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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572832
• Other study ID #: 32090
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: August 11, 2010
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 23 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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