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
Interventional
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration 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.
1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
No
Richard K. Zimmerman, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
32090
NCT00572832
September 2007
August 2009
Name | Location |
---|---|
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |