Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Eisenhower Army Medical Center
ClinicalTrials.gov Identifier:
NCT00501189
First received: July 12, 2007
Last updated: August 1, 2008
Last verified: July 2008
  Purpose

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 Intervention
Papillomavirus Infections
Biological: human papillomavirus vaccine L1, type 6,11,16,18

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

Resource links provided by NLM:


Further study details as provided by Eisenhower Army Medical Center:

Estimated Enrollment: 300
Study Start Date: August 2007
Estimated Study Completion Date: July 2009
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501189

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

No publications provided

Responsible Party: Dean A. Seehusen/PI, Eisenhower Army Medical Center
ClinicalTrials.gov Identifier: NCT00501189     History of Changes
Other Study ID Numbers: DDEAMC 07-43X
Study First Received: July 12, 2007
Last Updated: August 1, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infection
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014