Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

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.

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Key information

Conditions

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

Age range

12 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Select..., Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 1 visit (1 day)

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Supitcha Kamolratanakul, Asst.Prof.

CONTACT

[email protected]

66 81 699 6660

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

National Research Council of Thailand

Registry information

Official study title

Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 24, 2024
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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