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

International Vaccine Institute18,000 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Healthy

Interventions

Bivalent HPV vaccine CERVARIX®BIOLOGICAL

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)

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ministry of Public Health

Bangkok, Chang Wat Nonthaburi, Thailand

Outcomes

Primary Outcomes

HPV infection prevalence

HPV DNA PCR in urine

Time frame: Baseline survey (unvaccinated students) during the first year of the study

HPV infection prevalence

HPV DNA PCR in urine

Time frame: Year 2, two years post vaccination

HPV infection prevalence

HPV DNA PCR in urine

Time frame: Year 4, four years post vaccination

Identification of HPV circulating strains

HPV genotyping on urine positive samples

Time frame: Baseline survey (unvaccinated students) during the first year of the study

Identification of HPV circulating strains

HPV genotyping on urine positive samples

Time frame: Year 2, two years post vaccination

Identification of HPV circulating strains

HPV genotyping on urine positive samples

Time frame: Year 4, four years post vaccination

Secondary Outcomes

HPV type-specific antibody response prior and post vaccination

Blood Sample

Time frame: Prior vaccination and at Year 2 and Year 4 Post vaccination

Data from ClinicalTrials.gov

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