Status:
COMPLETED
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Merck Sharp & Dohme LLC
NGO Via Libre
Conditions:
Human Papillomavirus Infection
Eligibility:
FEMALE
18-26 years
Phase:
PHASE4
Brief Summary
The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objecti...
Detailed Description
FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives...
Eligibility Criteria
Inclusion
- Between the age of 18 and 26 years
- Registered female sex worker living in Lima
- Healthy with no known immune deficiency
- Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
- Willing to provide informed consent
Exclusion
- Currently pregnant or planning to get pregnant in the next six months
- Known immune deficiency disorder
- Current receipt of immunosuppressive drugs
- Allergy to yeast or known contraindication to HPV vaccine
- Women who have had their cervix removed
- Previous HPV vaccination
- Current fever over 100 degrees Fahrenheit
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00925288
Start Date
October 1 2009
End Date
August 1 2011
Last Update
October 11 2012
Active Locations (1)
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1
NGO Via Libre
Lima, Lima Province, Peru