Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265950
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : March 23, 2021
Sponsor:
Collaborators:
Asociacion Civil Via Libre
Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
HIV Infection Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Open-Label Trial in Children and Adolescents to Establish Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Experimental: 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.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Experimental: 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.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Active Comparator: 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.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine




Primary Outcome Measures :
  1. Human papillomavirus type 16 (HPV16) neutralizing antibody geometric mean titers (GMTs) (Arm 1 versus [vs.] Arm 2) [ Time Frame: At 24 months after the last dose of each vaccine regimen ]
    Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 neutralizing antibody GMT.


Secondary Outcome Measures :
  1. Human papillomavirus type 18 (HPV18) neutralizing antibody GMTs (Arm 1 vs. Arm 2) [ Time Frame: At 24 months after the last dose of each vaccine regimen ]
    Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 18 neutralizing antibody GMT.

  2. Change in HPV16 and HPV18 binding antibody median fluorescence intensity-MFI (slope) (Arm 1 vs. Arm 2) [ Time Frame: 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 ]
    The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.

  3. HPV16 and HPV18 neutralizing antibody GMTs (Arm 2 vs. Arm 3) [ Time Frame: At 24 months after the last vaccine dose ]
    Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.

  4. Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 2 vs. Arm 3) [ Time Frame: Between 1 month and 18 months after the last vaccine dose, and between 18 months and 24 months after the last vaccine dose ]
    The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.

  5. Binding antibody MFI to all 9 vaccine HPV types (Arm 2 vs. Arm 3) [ Time Frame: At month 7 in Arm 2 and month 25 in Arm 3 ]
    Compare the response to a 0, 6- months two-dose schedule vs. a 0, 24-months two-dose schedule in children living with HIV (CLWH). The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI, as well as the binding antibody MFI for other HPV types.

  6. HPV16 and HPV18 neutralizing antibody GMTs (Arm 3 vs. Arm 4) [ Time Frame: At 24 months after the first (single) vaccine dose ]
    Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.

  7. Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 3 vs. Arm 4) [ Time Frame: Between 1 month and 18 months after the single vaccine dose, and between 18 months and 24 months after the first (single) vaccine dose ]
    The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ARMS 1-3: Children must be living with HIV. HIV infection must be confirmed by local algorithm (positive nucleic acid amplification test [NAAT] test before 18 months of age and/or positive serologic test thereafter)
  • 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
  • ARMS 1-3: CD4% > 15% or CD4 counts > 200 cells/mm^3 (within 6 months prior to study entry)
  • ARMS 1-3: Viral load (VL) < 400 copies/mL (within 6 months prior to study entry)
  • 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
  • It is anticipated that all children will enter the study prior to sexual debut, although this will not be investigated clinically. 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 who are enrolled and later found to be seropositive for HPV at study entry (by Luminex assay performed by the Central Laboratory Core in Seattle) will be discontinued from the study
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to HPV vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265950


Contacts
Layout table for location contacts
Contact: Ann Duerr, MD, PhD 206-667-7938 aduerr@fredhutch.org

Locations
Layout table for location information
Brazil
Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ) STD and AIDS Clinical Research Laboratory
Rio de Janeiro, RJ, Brazil, 21040-360
Contact: Beatriz Grinsztejn    +55-21-2270-7064    gbeatriz@ipec.fiocruz.br   
Contact    +55-21-3865-9128      
Principal Investigator: Beatriz Grinsztejn         
Peru
Asociación Civil Via Libre
Lima, Peru, 15001
Contact: Robinson Cabello    (+511) 203-9900    rcabello@vialibre.org.pe   
Principal Investigator: Robinson Cabello         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Asociacion Civil Via Libre
Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ)
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Ann Duerr, MD, PhD Fred Hutch/University of Washington Cancer Consortium
Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04265950    
Other Study ID Numbers: RG1007065
U54CA242977 ( U.S. NIH Grant/Contract )
NCI-2020-01098 ( Registry Identifier: NCI / CTRP )
10521 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fred Hutchinson Cancer Research Center:
HPV vaccination
HIV infected children
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs