Human PapillomavirusHYPER2NCT03000933
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)
An observational study of Human Papillomavirus and Human Papillomavirus Infection, run by The Alfred at 1 site in Australia.
Trial summary
Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination. Read more about this study
- Who is it for?
- Ages 16 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus, Human Papillomavirus Infection
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jan 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Young same sex attracted men 16-20 years of age in Melbourne, Australia
Who may be able to join
- Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)
- Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever
- Able to complete all study requirements including questionnaire in English and completion of 2 visits
- Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)
Who cannot join
- Transgender male
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia
Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.
Read the detailed description
HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.
This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young same-sex attracted men | Same-sex attracted men aged 16 to 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of quadrivalent vaccine HPV types
The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.
Measured: Baseline
Secondary outcomes (1)
Persistent HPV infection
Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start16 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Eric Chow, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000933
- Sponsor's protocol ID
- Merck-54860
- Acronym
- HYPER2
- Status last verified
- Oct 2022
- First submitted
- 19 Dec 2016
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.
PubMed 34043963Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052.
PubMed 34971362
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia
- ClinicalTrials.gov ID
- NCT03000933
- Acronym / sponsor ID
- HYPER2 / Merck-54860
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.
Detailed description
HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.
This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young same-sex attracted men | – | –Same-sex attracted men aged 16 to 20 |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young same sex attracted men 16-20 years of age in Melbourne, Australia
Key inclusion criteria (4 listed)
- Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)
- Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever
- Able to complete all study requirements including questionnaire in English and completion of 2 visits
- Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)
Key exclusion criteria (1 listed)
- Transgender male
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 quadrivalent vaccine HPV types
Time frame: Baseline
The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.
1 secondary outcome
Persistent HPV infection
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Results publication: PubMed 34043963Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.
- Results publication: PubMed 34971362Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Human Papillomavirus Infection, 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 5 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 quadrivalent vaccine HPV types (time frame: Baseline). 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 NCT03000933, which also lists 2 linked publications.
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 5 Oct 2022.