Phase 4
N=200
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Human Papillomavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT00925288 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Antibody Response to HPV Vaccine for HPV 6,11,16,18. — 1086.49; 1054.13; 745.06; 776.84 Milli Merck Units — p=>0.20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gardasil (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Response to HPV Vaccine for HPV 6,11,16,18. |
1086.49; 1054.13; 745.06; 776.84; 3235.89; 2704.62 | >0.20 |
| PRIMARY 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. |
91; 93 | 0.60 |
| SECONDARY Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers |
21; 25 | 0.53 |
| SECONDARY Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers |
26; 20 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00925288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.