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

NCT ID: NCT00572832

Last Updated: 2010-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-08-31

Brief 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.

Detailed 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

Conditions

Human Papillomavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

6 mon. 3rd dose of quadrivalent human papillomavirus vaccine

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

Group Type: ACTIVE_COMPARATOR

Quadrivalent human papillomavirus vaccine on-time administration

Intervention Type: BIOLOGICAL

The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.

12 mon. 3rd dose of quadrivalent human papillomavirus vaccine

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

Group Type: ACTIVE_COMPARATOR

Quadrivalent human papillomavirus vaccine delayed administration

Intervention Type: BIOLOGICAL

The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil; Gardasil

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh

Principal Investigators

Richard K. Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1089/jwh.2009.1753.

Reference Type: RESULT

PMID: 20629576 (View on PubMed)

Other Identifiers

32090

Identifier Type: -

Identifier Source: org_study_id