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

Phase 4 Completed 97 enrolled Fred Hutchinson Cancer Center Asociación Civil Via Libre, Peru · collab Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ) · collab GHESKIO Center · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2022-03-10
Primary completion: 2026-05-12
Completion: 2026-06-11

Publications

Pinto-Santini D, Jalil EM, Fernandes GT, Hilaire G, Kolevic L, Cabello R, Grinsztejn B, Pape W, Deschamps MM, House MG, Brofsky E, Sahasrabuddhe VV, Dasgupta S, Pasalar S, Madeleine MM, Carter J, Prabhu PR, Galloway D, Duerr A. ULACNet-301, OPTIMO protocol: optimizing HPV vaccination regimen for cancer prevention in children and adolescents living with HIV. BMC Cancer. 2025 Jan 27;25(1):151. doi: 10.1186/s12885-025-13551-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil 9	Vaccine	—	Intramuscular

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

Summary

Timeline

Publications

Drugs

Indications