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Completed

NCT Number: NCT00572832

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

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.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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:

  • Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
  • Determine the side effect profile of a delayed third dose, in comparison to the standard schedule

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quadrivalent human papillomavirus vaccine on-time administration

Biological

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

Other names: Gardasil

Quadrivalent human papillomavirus vaccine delayed administration

Biological

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

Other names: Gardasil

Primary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 13, 2007
Registry last updated
Aug 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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