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

International Vaccine Institute (IVI)

Status: Unknown

Conditions: Healthy

Treatments: Biological: Bivalent HPV vaccine CERVARIX®

Study type: Interventional

Funder types: Other

Identifiers

NCT03747770

IVI HPV1

Details and patient eligibility

About

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

Full 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.

Enrollment: 18,000 estimated patients

Sex: Female

Ages: 13 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18,000 participants in 5 patient groups

Cross-sectional baseline survey

No Intervention group

Description:

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

Single Dose HPV vaccination

Active Comparator group

Description:

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)

Treatment:

Biological: Bivalent HPV vaccine CERVARIX®

Two-dose HPV vaccination

Active Comparator group

Description:

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)

Treatment:

Biological: Bivalent HPV vaccine CERVARIX®

Cross-sectional survey at Year 2

No Intervention group

Description:

This arm will collect behavioral questionnaire, urine and blood in Grade 10 high school and Year 1 vocational school female students

Cross-sectional survey at Year 4

No Intervention group

Description:

Cross-sectional survey at Year 4 post vaccination