Alternate Dosing Schedules Study for HPV Vaccine (ADS)

November 19, 2014 updated by: Duke University

To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This is a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended.

Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised.

Please note: This record refers only to the randomized portion of the study where pain following vaccination was assessed. Please refer to NCT02280642 for the observational portion of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Chapel Hill Pediatrics
      • Durham, North Carolina, United States, 27704
        • Durham Pediatrics
      • Durham, North Carolina, United States, 27704
        • Duke Children's Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. A healthy, medically well female between the ages of 9 - 18 years. (Must be between 9 years and younger than 19 years of age) at time of enrollment

  2. Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only)

    • For Group 1 - EITHER 1) The second dose of HPV vaccine must not have been administered and it must be within the specified dosing interval for the second dose of HPV vaccine (> 90 days since the first dose of HPV vaccine) OR 2) The second dose of HPV vaccine must have been administered > 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose of HPV vaccine (> 60 days - < 180 days since the second dose of HPV)
    • For Group 2 - The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 180 days since the second dose of HPV)
    • For Group 3 - The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 60 days - < 180 days since the second dose of HPV)
    • For Group 4- The second dose of HPV vaccine must have been administered > 90 days after the first dose of HPV of HPV vaccine and it must be within the specified dosing interval for the third dose (> 180 days since the second dose of HPV)
  3. Ability and willingness to participate in the study by providing written informed assent. Verbal assent is acceptable for subjects less than 12 years of age.
  4. Parent/guardian provides informed consent
  5. Anticipated ability and willingness to complete all study visits and evaluations

Exclusion Criteria:

  1. Unable to comply with the study protocol
  2. Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows
  3. Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period
  4. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks of receipt of the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine
  5. History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements
  6. History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection
  7. Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids are any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication. Nasal and topical steroids are allowed.
  8. Current or former participation in HPV vaccine related research.
  9. Receipt of an investigational or alternate HPV vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Received HPV vaccine first
Biological: Received HPV vaccine first
Other: Received concomitant vaccines first
Biological: Received concomitant vaccines first

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Following HPV Vaccine
Time Frame: 10 minutes following vaccination

Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.
10 minutes following vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Emmanuel B Walter, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 15, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014388
  • CDC#U36/CCU319276 CFDA 93.283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe