HivPhase 1NCT05863585
A Clinical Trial to Evaluate the Safety and Immunogenicity of a Prophylactic HIV Vaccine Candidate
A Phase 1 study testing BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) in people with Hiv, run by International AIDS Vaccine Initiative.
Trial summary
An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted Read more about this study
- Who is it for?
- Ages 18 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Mar 2025
- Phase
- Phase 1
- 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 18 to 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults as assessed by a medical history, physical exam, and laboratory tests
- Received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- Willing to comply with the requirements of the protocol and be available for follow-up for the planned duration of the study
- In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to vaccine administration and participation in the trial; written informed consent will be obtained from the participant before any study-related procedures are performed
- Willing to undergo HIV testing, risk reduction counseling and receive HIV-test results
- All participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception starting 2 weeks before the first vaccine administration and for 4 months following the last vaccine administration. Effective contraception includes:
Show all 15Show fewer
- Condoms (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device
- Hormonal contraception, including contraceptive implant or injectable
- Oral contraception
- Successful vasectomy in the male partner
- Considered successful if a woman reports that a male partner has:
- documentation of azoospermia by microscopy (1 year ago) or
- a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy • Not of reproductive potential Such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation, postmenopausal (≥45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/L), surgically sterile Note: More restrictive measures may be required by the study sites. 7. All participants born female who are not heterosexually active at screening must agree to utilize an effective method of contraception if they become heterosexually active as outlined above 8. All participants born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Assessments (SOA) (Appendix A) 9. Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to vaccine-induced antibodies, until the anti-HIV-antibody titers become undetectable
Who cannot join
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the Investigator within the previous 6 months.
- Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
- Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
- Reported behavior that put the participant at risk for HIV infection within 6 months prior to vaccine administration, as defined by:
- Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection or a casual partner (ie, no continuing established relationship)
Show all 39Show fewer
- Engaged in sex work
- Frequent excessive daily alcohol use or frequent binge drinking, or any other use of illicit drugs
- History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or hepatitis C
- Three or more sexual partners
- If female, pregnant, lactating, or planning a pregnancy during the period of enrollment until 4 months after the last vaccine administration
- Bleeding disorder that was diagnosed by a physician (eg, clotting factor deficiency, coagulopathy or platelet disorder that requires special precautions) Note: A participant who states that he/she has easy bruising or bleeding, but does not have a formal diagnosis and has IM injections and blood draws without any adverse experience is eligible
- Infectious disease diagnosis: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV ribonucleic acid (RNA) positive or interferon-alfa treatment for hepatitis C infection in the past year or interferon-alfa-free treatment for hepatitis C infection completed in the past 6 months), or active syphilis (screening and confirmatory tests)
- History of splenectomy
- Any of the following abnormal laboratory parameters listed below:
- Hematology
- Hemoglobin - <10.5 g/dl or <6.5 mmol/L in females; <11.0 g/dl or <6.8 mmol/L in males
- Absolute Neutrophil Count (ANC) - ≤1,000/mm3 or < 1.0 x 109 cells/L
- Absolute Lymphocyte Count (ALC) - ≤650/mm3 or < 0.65 x 109 cells/L
- Platelets - <125,000 cells/mm3 or <125 x 109 cells/L Chemistry
- Creatinine - >1.1 x upper limit of normal (ULN)
- AST - >1.25 x ULN
- ALT - >1.25 x ULN Urinalysis
- Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 1+ or more
- Blood = 2+ or more (not due to menses)
- Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccine administration; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccine administration. (Exception is live attenuated influenza vaccine within 14 days.)
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Participation in another clinical trial of a vaccine currently, within the previous 3 months or expected participation during this study (with the exception of Protocol IAVI C101); concurrent participation in an observational trial not requiring blood or tissue sample collection is not an exclusion
- Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody other than BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration)
- Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
- Seizure disorder: A participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years)
- History of malignancy in the past 5 years (prior to screening) or ongoing malignancy (a history of completely excised malignancy, which is considered cured, is not an exclusion)
- Active, serious infections requiring antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment
- Body mass index (BMI) ≥35
- Body weight <110 pounds (50 kg)
- Prior daily use of NSAID/aspirin that cannot be held for 5 days prior to the leukapheresis procedure (if required by the study site)
- If, in the opinion of the PI, it is not in the best interest of the participant to participate in the trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults in Good General Health Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
Read the detailed description
This is an open-label study to evaluate the safety and immunogenicity of 2 doses of 100µg of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to HIV-1 uninfected adults in good general health who have received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, as part of Protocol IAVI C101 (NCT04224701).
