PROGRESS study
Research type
Research Study
Full title
PRevalence of Oral hpv infection, a Global aSSessment. The PROGRESS Study
IRAS ID
297700
Contact name
Thomas Dietrich
Contact email
Sponsor organisation
Merck Sharp & Dohme UK Limited
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Summary of Research
Human papillomavirus (HPV) infections are associated with lesions in the anogenital as well as the head and neck areas. More than 200 genotypes of HPV have been identified; some are low-risk and some are high-risk, and may cause cancers such as cervical, vaginal, vulvar, anal, or head and neck cancers.HPV is a common infection in the general population. Recent data estimates the prevalence of oral HPV infection is 6.5% in Europe and, 5.1% in the US. Some risk factors for HPV-positive head and neck carcinomas reported in the literature are a high number of oral sexual partners, tobacco use, and previous exposure to radiation.
The information on oral HPV prevalence is limited across the world, and some aspects of the natural history of the HPV-related head and neck disease are still uncertain, with large data gaps. Complementary data is needed for future surveillance on head and neck cancers.This study aims to gather more information on the natural history especially regarding the prevalence of oral HPV in the general population in France, Germany, Spain, the United Kingdom (UK), and the United States (US).
In the UK, about 1,164 healthy adult participants visiting their dentists across 17 dental clinics (in primary and secondary care) will be enrolled in the study. Participants would be consented prior to collection of oral rinse and gargle samples, the specimen would be investigated for the presence of HPV. Participants would also be asked to complete a questionnaire that assesses risk factors.
Summary of Results
The PROGRESS study, titled "PRevalence of Oral hpv infection, a Global aSSessment,"The research aimed to understand the prevalence and the distribution of variation types (genotype distribution) of oral human papillomavirus (HPV) infection in the UK, as it is a leading cause of some head and neck cancers (HNC). The called high risk (HR) HPV are genotypes that present higher risk of causing cancers, being HPV-16 the most common HR genotype. The main questions studied were the prevalence of oral HPV infection and its association with factors such as age, sex, oral health, and sexual behavior. Participants did not receive any treatments or interventions as part of the study. Participants completed behavioral questionnaires, provided oral rinse and gargle specimens, and had their oral health assessed by dentists.
This study includes a representative sample of healthy adults from across the UK (dental sites in England representing 7 out of 9 administrative regions) with comprehensive oral health data from dental examinations and detailed HPV DNA data on HPV infections. The research took place in the UK between September 2022 and April 2023 and involved 1096 participants aged 18-60 from 17 dental practices across the UK.
The study found that, of 1096 participants, 53.8% were women and the mean age was 44.3 years. Point prevalence of any HPV genotypes, HR HPV genotypes, HPV genotypes included on the 9 valent vaccine, and HPV-16 genotype was 9.9, 2.7%, 1.6% and 0.8%, respectively. Prevalence was stratified by age and sex. Compared with women, men had higher prevalence of any HPV (14.0% vs 6.4%) and HR-HPV (5.0% vs 1.3%). Prevalence of any and HR-HPV was highest among men aged 51-60 (21.7%) and 41-50 (7.9%). HR-HPV prevalence was significantly higher among participants with periodontitis/gingivitis (5.7% vs 1.2% among those without) and those with >26 lifetime female oral sex partners (11.1% vs 4.6% among those with 1-5 partners).
Oral HPV prevalence estimates are broadly consistent with published literature from England and Scotland. Results demonstrated oral HR-HPV to be most prevalent in men older than 40, in line with existing literature demonstrating increased HPV-driven oropharyngeal cancer in this cohort. In addition to commonly reported risk factors such as sex, age, and smoking status, the study highlights the potential impact of oral health on oral HPV infection which is less well documented or understood.
The study has provided valuable insights into the prevalence and risk factors associated with oral HPV infection in the UK. It highlights the need for increased HPV prevention efforts among boys and men and continued vaccination among women.
You can learn more about the study by accessing the global study results and the study protocol available online.
Global study results including UK data can be found on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1016%252Fj.eclinm.2024.103018%2FNBTI%2Fe_C6AQ%2FAQ%2F5982a758-44db-4e6d-992d-dccfec0cc811%2F1%2FUHt1Bs2nwO&data=05%7C02%7Capprovals%40hra.nhs.uk%7C66b95168298e46702a2508dd3b1c5aa2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638731715157564405%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=d3r51Er2PP8rCVENKQcxYp9zB9w%2F21GZegs6vWiy1zc%3D&reserved=0
A description of the study design can be found on 10.1016/j.cct.2021.106630The study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
22/ES/0018
Date of REC Opinion
20 Jun 2022
REC opinion
Further Information Favourable Opinion