Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

NCT06220747 | Recruiting

• 1 other identifier: NRCT9-3
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.

Conditions

Hpv

Outcome Measures

Primary Outcomes (1)

• The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45

  Estimation of overall vaccine effectiveness For the planned analyses, the log odds of disease for individuals in matched sets will be modelled using the following conditional logistic model:Model 1 : Log (oddcase) = α¬i + β e(HPV\_vaccination) + β1(cov\_1) +β2(cov\_2) + ... + βk(cov\_k)where αi is the stratum-specific constant term for each matched set, βe is the parameter coefficient for the exposure of interest (receipt of HPV vaccine), and β1 through βk are the parameter coefficients for each covariate included in the model to control for confounding. Our modelling strategy will be to create models that always contain the exposure variable of interest (receipt of HPV vaccine) and additional covariates as needed.

  1 visit (1 day)

Study Arms (1)

women aged 12-45 years old

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Target populations are any women aged 12-45-year-old who interest this project. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will selection based on their outcome, not based on exposure. Cases were women who met the inclusion criteria and tested positive for HPV DNA (self-cervical swab/ urine sample: positive), and controls were defined as women who met inclusion criteria but HPV DNA tested negative.

You may qualify if:

• Women aged 12-45 who willing to do HPV test check-up.
• Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
• Based on clinical judgment, the participant with underlying chronic disease who has stable and well-controlled medical conditions.

You may not qualify if:

• Participant with history of total hysterectomy and loop electrosurgical excision procedure.
• Participant who received 3 doses HPV vaccine.
• Any condition that might confound the interpretation of vaccine effectiveness by investigator

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (2)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, Select..., 10400, Thailand

RECRUITING

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,

Bangkok, 10400, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine collection 10-30 ml. and self cervical swab

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

• Punnee Pitisuttithum, Prof.

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  STUDY CHAIR

Central Study Contacts

Supitcha Kamolratanakul, Asst.Prof.

CONTACT

66 81 699 6660; supitcha.kam@mahidol.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: March 29, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

TH (2)