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

Healthy Clinical Trial

— IVIHPV1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03747770
• Other study ID #: IVI HPV1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: June 2023

Study information

• Verified date: April 2020
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18000
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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)

Locations

Country	Name	City	State
Thailand	Ministry of Public Health	Bangkok	Chang Wat Nonthaburi

Sponsors (2)

Lead Sponsor	Collaborator
International Vaccine Institute	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV infection prevalence	HPV DNA PCR in urine	Baseline survey (unvaccinated students) during the first year of the study
Primary	HPV infection prevalence	HPV DNA PCR in urine	Year 2, two years post vaccination
Primary	HPV infection prevalence	HPV DNA PCR in urine	Year 4, four years post vaccination
Primary	Identification of HPV circulating strains	HPV genotyping on urine positive samples	Baseline survey (unvaccinated students) during the first year of the study
Primary	Identification of HPV circulating strains	HPV genotyping on urine positive samples	Year 2, two years post vaccination
Primary	Identification of HPV circulating strains	HPV genotyping on urine positive samples	Year 4, four years post vaccination
Secondary	HPV type-specific antibody response prior and post vaccination	Blood Sample	Prior vaccination and at Year 2 and Year 4 Post vaccination