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Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

Phase 4
18 Years
26 Years
Not Enrolling
Human Papillomavirus Infection

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Trial Information

Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Antibody Response to HPV Vaccine for HPV 6,11,16,18.

Outcome Description:

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.

Outcome Time Frame:

Month 7

Safety Issue:


Principal Investigator

Neal Halsey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Bloomberg School of Public Health


United States: Institutional Review Board

Study ID:

Merck IISP 35706



Start Date:

October 2009

Completion Date:

August 2011

Related Keywords:

  • Human Papillomavirus Infection
  • Female sex worker
  • Peru
  • Cervical infection
  • Cervical abnormality
  • Serum antibody
  • Vaccine acceptance
  • Alternative schedule
  • Viral infections
  • Human papillomavirus vaccine
  • Human papillomavirus (HPV)
  • non inferiority
  • Warts
  • Papillomavirus Infections