Human PapillomavirusImpressNCT02003508

Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

An observational study of Human Papillomavirus, run by The Alfred at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia. Read more about this study

Who is it for?: Ages 17 to 19 years, men onlyHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus
Type of treatment: Vaccines
How many people: 345 participants
Where: 1 siteAustralia
Study dates: Jan 2014to 29 Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 to 19 years
Men only
Healthy volunteers accepted
Child, Adult

Study population: Males aged 17-19 recruited from sexual health clinics and community sources

Who may be able to join

Male
Aged 17 to 19
Able to complete study requirements
Residing in Australia from 12 years of age

Who cannot join

-Males reporting sex with males in the past 12 months

Trial locations and contacts

1 site in 1 country.

Australia1 site

Melbourne Sexual Health Centre
Melbourne, Victoria, 3053

Other trials in Australia

About this study

This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Read the detailed description

Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Conditions: Human Papillomavirus
Keywords: Prevalence, HPV, Human papillomavirus, Vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02003508
Study group	Role	What they receive
Pre-school based vaccination program (not vaccine eligible)		Young (17-19 years) men who were not eligible for school based vaccination due to their age at the time of the programs roll out.
Post-school based vaccination program (vaccine eligible)		Young men (17-19 years) who were eligible for school based vaccination due to their age at the time of the programs roll out.

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of Penile HPV Genotypes
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.
Measured: Single study visit (one time point per participant)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201429 Dec 2017

First posted6 Dec 2013 (estimated)
Study startJan 2014
Primary completion29 Dec 2017
Study completion29 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human PapillomavirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Ecologic or community
Time perspective: Prospective
Enrolment: 345 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02003508
Sponsor's protocol ID: IISP50939
Acronym: Impress
Status last verified: Mar 2020
First submitted: 2 Dec 2013
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 4
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Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
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RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
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All Human Papillomavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
ClinicalTrials.gov ID: NCT02003508
Acronym / sponsor ID: Impress / IISP50939
Conditions: Human Papillomavirus
Keywords: Prevalence, HPV, Human papillomavirus, Vaccination
Study type: Observational
Recruitment status: Completed
Enrolment: 345 participants (actual)
Lead sponsor: The AlfredUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Jan 2014
Primary completion: 29 Dec 2017 (actual)
Study completion: 29 Dec 2017 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 6 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Detailed description

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pre-school based vaccination program (not vaccine eligible)	–	–Young (17-19 years) men who were not eligible for school based vaccination due to their age at the time of the programs roll out.
Post-school based vaccination program (vaccine eligible)	–	–Young men (17-19 years) who were eligible for school based vaccination due to their age at the time of the programs roll out.

Who may qualify

Ages: 17 to 19 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Males aged 17-19 recruited from sexual health clinics and community sources

Key inclusion criteria (4 listed)

Male
Aged 17 to 19
Able to complete study requirements
Residing in Australia from 12 years of age

Key exclusion criteria (1 listed)

-Males reporting sex with males in the past 12 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Prevalence of Penile HPV Genotypes
Time frame: Single study visit (one time point per participant)
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.

Results and safety

Results posted to the registry on 6 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 (2014-2015)	179	179
Phase 2 (2016-2017)	166	166

Primary outcome: Prevalence of Penile HPV Genotypes

Time frame: Single study visit (one time point per participant). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 1 (2014-2015) n = 152	Phase 2 (2016-2017) n = 146
Any 4vHPV vaccine genotype	2.6 (0.7 to 6.6)	0.7 (0 to 3.8)
Any of 37 HPV genotypes	21.7 (15.4 to 29.1)	11.6 (6.9 to 18.0)
Any of 13 high-risk genotypes, other than 16 and 1	15.1 (9.8 to 21.8)	7.5 (3.8 to 13.1)

Population analysed: 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.

Adverse events

Time frame: Single study visit per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 (2014-2015)	0 of 179 (0%)	0 of 179 (0%)	0 of 179
Phase 2 (2016-2017)	0 of 166 (0%)	0 of 166 (0%)	0 of 166

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Papillomavirus

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcus Y Chen, PhD principal investigator

Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Papillomavirus, run by The Alfred at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Penile HPV Genotypes (time frame: Single study visit (one time point per participant)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02003508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.