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Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers (Girasol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00925288
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Biological: Gardasil Phase 4

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 evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru
Study Start Date : October 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Regular schedule
Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
Biological: Gardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Other Name: Human Papillomavirus Quadrivalent Vaccine
Experimental: Modified Schedule
Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months
Biological: Gardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Other Name: Human Papillomavirus Quadrivalent Vaccine


Outcome Measures

Primary Outcome Measures :
  1. Antibody Response to HPV Vaccine for HPV 6,11,16,18. [ Time Frame: Month 7 ]
    We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.

  2. Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule. [ Time Frame: 6 months ]
    Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.


Secondary Outcome Measures :
  1. Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers [ Time Frame: Baseline ]
    Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.

  2. Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers [ Time Frame: Month 0 ]
    Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925288


Locations
Peru
NGO Via Libre
Lima, Peru
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Merck Sharp & Dohme Corp.
NGO Via Libre
Universidad Peruana Cayetano Heredia
Investigators
Principal Investigator: Neal Halsey, MD Johns Hopkins Bloomberg School of Public Health
More Information

Publications:

Responsible Party: Neal Halsey, Professor of International Health, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00925288     History of Changes
Other Study ID Numbers: Merck IISP 35706
IRB00001625
First Posted: June 22, 2009    Key Record Dates
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012
Last Verified: September 2012

Keywords provided by Neal Halsey, Johns Hopkins Bloomberg School of Public Health:
Female sex worker
Peru
Cervical infection
Cervical abnormality
Serum antibody
Vaccine acceptance
Alternative schedule
Viral infections
Human papillomavirus vaccine
Human papillomavirus (HPV)
non inferiority

Additional relevant MeSH terms:
Infection
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs