Trial Outcomes & Findings for Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers (NCT NCT00925288)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Month 7

Results posted on

2012-10-11

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Regular Schedule Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age	Modified Schedule Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
Overall Study STARTED	100	100
Overall Study COMPLETED	91	93
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Regular Schedule Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age	Modified Schedule Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
Overall Study Lost to Follow-up	9	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regular Schedule n=100 Participants Duration: 0,2,6 months	Modified Schedule n=100 Participants Duration: 0,3,6 months	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	22.86 years STANDARD_DEVIATION 2.33 • n=5 Participants	22.97 years STANDARD_DEVIATION 2.17 • n=7 Participants	22.92 years STANDARD_DEVIATION 3.18 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Peru	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Regular Schedule n=89 Participants Duration: 0,2,6 months	Modified Schedule n=93 Participants Duration: 0,3,6 months
Antibody Response to HPV Vaccine for HPV 6,11,16,18. HPV 6	1086.49 Milli Merck Units Interval 854.16 to 1382.0	1054.13 Milli Merck Units Interval 808.42 to 1374.53
Antibody Response to HPV Vaccine for HPV 6,11,16,18. HPV11	745.06 Milli Merck Units Interval 588.82 to 942.76	776.84 Milli Merck Units Interval 644.03 to 936.21
Antibody Response to HPV Vaccine for HPV 6,11,16,18. HPV16	3235.89 Milli Merck Units Interval 2661.93 to 3933.61	2704.62 Milli Merck Units Interval 2301.71 to 3178.06
Antibody Response to HPV Vaccine for HPV 6,11,16,18. HPV18	603.39 Milli Merck Units Interval 487.81 to 746.35	531.66 Milli Merck Units Interval 441.68 to 639.97

PRIMARY outcome

Timeframe: 6 months

Population: All participants were included

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.

Outcome measures

Outcome measures
Measure	Regular Schedule n=100 Participants Duration: 0,2,6 months	Modified Schedule n=100 Participants Duration: 0,3,6 months
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	93 participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants were included in the analysis for baseline HPV DNA prevalence

Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.

Outcome measures

Outcome measures
Measure	Regular Schedule n=99 Participants Duration: 0,2,6 months	Modified Schedule n=100 Participants Duration: 0,3,6 months
Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers	21 participants	25 participants

SECONDARY outcome

Timeframe: Month 0

Population: All participants who listed doubts about the vaccine are counted here.

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.

Outcome measures

Outcome measures
Measure	Regular Schedule n=100 Participants Duration: 0,2,6 months	Modified Schedule n=100 Participants Duration: 0,3,6 months
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers	26 participants	20 participants

Adverse Events

Regular Schedule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modified Schedule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brandon Brown

Johns Hopkins University

Phone: 949-266-4401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place