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.
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
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
- 18-23 year old college females who are planning to return to the university for the
next fall semester.
- Pregnancy or planned pregnancy.
- Prior receipt of HPV vaccine.
- Greater than four lifetime sexual partners.
- Anti-coagulant therapy.
- History of abnormal pap smear.
- Allergy to vaccine components.