Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand (IVIHPV1)

A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy
• Intervention / Treatment: Biological: Bivalent HPV vaccine CERVARIX®

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 Type: Interventional
• Enrollment (Anticipated): 18000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chang Wat Nonthaburi
    • Bangkok, Chang Wat Nonthaburi, Thailand, 11000
      • Ministry of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria

A. Grade 8 (Mathayom 2):

1. Female students with identification card
2. Less than 15 years of age
3. Parent or guardian consent for vaccination and blood collection as applicable Participant assent for vaccination, questionnaire, and blood collection as applicable

B. Baseline survey (Grade 10 / year 1, Grade 12 / year 3)

1. Female students with identification card Participant assent for questionnaire and urine collection

C. Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)

1. Female students with identification card
2. Parent or guardian consent for blood collection as applicable
3. Participant assent for questionnaire, urine and blood collection from those vaccinated at Grade 8 as applicable

Exclusion criteria

A. Grade 8 (Mathayom 2):

1. Students who already received HPV vaccination
2. Reported pregnancy
3. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing

B. Baseline survey (Grade 10 / year 1, Grade 12 / year 3) 1. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing

C. Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)

1. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Cross-sectional baseline survey; This are will collect behavioral questionnaire and urine in Grade 10 high school and Year 1 vocational school and Grade 12 high school and Year 3 Vocational school female students
ACTIVE_COMPARATOR: Single Dose HPV vaccination; 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)	Biological: Bivalent HPV vaccine CERVARIX®; Bivalent HPV vaccine(Glaxo Smith Kline, GSK, Rixensart, Belgium) presented as a suspension for intramuscular injection containing purified viral L1 protein for HPV types 16 and 18. Each 0.5 mL dose of the bivalent vaccine contains 20μg of HPV-16 L1 protein and 20 μg of HPV-18 L1 protein adsorbed onto a proprietary adjuvant system containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A (AS04)
ACTIVE_COMPARATOR: Two-dose HPV vaccination; 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)	Biological: Bivalent HPV vaccine CERVARIX®; Bivalent HPV vaccine(Glaxo Smith Kline, GSK, Rixensart, Belgium) presented as a suspension for intramuscular injection containing purified viral L1 protein for HPV types 16 and 18. Each 0.5 mL dose of the bivalent vaccine contains 20μg of HPV-16 L1 protein and 20 μg of HPV-18 L1 protein adsorbed onto a proprietary adjuvant system containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A (AS04)
NO_INTERVENTION: Cross-sectional survey at Year 2; This arm will collect behavioral questionnaire, urine and blood in Grade 10 high school and Year 1 vocational school female students
NO_INTERVENTION: Cross-sectional survey at Year 4; Cross-sectional survey at Year 4 post vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV infection prevalence	HPV DNA PCR in urine	Baseline survey (unvaccinated students) during the first year of the study
HPV infection prevalence	HPV DNA PCR in urine	Year 2, two years post vaccination
HPV infection prevalence	HPV DNA PCR in urine	Year 4, four years post vaccination
Identification of HPV circulating strains	HPV genotyping on urine positive samples	Baseline survey (unvaccinated students) during the first year of the study
Identification of HPV circulating strains	HPV genotyping on urine positive samples	Year 2, two years post vaccination
Identification of HPV circulating strains	HPV genotyping on urine positive samples	Year 4, four years post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV type-specific antibody response prior and post vaccination	Blood Sample	Prior vaccination and at Year 2 and Year 4 Post vaccination

Collaborators and Investigators

• Sponsor: International Vaccine Institute
• Collaborators: Ministry of Health, Thailand
• Investigators: Principal Investigator: Suchada Jiamsiri, MD, Department of Disease Control, Thailand Ministry of Public Health, Bangkok

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Urine; Effectiveness; HPV infection; CERVARIX; DNA PCR; HPV genotyping
• Other Study ID Numbers: IVI HPV1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No