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

NCT ID: NCT04265950

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2026-07-31

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.

Detailed Description

OUTLINE: Participants living with HIV are randomized to one of three arms. HIV-negative participants are assigned to a fourth arm.

ARM 1: Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at enrollment, and at 2 and 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months.

ARM 2: 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.

ARM 3: 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.

ARM 4: 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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1 (3 doses of 9vHPV vaccine)

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.

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type: BIOLOGICAL

Given IM

Arm 2 (2 doses of 9vHPV vaccine)

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.

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type: BIOLOGICAL

Given IM

Arm 3 (1 dose of 9vHPV vaccine)

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.

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type: BIOLOGICAL

Given IM

Arm 4 (1 dose of 9vHPV vaccine)

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type: BIOLOGICAL

Given IM

Interventions

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil 9; Nonavalent HPV VLP Vaccine; Recombinant HPV Nonavalent Vaccine; Recombinant Human Papillomavirus 9-valent Vaccine

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 (<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

Exclusion Criteria

• 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asociación Civil Via Libre, Peru

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

GHESKIO Center

UNKNOWN

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Duerr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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

Rio de Janeiro, Rio de Janeiro, Brazil

GHESKIO Center

Port-au-Prince, , Haiti

Via Libre

Lima, , Peru

Countries

Brazil; Haiti; Peru

References

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.

Reference Type: DERIVED

PMID: 39871186 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

U54CA242977

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-01098

Identifier Type: REGISTRY

Identifier Source: secondary_id

10521

Identifier Type: OTHER

Identifier Source: secondary_id

RG1007065

Identifier Type: -

Identifier Source: org_study_id