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

NCT03747770 | Unknown DMC

• 1 other identifier: IVI HPV1
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a community intervention effectiveness study in female school students in Thailand. The study objectives are:

1. 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. 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

Conditions

Healthy

Keywords

CERVARIX; Urine; DNA PCR; HPV infection; HPV genotyping; Effectiveness

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• HPV type-specific antibody response prior and post vaccination

  Prior vaccination and at Year 2 and Year 4 Post vaccination

Study Arms (5)

Cross-sectional baseline survey

NO INTERVENTION

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

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®

Two-dose HPV vaccination

ACTIVE COMPARATOR

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®

Cross-sectional survey at Year 2

NO INTERVENTION

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

Cross-sectional survey at Year 4 post vaccination

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)

Single Dose HPV vaccination; Two-dose HPV vaccination

Eligibility Criteria

• Age: 13 Years - 15 Years
• Gender Eligibility Details: Female students
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A. Grade 8 (Mathayom 2):
• Female students with identification card
• Less than 15 years of age
• 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)
• \. 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)
• Female students with identification card
• Parent or guardian consent for blood collection as applicable
• Participant assent for questionnaire, urine and blood collection from those vaccinated at Grade 8 as applicable

You may not qualify if:

• A. Grade 8 (Mathayom 2):
• Students who already received HPV vaccination
• Reported pregnancy
• 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)
• \. 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Ministry of Public Health

Bangkok, Chang Wat Nonthaburi, 11000, Thailand

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suchada Jiamsiri, MD

  Department of Disease Control, Thailand Ministry of Public Health, Bangkok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 20, 2018
• Study Start: December 17, 2018
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)