Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)

Human Papillomavirus Infection Clinical Trial

— HYPER2  

Official title:

Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000933
• Other study ID #: Merck-54860
• Status: Completed
• Start date: January 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2022
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Transgender male

Related Conditions & MeSH terms

• Human Papillomavirus
• Human Papillomavirus Infection
• Infections
• Papillomavirus Infections

Locations

Country	Name	City	State
Australia	Melbourne Sexual Health Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The Alfred	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Australia, 

References & Publications (2)

Chow 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):323-32 — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Day 7