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

University of Pittsburgh

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Biological: Quadrivalent human papillomavirus vaccine delayed administration; Biological: Quadrivalent human papillomavirus vaccine on-time administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00572832

32090

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 23 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

6 mon. 3rd dose of quadrivalent human papillomavirus vaccine

Active Comparator group

Description:

Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.

Treatment:

Biological: Quadrivalent human papillomavirus vaccine on-time administration

12 mon. 3rd dose of quadrivalent human papillomavirus vaccine

Active Comparator group

Description:

Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.

Treatment:

Biological: Quadrivalent human papillomavirus vaccine delayed administration