Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)

NCT03000933 | Completed

• 1 other identifier: Merck-54860
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papillomavirus; Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Persistent HPV infection

  Day 7

Study Arms (1)

Young same-sex attracted men

Same-sex attracted men aged 16 to 20

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young same sex attracted men 16-20 years of age in Melbourne, Australia

You may qualify if:

• 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)

You may not qualify if:

• Transgender male

Sponsors & Collaborators

• The Alfred: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

Location

Related Publications (2)

• 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.

  PMID: 34043963 RESULT

• 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):323-329. doi: 10.1093/cid/ciab1052.

  PMID: 34971362 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

1. Oral sampling for HPV 2. Anal sampling for HPV\& 3. Penile sampling for HPV 4. Blood for HPV, HIV, Syphilis 5. Anal swabs for rectal gonorrhoea and chlamydia 6. Pharyngeal swabs for gonorrhoea and chlamydia 7. Urine sample for gonorrhoea and chlamydia Oral, penile, and anal specimens will be collected from each man at two visits 7 days apart. Routine HIV and STI (chlamydia, gonorrhoea, and syphilis) screening will be performed at baseline (Day 0).

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 22, 2016
• Study Start: January 16, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)