Trial Outcomes & Findings for Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination (NCT NCT02003508)
NCT ID: NCT02003508
Last Updated: 2020-03-06
Results Overview
Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array. Participants provided a single penile sample.
COMPLETED
345 participants
Single study visit (one time point per participant)
2020-03-06
Participant Flow
Participants were recruited from clinical and community sources across Australia over a period of four years (February 2014- December 2017), which represented two phases. Participants recruited in phase 1 (2014-2015) were ineligible for school-based HPV vaccination. Participants in Phase 2(2016-2017) were eligible for school-based HPV vaccination.
Participant milestones
| Measure |
Phase 1 (2014-2015)
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. Accordingly, most of these men were unvaccinated against 4HPV.
|
Phase 2 (2016-2017)
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction. Accordingly, many participants in this group had received the HPV vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
166
|
|
Overall Study
COMPLETED
|
179
|
166
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pre-vaccination Period
n=179 Participants
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program.
|
Post-vaccination Period
n=166 Participants
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.5 years
n=179 Participants
|
18.3 years
n=166 Participants
|
18.4 years
n=345 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=179 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=345 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=179 Participants
|
166 Participants
n=166 Participants
|
345 Participants
n=345 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Australia
|
179 participants
n=179 Participants
|
166 participants
n=166 Participants
|
345 participants
n=345 Participants
|
|
Sexual contact in lifetime
|
179 Participants
n=179 Participants
|
166 Participants
n=166 Participants
|
345 Participants
n=345 Participants
|
PRIMARY outcome
Timeframe: Single study visit (one time point per participant)Population: All participants in group one were ineligible for school-based vaccination. All participants in group two were eligible to receive 4vHPV vaccination. All participants had experienced sexual contact with a female (either oral or vaginal sex), no sexual contact (either oral or anal sex) with a male, and had assessable penile samples.
Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array. Participants provided a single penile sample.
Outcome measures
| Measure |
Phase 1 (2014-2015)
n=152 Participants
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program.
|
Phase 2 (2016-2017)
n=146 Participants
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction
|
|---|---|---|
|
Prevalence of Penile HPV Genotypes
Any 4vHPV vaccine genotype
|
2.6 percentage of participants
Interval 0.7 to 6.6
|
0.7 percentage of participants
Interval 0.0 to 3.8
|
|
Prevalence of Penile HPV Genotypes
Any of 37 HPV genotypes
|
21.7 percentage of participants
Interval 15.4 to 29.1
|
11.6 percentage of participants
Interval 6.9 to 18.0
|
|
Prevalence of Penile HPV Genotypes
Any of 13 high-risk genotypes, other than 16 and 1
|
15.1 percentage of participants
Interval 9.8 to 21.8
|
7.5 percentage of participants
Interval 3.8 to 13.1
|
Adverse Events
Phase 1 (2014-2015)
Phase 2 (2016-2017)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place