Clinical trial NCT00501189: Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Official title: Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Papillomavirus Infections
Keywords: Gardasil
Human Papilloma Virus
Papanicolaou Smear
ASCUS
LGSIL
Human Papilloma Virus Vaccine
Human Papillomavirus Infection
Lead sponsor: Eisenhower Army Medical Center
Sponsor class: FED
First posted: 2007-07-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing colpo for initial low grade Pap abnormality who have elected to under Gardasil vaccination.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Gordon
country: United States
facility: Eisenhower Army Medical Center
state: Georgia
Study officials:
affiliation: Eisenhower Army Medical Center
name: Dean A. Seehusen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: