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Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial

NCT04265950 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-04-29

No results posted yet for this study

Summary

This phase IV trial compares 3 different dosing schedules to find the optimal number of doses for HPV vaccination in children and adolescents living with HIV. Comparing 3 different dosing schedules may help researchers determine whether a single dose of HPV vaccine could be effective in preventing HPV in children and adolescents living with HIV.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

Sponsors & Collaborators

  • Asociación Civil Via Libre, Peru

    collaborator OTHER

  • Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ)

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • GHESKIO Center

    collaborator UNKNOWN

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ann Duerr, MD, PhD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • Brazil
  • Haiti
  • Peru

Study Locations

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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 NCT04265950 on ClinicalTrials.gov