Alternate Dosing Schedules Study for HPV Vaccine (ADS) (ADS)

October 29, 2014 updated by: Duke University

Alternate Dosing Schedules Study for HPV Vaccine

The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited 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 was 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 were 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.

In addition, girls receiving a 3rd dose of HPV vaccine as well as 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 observational portion of the study. Please refer to NCT00862810 for the results of the randomized portion of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

331

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

Sampling Method

Non-Probability Sample

Study Population

Adolescent females attending primary care clinics in central North Carolina

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Both doses on time
An on time dose 2 was defined as ≥ 30 days to ≤ 90 days after dose 1 and an on time dose 3 was defined as ≥ 60 days to ≤ 180 days after dose 2.
Biological: Both 2nd and 3rd doses on time
Dose 2 delayed
A delayed dose 2 was defined as > 90 days after dose 1 and an on time dose 3 was defined as ≥ 60 days to ≤ 180 days after dose 2.
Biological: 2nd dose late and 3rd dose on time
Dose 3 delayed
An on time dose 2 was defined as ≥ 30 days to ≤ 90 days after dose 1 and a delayed dose 3 was defined as >180 days after dose 2.
Biological: 2nd dose on time and 3rd dose late
Both doses delayed
A delayed dose 2 was defined as > 90 days after dose 1 and a delayed dose 3 was defined as >180 days after dose 2.
Biological: Both doses late

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV 6 GMT
Time Frame: 1 month following 3rd dose of HPV vaccine
Geometric mean titer (GMT) of antibody to HPV type 6
1 month following 3rd dose of HPV vaccine
HPV 11 GMT
Time Frame: 1 month following 3rd dose of HPV vaccine
Geometric mean titer (GMT) of antibody to HPV type 11
1 month following 3rd dose of HPV vaccine
HPV 16 GMT
Time Frame: 1 month following 3rd dose of HPV vaccine
Geometric mean titer (GMT) of antibody to HPV type 16
1 month following 3rd dose of HPV vaccine
HPV 18 GMT
Time Frame: 1 month following 3rd dose of HPV vaccine
Geometric mean titer (GMT) of antibody to HPV type 18
1 month following 3rd dose of HPV vaccine

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

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014388_1
  • 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.

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