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Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

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ClinicalTrials.gov Identifier: NCT00572832
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : February 25, 2010
Last Update Posted : August 17, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Pittsburgh

Study Description
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Brief Summary:

This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 vaccine at 6 months or vaccine at 12 months.

Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that 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.


Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Biological: Quadrivalent human papillomavirus vaccine on-time administration Biological: Quadrivalent human papillomavirus vaccine delayed administration Not Applicable

Detailed Description:

The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable.

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
Study Start Date : September 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine
Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
 Biological: Quadrivalent human papillomavirus vaccine on-time administration
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
Other Name: Gardasil
Active Comparator: 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine
Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.
 Biological: Quadrivalent human papillomavirus vaccine delayed administration
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
Other Name: Gardasil


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule [ Time Frame: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule) ]
    Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 23 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-23 year old college females who are planning to return to the university for the next fall semester.

Exclusion Criteria:

  • Pregnancy or planned pregnancy.
  • Prior receipt of HPV vaccine.
  • Greater than four lifetime sexual partners.
  • Immunosuppression.
  • Anti-coagulant therapy.
  • Breastfeeding.
  • History of abnormal pap smear.
  • Allergy to vaccine components.
Contacts and Locations
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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): NCT00572832


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Richard K. Zimmerman, MD University of Pittsburgh
More Information
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Publications of Results:

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Responsible Party: Richard K. Zimmerman, MD/Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00572832    
Other Study ID Numbers: 32090
First Posted: December 13, 2007    Key Record Dates
Results First Posted: February 25, 2010
Last Update Posted: August 17, 2010
Last Verified: August 2010
Keywords provided by University of Pittsburgh:
Human Papillomavirus Vaccine
Additional relevant MeSH terms:
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Papillomavirus Infections
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
 Virus Diseases
Infections
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs