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


N/A
18 Years
23 Years
Not Enrolling
Female
Human Papillomavirus Infection

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule

Outcome Description:

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.

Outcome Time Frame:

1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)

Safety Issue:

No

Principal Investigator

Richard K. Zimmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

32090

NCT ID:

NCT00572832

Start Date:

September 2007

Completion Date:

August 2009

Related Keywords:

  • Human Papillomavirus Infection
  • Human Papillomavirus Vaccine
  • Papilloma
  • Warts
  • Papillomavirus Infections

Name

Location
University of Pittsburgh Pittsburgh, Pennsylvania  15261