HIV InfectionPhase 4OPTIMONCT04265950
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial
A Phase 4 study testing Recombinant Human Papillomavirus Nonavalent Vaccine in people with HIV Infection, run by Fred Hutchinson Cancer Center at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Recombinant Human Papillomavirus Nonavalent Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Mar 2022to 11 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
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
About this study
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
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.
Read the 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
- Being tested
- Recombinant Human Papillomavirus Nonavalent Vaccine
- Keywords
- HPV vaccination, HIV infected children
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Papillomavirus Nonavalent VaccineBiological
Also called Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine
Given IM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Recombinant Human Papillomavirus Nonavalent Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 18 neutralizing antibody GMT.
Measured: 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)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Measured: 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)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.
Measured: At 24 months after the last vaccine dose
Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 2 vs. Arm 3)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Measured: 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)
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.
Measured: At month 7 in Arm 2 and month 25 in Arm 3
HPV16 and HPV18 neutralizing antibody GMTs (Arm 3 vs. Arm 4)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.
Measured: At 24 months after the first (single) vaccine dose
Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 3 vs. Arm 4)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Measured: Between 1 month and 18 months after the single vaccine dose, and between 18 months and 24 months after the first (single) vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start10 Mar 2022
- Primary completion12 May 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Civil Via Libre, Peru, Oswaldo Cruz Foundation, National Cancer Institute (NCI), GHESKIO Center
- Responsible party
- Sponsor
- Investigators
- Ann Duerr, MD, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265950
- Sponsor's protocol ID
- RG1007065
- Other IDs
- U54CA242977, NCI-2020-01098, 10521
- Acronym
- OPTIMO
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39871186
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04265950
- Acronym / sponsor ID
- OPTIMO / RG1007065
- Conditions
- HIV Infection
- Keywords
- HPV vaccination, HIV infected children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Asociación Civil Via Libre, Peru, Oswaldo Cruz Foundation, National Cancer Institute (NCI), GHESKIO Center
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (3 doses of 9vHPV vaccine) | Experimental | Biological: Recombinant Human Papillomavirus Nonavalent VaccineParticipants 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. |
| Arm 2 (2 doses of 9vHPV vaccine) | Experimental | Biological: Recombinant Human Papillomavirus Nonavalent VaccineParticipants 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 (1 dose of 9vHPV vaccine) | Experimental | Biological: Recombinant Human Papillomavirus Nonavalent VaccineParticipants 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 (1 dose of 9vHPV vaccine) | Active comparator | Biological: Recombinant Human Papillomavirus Nonavalent VaccineParticipants 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Papillomavirus Nonavalent VaccineAlso: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent VaccineGiven IM | Biological | 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) |
Primary outcome
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.
7 secondary outcomes
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
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
HPV16 and HPV18 neutralizing antibody GMTs (Arm 2 vs. Arm 3)
Time frame: At 24 months after the last vaccine dose
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
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
HPV16 and HPV18 neutralizing antibody GMTs (Arm 3 vs. Arm 4)
Time frame: At 24 months after the first (single) vaccine dose
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 39871186Pinto-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Duerr, MD, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Papillomavirus Nonavalent Vaccine in people with HIV Infection, run by Fred Hutchinson Cancer Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Haiti, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.