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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00572832
First received: December 11, 2007
Last updated: August 11, 2010
Last verified: August 2010
  Purpose

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 Intervention
Human Papillomavirus Infection
Biological: Quadrivalent human papillomavirus vaccine on-time administration
Biological: Quadrivalent human papillomavirus vaccine delayed administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 23 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572832

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

Publications:
Responsible Party: Richard K. Zimmerman, MD/Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00572832     History of Changes
Other Study ID Numbers: 32090
Study First Received: December 11, 2007
Results First Received: September 3, 2009
Last Updated: August 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Human Papillomavirus Vaccine

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on October 16, 2014