CompletedPhase 4

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

Peru200 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range18 Years – 26 Years

SexFEMALE

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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

What they're measuring

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

Timeframe: Month 7

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.

Timeframe: 6 months

Trial details

NCT IDNCT00925288

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2012-07-03

View on ClinicalTrials.gov More Human Papillomavirus Infection trials