Up to 14 participants, who had enrolled in and completed the phase 1 Protocol IAVI C101 "A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults (NCT04224701) and who received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, will be recruited into the study. Protocol IAVI C101 evaluated the capacity of GT1.1 to prime desirable on-target responses against the CD4 binding site (CD4bs) of the HIV virion, including but not limited to VRC01 class responses, as well as against V2-apex.
This study, Protocol IAVI C107, will examine if maturation of anti-HIV antibody response occurs following boost immunizations with BG505 SOSIP.664 gp140 Vaccine, Adjuvanted. It is expected that this study will provide insight into if and how BG505 SOSIP.664 immunization can expand and mature desirable on-target CD4bs and V1V2-apex responses.
- Conditions
- Hiv
- Being tested
- BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)Drug
100µg
| Study group | Role | What they receive |
|---|---|---|
| BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) | Experimental | BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage Receives: Drug: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Proportion of participants with Grade 2 or greater reactogenicity (ie, solicited AEs) from Day 0 through Day 7 after each vaccine administration
Measured: 7 days
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Proportion of participants with vaccine-related unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration
Measured: 28 days
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Proportion of participants with Grade 2 or greater unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration
Measured: 28 days
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Proportion of participants with vaccine-related SAEs throughout the study period
Measured: 1 year
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Proportion of participants in each group with potential immune-mediated diseases (pIMDs) from the day of first vaccine administration throughout the study period
Measured: 1 year
Secondary outcomes (1)
To determine the immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Frequency and magnitude of binding antibody responses to 2 doses of 100µg of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to adults in good general health who have received 3 doses of 300ug of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study startJun 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Access to Advanced Health Institute (AAHI), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863585
- Sponsor's protocol ID
- IAVI C107
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults in Good General Health Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- ClinicalTrials.gov ID
- NCT05863585
- Acronym / sponsor ID
- IAVI C107
- Conditions
- Hiv
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Access to Advanced Health Institute (AAHI), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 May 2023 (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.
An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
Detailed description
This is an open-label study to evaluate the safety and immunogenicity of 2 doses of 100µg of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to HIV-1 uninfected adults in good general health who have received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, as part of Protocol IAVI C101 (NCT04224701).
Up to 14 participants, who had enrolled in and completed the phase 1 Protocol IAVI C101 "A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults (NCT04224701) and who received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, will be recruited into the study. Protocol IAVI C101 evaluated the capacity of GT1.1 to prime desirable on-target responses against the CD4 binding site (CD4bs) of the HIV virion, including but not limited to VRC01 class responses, as well as against V2-apex.
This study, Protocol IAVI C107, will examine if maturation of anti-HIV antibody response occurs following boost immunizations with BG505 SOSIP.664 gp140 Vaccine, Adjuvanted. It is expected that this study will provide insight into if and how BG505 SOSIP.664 immunization can expand and mature desirable on-target CD4bs and V1V2-apex responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) | Experimental | Drug: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy adults as assessed by a medical history, physical exam, and laboratory tests
- Received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- Willing to comply with the requirements of the protocol and be available for follow-up for the planned duration of the study
- In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to vaccine administration and participation in the trial; written informed consent will be obtained from the participant before any study-related procedures are performed
- Willing to undergo HIV testing, risk reduction counseling and receive HIV-test results
Key exclusion criteria (39 listed)
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the Investigator within the previous 6 months.
- Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
- Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
- Reported behavior that put the participant at risk for HIV infection within 6 months prior to vaccine administration, as defined by:
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 |
|---|---|---|
| BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)100µg | Drug | BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) |
Primary outcome
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 7 days
Proportion of participants with Grade 2 or greater reactogenicity (ie, solicited AEs) from Day 0 through Day 7 after each vaccine administration
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 28 days
Proportion of participants with vaccine-related unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 28 days
Proportion of participants with Grade 2 or greater unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 1 year
Proportion of participants with vaccine-related SAEs throughout the study period
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 1 year
Proportion of participants in each group with potential immune-mediated diseases (pIMDs) from the day of first vaccine administration throughout the study period
1 secondary outcome
To determine the immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) in people with Hiv, run by International AIDS Vaccine Initiative.
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 15 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dagna Laufer, MD (212-328-7459, dlaufer@iavi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2023.