Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

NCT00501189 | Withdrawn

• 1 other identifier: DDEAMC 07-43X
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillomavirus Infections

Keywords

Gardasil; Human Papilloma Virus; Papanicolaou Smear; ASCUS; LGSIL; Human Papilloma Virus Vaccine; Human Papillomavirus Infection

Study Arms (2)

1

Those getting Gardasil vaccination for low grade Pap abnormality.

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

2

Historical group that did not get Gardasil.

Interventions

human papillomavirus vaccine L1, type 6,11,16,18 BIOLOGICAL

Subjects are those getting gradasil vaccination already. This is really not an intervention

1

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisenhower Army Medical Center: lead

Study Sites (1)

Eisenhower Army Medical Center

Fort Gordon, Georgia, 30509, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Atypical Squamous Cells of the Cervix

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Dean A. Seehusen, MD, MPH

  Eisenhower Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2009
• Last Updated: June 11, 2024

Record last verified: 2008-07

Locations

US (1)