Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study summary:

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


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.


Study is Available At:


Original ID:

32090


NCT ID:

NCT00572832


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

23 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard K. Zimmerman, MD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:September 2007
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:August 2010
Last Changed Date:August 11, 2010
First Received Date:December 11, 2007
First Results Date:September 3, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule
Time Frame:1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
Safety Issues:False
Description: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 t

Study Interventions

Intervention Type:Biological
Name:Quadrivalent human papillomavirus vaccine on-time
Description:The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
Arm Name:6 mon. 3rd dose of quadrivalent human papillomavi
Other Name:Gardasil
Intervention Type:Biological
Name:Quadrivalent human papillomavirus vaccine delayed
Description:The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
Arm Name:12 mon. 3rd dose of quadrivalent human papillomavi
Other Name:Gardasil

Study Arms

Study Arm Type:Active Comparator
Arm Name:12 mon. 3rd dose of quadrivalent human papillomavirus vaccine
Description:Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.
Study Arm Type:Active Comparator
Arm Name:6 mon. 3rd dose of quadrivalent human papillomavirus vaccine
Description:Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:20629576

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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