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Completed NCT04265950

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

Conditions: HIV Infection

Sex: All
Ages: 9 Years – 13 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 97
Sponsor: Fred Hutchinson Cancer Center

Location: Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ) STD and AIDS Clinical Research Laboratory Rio de Janeiro Rio de Janeiro

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.

Eligibility Criteria

Inclusion Criteria: * ARMS 1-3: Children must be living with HIV. HIV infection documented by positive molecular test or positive serologic test. * ARM 4: Children must be healthy (e.g., without autoimmune disease or cancer) and not infected with HIV * ARMS 1-3: Children must be on a consistent, clinically appropriate combination antiretroviral therapy (ART) regimen for \> 6 months prior to study enrollment * Children must be 9-13 years-old (at or after 9th birthday, prior to 14th birthday) at enrollment. This will allow vaccination of participants within the recommended age range for receipt of HPV vaccination in Peru and Brazil. Only children ages 9-11 (at or after 9th birthday, prior to 12th birthday) will be enrolled into arms 3 and 4 * Clinical laboratory values for children in Arms 1, 2, \& 3 (CLWH) must be as described below: * CD4% \>15% or CD4 counts \>200 cells/ mm3 * VL (\ 10 mg/day of prednisone or equivalent for \> 1 week) in the 6 months prior to enrollment date * Children who received any vaccine within 3 weeks prior to enrollment date (these children will be encouraged to enroll after 3 weeks have passed) * Children who received blood-derived products within 6 months prior to enrollment or planned use during the study period * Children who weigh less than 18 kilograms * Children with cancer being treated with chemotherapy or radiation * Potential participants receiving any other investigational agents may be excluded in the opinion of the supervising physician * Children in all arms with contraindications to vaccination, including pregnancy or breastfeeding * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Children having received HPV vaccination before study entry * Children with evidence of sexually transmitted HIV infection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to HPV vaccination

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04265950). StuddyBuddy aggregates publicly available trial information.