Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

August 1, 2008 updated by: Eisenhower Army Medical Center

This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group.

Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is looking for additional clinical outcomes in women who are already getting the Gardasil vaccination. We are not giving the vaccination as part of the research protocol. This point will be stressed to patients. Their participation or non-participation will not impact their ability to receive the vaccine series. Their participation only impacts whether or not we will contact them in the future and whether or not we will review their medical records.

Subjects will be enrolled into the study at the time of their presentation for colposcopy in the EAMC Family Medicine Clinic. Subjects will be screened for inclusion and exclusion criteria. Those found eligible will be consented for enrollment by one of the study investigators. Colposcopy records will also be searched for patients seen in the colposcopy clinic between the availability of Gardasil and the beginning of this study. Any patients who meet enrollment criteria will be contacted by phone and invited to participate in the study. These patients will be followed in the exact same way as patients enrolled upon presenting for the first time to the colposcopy clinic.

Patients will be given their first vaccination at the time of their colposcopy appointment unless they have already begun the vaccine series. Phone and email will be used to remind patients when they are due for their second and third vaccinations. Any study subject that does not receive the their 2nd or 3rd vaccine will be considered "partially vaccinated". They will not be removed from the protocol, however, because an intention-to-treat analysis is planned.

Study subjects will be followed prospectively for up to 15 months. 15 months was chosen because some patients may be late getting their one-year follow ups. AHLTA records and colposcopy clinic convenience files will be reviewed for each patient periodically. Patients who meet criteria to return to routine annual Pap smear, based on ASCCP guidelines, during the next 11 to 15 months will be considered as "reversion". Those patients who have ASCUS, + HPV, LGSIL, or HGSIL on Pap smear at 11 to 15 months past their original Pap smear will be considered "persistent". Historical control subjects will also be grouped into "reversion" and "persistent" using the same criteria.

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Georgia
      • Fort Gordon, Georgia, United States, 30509
        • Eisenhower Army Medical Center

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

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing colpo for initial low grade Pap abnormality who have elected to under Gardasil vaccination.

Description

Inclusion Criteria:

  • Women between 18 and 26 years of age
  • Women able to consent for themselves
  • Referring Pap smear was ASCUS, + HPV or LGSIL
  • Women who decide they wish to get the Gardasil vaccination series

Exclusion Criteria:

  • Women who have had previous cryotherapy of the cervix, LEEP or cervical conization
  • Women who had their first Gardasil injection prior to their referring Pap smear
  • Women under the age of 18
  • Women unable to consent for themselves
  • Women who are pregnant currently trying to conceive
  • Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc)
  • Women who do not want the Gardasil vaccination series

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
1
Those getting Gardasil vaccination for low grade Pap abnormality.
Biological: human papillomavirus vaccine L1, type 6,11,16,18
Subjects are those getting gradasil vaccination already. This is really not an intervention
2
Historical group that did not get Gardasil.

Collaborators and Investigators

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

Sponsor

Eisenhower Army Medical Center

Investigators

  • Principal Investigator: Dean A. Seehusen, MD, MPH, Eisenhower Army Medical Center

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

August 1, 2007

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

August 4, 2008

Last Update Submitted That Met QC Criteria

August 1, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDEAMC 07-43X

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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