A Phase 4 interventional study of Gardasil in Human Papillomavirus Infection, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Peru. Open to female participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 4, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
Biological: Gardasil
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
Also known as: Human Papillomavirus Quadrivalent Vaccine
Antibody Response to HPV Vaccine for HPV 6,11,16,18.
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.
Time frame: 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.
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.
Time frame: 6 months
Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers
Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
Time frame: Baseline
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers
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.
Time frame: Month 0
FSWs 18-26 years of age were recruited in person between August 28, 2009 and March 3, 2010 from 49 different sex locales in Lima, Peru by trained medical staff and 8 health promoters. If they fulfilled inclusion criteria, women were asked to report to the study clinic for completion of surveys, vaccination, Pap smears, and counseling.
| Milestone | Regular Schedule | Modified Schedule |
|---|---|---|
| Started | 100 | 100 |
| Completed | 91 | 93 |
| Not completed | 9 | 7 |
| Withdrew: Lost to follow-up | 9 | 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.
| Milli Merck Units | Regular Schedule | Modified Schedule |
|---|---|---|
| HPV 6 | 1086.49 (854.16 to 1382.0) | 1054.13 (808.42 to 1374.53) |
| HPV11 | 745.06 (588.82 to 942.76) | 776.84 (644.03 to 936.21) |
| HPV16 | 3235.89 (2661.93 to 3933.61) | 2704.62 (2301.71 to 3178.06) |
| HPV18 | 603.39 (487.81 to 746.35) | 531.66 (441.68 to 639.97) |
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.
| participants | Regular Schedule | Modified Schedule |
|---|---|---|
| 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 |
Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
| participants | Regular Schedule | Modified Schedule |
|---|---|---|
| Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers | 21 | 25 |
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.
| participants | Regular Schedule | Modified Schedule |
|---|---|---|
| Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers | 26 | 20 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regular Schedule | — | 0/200 (0%) | 0/200 (0%) |
| Modified Schedule | — | 0/200 (0%) | 0/200 (0%) |
| Age, Categorical(Participants) | Regular Schedule | Modified Schedule | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 100 | 100 | 200 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Regular Schedule | Modified Schedule | Total |
|---|---|---|---|
| Mean | 22.86 ± 2.33 | 22.97 ± 2.17 | 22.92 ± 3.18 |
| Sex: Female, Male(Participants) | Regular Schedule | Modified Schedule | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Regular Schedule | Modified Schedule | Total |
|---|---|---|---|
| Peru | 100 | 100 | 200 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health