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

NCT04265950 | Active Not Recruiting Phase 4 DMC FDA Drug

• 4 other identifiers: RG1007065U54CA242977NCI-2020-0109810521
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

HPV vaccination; HIV infected children

Outcome Measures

Primary Outcomes (1)

• Human papillomavirus type 16 (HPV16) neutralizing antibody geometric mean titers (GMTs) (Arm 1 versus [vs.] Arm 2)

  Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 neutralizing antibody GMT.

  At 24 months after the last dose of each vaccine regimen

Secondary Outcomes (7)

• Human papillomavirus type 18 (HPV18) neutralizing antibody GMTs (Arm 1 vs. Arm 2)

  At 24 months after the last dose of each vaccine regimen

• Change in HPV16 and HPV18 binding antibody median fluorescence intensity-MFI (slope) (Arm 1 vs. Arm 2)

  Between 1 month after the last dose and 18 months after the last dose, and between 18 months and 24 months after the last dose of each vaccine regimen

• HPV16 and HPV18 neutralizing antibody GMTs (Arm 2 vs. Arm 3)

  At 24 months after the last vaccine dose

• Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 2 vs. Arm 3)

  Between 1 month and 18 months after the last vaccine dose, and between 18 months and 24 months after the last vaccine dose

• Binding antibody MFI to all 9 vaccine HPV types (Arm 2 vs. Arm 3)

  At month 7 in Arm 2 and month 25 in Arm 3

Study Arms (4)

Arm 1 (3 doses of 9vHPV vaccine)

EXPERIMENTAL

Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment, and at 2 and 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months.

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm 2 (2 doses of 9vHPV vaccine)

EXPERIMENTAL

Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment and at 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months.

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm 3 (1 dose of 9vHPV vaccine)

EXPERIMENTAL

Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months.

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm 4 (1 dose of 9vHPV vaccine)

ACTIVE COMPARATOR

Participants without HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment . Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months.

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Interventions

Recombinant Human Papillomavirus Nonavalent Vaccine BIOLOGICAL

Given IM

Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Arm 1 (3 doses of 9vHPV vaccine); Arm 2 (2 doses of 9vHPV vaccine); Arm 3 (1 dose of 9vHPV vaccine); Arm 4 (1 dose of 9vHPV vaccine)

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 (\<400 copies/mL)
• All female participants must not be pregnant (all females will receive pregnancy tests at all vaccine visits prior to receipt of study vaccine). The effects of Gardasil 9 on the developing human fetus at the recommended therapeutic dose are unknown. If pregnancy is confirmed during the screening process, enrollment will not occur. If pregnancy occurs after the first vaccine dose, additional vaccine doses will not be administered, but the child will remain in study follow-up.
• We anticipate that all children will enter the study prior to sexual debut. Sexual debut will be ascertained by participant questioning in Haiti. Physical examination will not be performed at any of the study sites. Potential participants who report sexual activity will not be enrolled
• Children in all arms must have the ability to understand and the willingness to assent to the study. Parents or guardians must be able to understand and willing to sign a written informed consent document

You may not qualify if:

• Children who have a serious illness requiring treatment with systemic medications other than ART (excluding short course oral steroids or inhaled steroid treatment for asthma), are currently under immunomodulatory therapy, received immunosuppressive therapy (\> 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Asociación Civil Via Libre, Peru: collaborator
• Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ): collaborator
• National Cancer Institute (NCI): collaborator
• GHESKIO Center: collaborator

Study Sites (3)

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

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

GHESKIO Center

Port-au-Prince, Haiti

Location

Via Libre

Lima, 15001, Peru

Location

Related Publications (1)

• 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.

  PMID: 39871186 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ann Duerr, MD, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: March 10, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1); HA (1); BR (1)