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Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents

NCT05435209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-11-29

No results posted yet for this study

Summary

The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection.

Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.

Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.

Conditions

Interventions

DRUG

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Gardasil

Sponsors & Collaborators

Principal Investigators

  • Nelly Mugo, MD · University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • Kenya

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435209 on ClinicalTrials.gov