRB ) I#0021806 ( Other Identifier: University of Pittsburgh InfoEd )
First Posted:	August 18, 2010 Key Record Dates
Results First Posted:	February 26, 2014
Last Update Posted:	March 27, 2014
Last Verified:	February 2014

Keywords provided by Richard Zimmerman, University of Pittsburgh:


human papillomavirus vaccine L1, type 6,11,16,18 HPV Vaccines HPV L1 vaccine, quadrivalent 6,11,16,18

Additional relevant MeSH terms:

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Vaccines Immunologic Factors Physiological Effects of Drugs

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