Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501189
Recruitment Status : Unknown
Verified July 2008 by Eisenhower Army Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : July 16, 2007
Last Update Posted : August 4, 2008
Information provided by:
Eisenhower Army Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Papillomavirus Infections Biological: human papillomavirus vaccine L1, type 6,11,16,18

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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Study Start Date : August 2007
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Historical group that did not get Gardasil.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing colpo for initial low grade Pap abnormality who have elected to under Gardasil vaccination.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501189

United States, Georgia
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30509
Sponsors and Collaborators
Eisenhower Army Medical Center
Principal Investigator: Dean A. Seehusen, MD, MPH Eisenhower Army Medical Center

Responsible Party: Dean A. Seehusen/PI, Eisenhower Army Medical Center Identifier: NCT00501189     History of Changes
Other Study ID Numbers: DDEAMC 07-43X
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: July 2008

Keywords provided by Eisenhower Army Medical Center:
Human Papilloma Virus
Papanicolaou Smear
Human Papilloma Virus Vaccine
Human Papillomavirus Infection

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Immunologic Factors
Physiological Effects of Drugs