Clinical trial NCT03747770: Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand
Official title: A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: CERVARIX
Urine
DNA PCR
HPV infection
HPV genotyping
Effectiveness
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2018-11-20
Enrollment: 18000
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Age range of subjects: 13 up to 18 years of age

* Vaccination - grade 8: 13 to less than 15 years of age
* Behavioral questionnaire: grade 8 (as above) and 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination
* Urine collection: 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination
* Blood collection: grade 8 (as above) and 15-18 years of age for Year 2 and Year 4 cross-sectional surveys post vaccination
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HPV infection prevalence
timeFrame: Baseline survey (unvaccinated students) during the first year of the study
measure: HPV infection prevalence
timeFrame: Year 2, two years post vaccination
measure: HPV infection prevalence
timeFrame: Year 4, four years post vaccination
measure: Identification of HPV circulating strains
timeFrame: Baseline survey (unvaccinated students) during the first year of the study
measure: Identification of HPV circulating strains
timeFrame: Year 2, two years post vaccination
measure: Identification of HPV circulating strains
timeFrame: Year 4, four years post vaccination
Secondary outcomes:
measure: HPV type-specific antibody response prior and post vaccination
timeFrame: Prior vaccination and at Year 2 and Year 4 Post vaccination
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ministry of Public Health
state: Chang Wat Nonthaburi
Study officials:
affiliation: Department of Disease Control, Thailand Ministry of Public Health, Bangkok
name: Suchada Jiamsiri, MD
role: PRINCIPAL_INVESTIGATOR
References: