Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Hpv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220747
• Other study ID #: NRCT9-3
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Mahidol University
• Contact: Supitcha Kamolratanakul, Asst.Prof.
• Phone: 66 81 699 6660
• Email: supitcha.kam[@]mahidol.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 760
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hpv

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) = a¬i + ß e(HPV_vaccination) + ß1(cov_1) +ß2(cov_2) + ... + ßk(cov_k)where ai is the stratum-specific constant term for each matched set, ße is the parameter coefficient for the exposure of interest (receipt of HPV vaccine), and ß1 through ßk 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)