Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand

Not Applicable

• Conditions: Healthy
• Interventions: Biological: Bivalent HPV vaccine CERVARIX®

• Registration Number: NCT03747770
• Lead Sponsor: International Vaccine Institute

Brief Summary

This is a community intervention effectiveness study in female school students in Thailand.

The study objectives are:

1. To demonstrate HPV vaccine effectiveness of Single Dose (SD) by a reduction in vaccine-type HPV prevalence (HPV 16 and HPV 18) at Year 2 and Year 4 post vaccination compared to unvaccinated same grade female students

2. To demonstrate that HPV vaccine effectiveness of SD and two-dose (2D) regimens are similar by comparing reductions in vaccine type prevalence at Year 2 and Year 4 post vaccination compared with the baseline surveys in the two provinces

Detailed Description

The study will investigate the effectiveness of a SD of HPV vaccine through the conduct of a regional effectiveness study in Thailand.

The study will be conducted in schools and district hospitals from the two selected provinces (Udon Thani and Buriram)

The study design includes 4 distinct and independent components:

1) vaccination, 2)baseline cross-sectional survey, 3,4)sequential cross-sectional surveys for impact assessments at Year 2 and Year 4 post vaccination.

* Vaccination: The target population is represented by all Grade 8 female students in the two provinces. All enrolled students will receive either SD (Udon Thani) or 2D (Buriram). A subset (N=200/province) of Grade 8 female students in each province will be selected for a blood collection before vaccination for assessment of vaccine immunogenicity.

* Surveys (baseline, Year 2 and Year 4 impact surveys): Target populations of are a subset of female students of Grades 10 High school (HS)/year 1 Vocational School (VS) and Grade 12 HS/year 3 VS from all schools in the two provinces and the sampling unit is an individual. Urine collection will be performed to assess HPV infection by DNA PCR and for genotyping of positive samples. A subset of students (N=200 per province) will be randomly selected for each of the Year 2 and Year 4 surveys for blood collection for assessment of vaccine immunogenicity.

* Demographics and sexual behavior questionnaire will be collected from all students.

Study Timeline

• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-18
• Study First Posted: 2018-11-20
• Study Start: 2018-12-17
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-22
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 18000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose HPV vaccination	Bivalent HPV vaccine CERVARIX®	Grade 8 female students from Udon Thani Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Single Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium)
Two-dose HPV vaccination	Bivalent HPV vaccine CERVARIX®	Grade 8 female students from Buriram Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Two-Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium)

Primary Outcome Measures

Name	Time	Method
HPV infection prevalence	Year 4, four years post vaccination	HPV DNA PCR in urine
Identification of HPV circulating strains	Year 4, four years post vaccination	HPV genotyping on urine positive samples

Secondary Outcome Measures

Name	Time	Method
HPV type-specific antibody response prior and post vaccination	Prior vaccination and at Year 2 and Year 4 Post vaccination	Blood Sample

Trial Locations

Locations (1)

Ministry of Public Health; 🇹🇭 Bangkok, Chang Wat Nonthaburi, Thailand