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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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:

  1. Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
  2. Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
  3. 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.

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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


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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Safety Profile [ Time Frame: 1 week after vaccination ]
    Total proportion of side effects reported after any dose, compared by arm.



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

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