Impact of HPV Vaccine On The Prevalence Of HPV In Norway

Completed

• Conditions: Cervical Intraepithelial Neoplasia; Oropharyngeal Cancer; Cervical Cancer
• Interventions: Procedure: Self sample from vagina; Procedure: Self sample from the oral cavity; Other: Questionnaire

• Registration Number: NCT02934724
• Lead Sponsor: Oslo University Hospital

Brief Summary

The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.

Detailed Description

This cohort is amongst the first that was offered HPV vaccine in an organized vaccination programme globally. The women will be recruited through Facebook ads. The study will enable us to measure differences in the prevalence of HPV types in vagina and the mouth between vaccinated and non-vaccinated young women in Norway.

The womens vaccination status will be validated by linkage to the Norwegian Immunisation Registry (SYSVAK) and their residence status will be validated through linkage to the Norwegian Population Registry.

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Study Start: 2016-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 315

Inclusion Criteria

• Female
• Born in 1997
• Resident of Norway in 2009

Exclusion Criteria

• Male
• Born before or after 1997
• Non-resident of Norway in 2009

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated	Self sample from the oral cavity	Women born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine. Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire
Vaccinated	Questionnaire	Women born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine. Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire
Un-vaccinated	Self sample from vagina	Women born in 1997, resident to Norway in 2009, not vaccinated by the quadrivalent HPV vaccine Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire
Un-vaccinated	Questionnaire	Women born in 1997, resident to Norway in 2009, not vaccinated by the quadrivalent HPV vaccine Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire
Vaccinated	Self sample from vagina	Women born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine. Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire
Un-vaccinated	Self sample from the oral cavity	Women born in 1997, resident to Norway in 2009, not vaccinated by the quadrivalent HPV vaccine Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire

Primary Outcome Measures

Name	Time	Method
Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence	Within 2 months after self-collection of specimens	The differences in HPV types prevalence among vaccinees and non-vaccinees. HPV types will be assessed individually and combined.

Secondary Outcome Measures

Name	Time	Method
Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants	Within 2 months after self-collection of specimens

Trial Locations

Locations (1)

Oslo University Hospital, Cancer Registry of Norway; 🇳🇴 Oslo, Norway