HIVEarly Phase 1C112NCT06449196
Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa
A Early Phase 1 study testing Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) and : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) in people with HIV, run by International AIDS Vaccine Initiative.
Trial summary
An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa, Randomized for Assessment of Fractional Doses. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV
- What is being tested?
- Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) and : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2024to 4 Feb 2025
- Phase
- Early 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed HIV-1 infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing;
- CD4 ≥ 300 cells/µl;
- Currently on ART, and documentation of continuous combination ART (cART) treatment with suppression of plasma HIV-1 viral load < 50 copies / ml for greater than 6 months, measured on at least 2 independent occasions, and with a viral load < 50 copies / ml at time of screening (within 42 days prior to IP administration). cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.
- Having serum neutralization breadth of at least 20% using a 12-virus global panel at screening.
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
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- In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
- All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception for 4 months following IP administration, including:
- Condoms (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device, or contraceptive implant
- Hormonal contraception
- Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy (< 1 year ago), or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy)
- Not be 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: no additional contraception required.
- Women, who are not sexually active at screening, must agree to utilize an effective method of contraception if they become sexually active, as outlined above. Note: The Sponsor considers the above methods of contraception to be effective. More restrictive measures may be required by the site.
- All female participants must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to IP administration.
Who cannot join
- Any clinically significant acute or chronic medical condition, other than HIV infection, that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.
- History of AIDS-defining illness or CD4 < 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.
- Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
- History of a splenectomy.
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- Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after administration of IP; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days of administration of the IP (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 an investigational product currently, within the previous 3 months or expected participation during this study.
- Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody, or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.
- History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema);
- 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.
- If, in the opinion of the Principal Investigator, it is not in the best interest of the participant to participate in the trial.
- 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.)
- Infectious disease: chronic hepatitis B infection (HbsAg), current hepatitis C infection (HCV Ab positive and HCV RNA positive) or treatment for hepatitis C infection in the past year, or active syphilis (RPR confirmed by TPHA).
- A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy;
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrolment.
- Any of the following abnormal laboratory parameters listed below:
- Haematology
- Haemoglobin <10.5 g/dL in females; haemoglobin <11.0 g/dL in males
- Absolute Neutrophil Count (ANC): ≤1000/mm3
- Absolute Lymphocyte Count (ALC): < 650/mm3
- Platelets: < 125,000 mm3 or ≥ 550,000/mm3 Chemistry
- Sodium ≤135 mEq/L or ≥ 146 mEq/L
- Potassium ≤3.4 mEq/L or ≥ 5.6 mEq/L
- Creatinine ≥1.1 x ULN
- AST ≥1.25 x ULN
- ALT ≥1.25 x ULN
- Total bilirubin ≥1.25 x ULN
- Alkaline phosphatase ≥1.25 x ULN
- Albumin ≤ 3.0 g/dL or ≤ 30 g/L Urinalysis
- Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 1+ or more
- Blood = 1+ or more (not due to menses)
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, other than HIV; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.
- 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 6 weeks prior to enrolment in this study.
About this study
Official title: An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV PLWH) in Africa, Randomized for Assessment of Fractional Doses
An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa, Randomized for Assessment of Fractional Doses.
Read the detailed description
The study will enroll people living with HIV, 18-50 years of age on a stable antiretroviral therapy regimen; principal exclusion criteria include history of AIDS-defining illness, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities.
- Conditions
- HIV
- Being tested
- Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM), : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)
- Keywords
- People Living with HIV (PLWH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)Drug
HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing.
: Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)Drug
HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via fractionated dosing
| Study group | Role | What they receive |
|---|---|---|
| Bolus Dosing | Experimental | HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing Receives: Drug: Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) |
| Fractionated Dosing | Experimental | HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via fractionated dosing Receives: Drug: : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate incidence of reactogenicity events, adverse events and serious adverse events (Safety and Tolerability).
Proportion of volunteers with moderate or greater reactogenicity events from initial administration through 7 days following completion of each dose of the investigational product.
Proportion of volunteers with moderate or greater vaccine-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from initial administration through 28 days following completion of each dose of the investigational product.
Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period.
Measured: 15 months
Secondary outcomes (1)
Immunogenicity
Proportion of volunteers with improvement in neutralizing activity, based on breadth and potency, prior to and after immunization with the Env Mosaic immunogens.
Difference in neutralization breadth and potency with fractionated dosing compared to bolus doses of the Env Mosaic immunogens.
Proportion, magnitude, and epitope-specificity of serum IgG binding responses to the Mosaic Env trimers after immunization with the Env Mosaic immunogens compared to baseline.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start27 Aug 2024
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Why it stopped: Funding withdrawn
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Polymun Scientific GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449196
- Sponsor's protocol ID
- IAVI C112
- Acronym
- C112
- Status last verified
- Feb 2025
- First submitted
- 14 May 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will be done with the clinical trial team, collaborators and funding agencies. Also, as information becomes available, this will be shared with the site and study participants. Results dissemination plans will be developed and implemented as the study progresses.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV PLWH) in Africa, Randomized for Assessment of Fractional Doses
- ClinicalTrials.gov ID
- NCT06449196
- Acronym / sponsor ID
- C112 / IAVI C112
- Conditions
- HIV
- Keywords
- People Living with HIV (PLWH)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Polymun Scientific GmbH
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 7 Jun 2024 (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 Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa, Randomized for Assessment of Fractional Doses.
Detailed description
The study will enroll people living with HIV, 18-50 years of age on a stable antiretroviral therapy regimen; principal exclusion criteria include history of AIDS-defining illness, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus Dosing | Experimental | Drug: Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing |
| Fractionated Dosing | Experimental | Drug: : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via fractionated dosing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Confirmed HIV-1 infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing;
- CD4 ≥ 300 cells/µl;
- Currently on ART, and documentation of continuous combination ART (cART) treatment with suppression of plasma HIV-1 viral load < 50 copies / ml for greater than 6 months, measured on at least 2 independent occasions, and with a viral load < 50 copies / ml at time of screening (within 42 days prior to IP administration). cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.
- Having serum neutralization breadth of at least 20% using a 12-virus global panel at screening.
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
Key exclusion criteria (37 listed)
- Any clinically significant acute or chronic medical condition, other than HIV infection, that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.
- History of AIDS-defining illness or CD4 < 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.
- Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
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 |
|---|---|---|
| Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing. | Drug | Bolus Dosing |
| : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via fractionated dosing | Drug | Fractionated Dosing |
Primary outcome
To evaluate incidence of reactogenicity events, adverse events and serious adverse events (Safety and Tolerability).
Time frame: 15 months
Proportion of volunteers with moderate or greater reactogenicity events from initial administration through 7 days following completion of each dose of the investigational product. Proportion of volunteers with moderate or greater vaccine-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from initial administration through 28 days following completion of each dose of the investigational product. Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period.
1 secondary outcome
Immunogenicity
Time frame: 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Yes. This will be done with the clinical trial team, collaborators and funding agencies. Also, as information becomes available, this will be shared with the site and study participants. Results dissemination plans will be developed and implemented as the study progresses.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) and : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) 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 16 inclusion and 37 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: withdrawn, as of the sponsor's last update on 14 Mar 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate incidence of reactogenicity events, adverse events and serious adverse events (Safety and Tolerability). (time frame: 15 months). 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 14 Mar 2025.