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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 4

Conditions: Human Papillomavirus Infection

Treatments: Biological: Gardasil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00925288

IRB00001625

Merck IISP 35706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Regular schedule

Active Comparator group

Description:

Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months

Treatment:

Biological: Gardasil

Modified Schedule

Experimental group

Description:

Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months

Treatment:

Biological: Gardasil