Papillomavirus InfectionsNCT00501189
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
An observational study of Papillomavirus Infections, run by Eisenhower Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- human papillomavirus vaccine L1, type 6,11,16,18
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing colpo for initial low grade Pap abnormality who have elected to under Gardasil vaccination.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30509
About this study
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.
Read the 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.
- Conditions
- Papillomavirus Infections
- Being tested
- human papillomavirus vaccine L1, type 6,11,16,18
- Keywords
- Gardasil, Human Papilloma Virus, Papanicolaou Smear, ASCUS, LGSIL, Human Papilloma Virus Vaccine, Human Papillomavirus Infection
- Medical subject headings
- Papillomavirus Infections, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human papillomavirus vaccine L1, type 6,11,16,18Biological
Subjects are those getting gradasil vaccination already. This is really not an intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Those getting Gardasil vaccination for low grade Pap abnormality. Receives: Biological: human papillomavirus vaccine L1, type 6,11,16,18 | |
| 2 | Historical group that did not get Gardasil. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startAug 2007
- Primary completion1 Sep 2007 (estimated)
- Study completionJul 2009
Why it stopped: recruiting issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisenhower Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dean A. Seehusen, Eisenhower Army Medical Center
- Investigators
- Dean A. Seehusen, MD, MPH, Principal investigator, Eisenhower Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501189
- Sponsor's protocol ID
- DDEAMC 07-43X
- Status last verified
- Jul 2008
- First submitted
- 12 Jul 2007
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
- ClinicalTrials.gov ID
- NCT00501189
- Acronym / sponsor ID
- DDEAMC 07-43X
- Conditions
- Papillomavirus Infections
- Keywords
- Gardasil, Human Papilloma Virus, Papanicolaou Smear, ASCUS, LGSIL, Human Papilloma Virus Vaccine, Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: recruiting issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eisenhower Army Medical CenterUS federal agency
- Study start
- Aug 2007
- Primary completion
- 1 Sep 2007 (estimated)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: human papillomavirus vaccine L1, type 6,11,16,18Those getting Gardasil vaccination for low grade Pap abnormality. |
| 2 | – | –Historical group that did not get Gardasil. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing colpo for initial low grade Pap abnormality who have elected to under Gardasil vaccination.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human papillomavirus vaccine L1, type 6,11,16,18Subjects are those getting gradasil vaccination already. This is really not an intervention | Biological | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean A. Seehusen, MD, MPH principal investigator
Eisenhower Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections, run by Eisenhower Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.