Human Papillomavirus Infection
Conditions
Keywords
Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections, Human papillomavirus vaccine, Human papillomavirus (HPV), non inferiority
Brief 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.
Detailed 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.
Interventions
BIOLOGICALGardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Sponsors
Merck Sharp & Dohme LLC
NGO Via Libre
Universidad Peruana Cayetano Heredia
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to HPV Vaccine for HPV 6,11,16,18. | Month 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. |
| 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. | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers | Baseline | Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing. |
| Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers | Month 0 | 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. |
Countries
Peru
Participant flow
Recruitment details
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.
Pre-assignment details
Some eligible participants provided a false phone number, did not show up for their study appointment, refused to use birth control when receiving vaccine doses, and reported not having time to participate in the study. After the survey and Pap smear, vaccination was the final step in study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Regular Schedule Duration: 0,2,6 months | 100 |
| Modified Schedule Duration: 0,3,6 months | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 |
Baseline characteristics
| Characteristic | Modified Schedule | Regular Schedule | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 100 Participants | 200 Participants |
| Age Continuous | 22.97 years STANDARD_DEVIATION 2.17 | 22.86 years STANDARD_DEVIATION 2.33 | 22.92 years STANDARD_DEVIATION 3.18 |
| Region of Enrollment Peru | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 200 | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
Primary
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
Population: All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Regular Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV 6 | 1086.49 Milli Merck Units |
| Regular Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV11 | 745.06 Milli Merck Units |
| Regular Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV16 | 3235.89 Milli Merck Units |
| Regular Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV18 | 603.39 Milli Merck Units |
| Modified Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV18 | 531.66 Milli Merck Units |
| Modified Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV 6 | 1054.13 Milli Merck Units |
| Modified Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV16 | 2704.62 Milli Merck Units |
| Modified Schedule | Antibody Response to HPV Vaccine for HPV 6,11,16,18. | HPV11 | 776.84 Milli Merck Units |
Comparison: The null hypothesis is that both schedules will provide an equivalent antibody response.p-value: >0.2Regression, Logistic
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.
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
Population: All participants were included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regular 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 participants |
| 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. | 93 participants |
Comparison: Completion rates compared in the 2 study armsp-value: 0.6Chi-squared
Secondary
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
Population: All participants who listed doubts about the vaccine are counted here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regular Schedule | Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers | 26 participants |
| Modified Schedule | Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers | 20 participants |
Secondary
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
Population: All participants were included in the analysis for baseline HPV DNA prevalence
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regular Schedule | Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers | 21 participants |
| Modified Schedule | Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers | 25 participants |
Comparison: comparison of differences in HPV DNA prevalence by study arm.p-value: 0.53Chi-squared