Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa

NCT06449196 | Withdrawn Early Phase 1 DMC

• 1 other identifier: IAVI C112
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV

Keywords

People Living with HIV (PLWH)

Outcome Measures

Primary Outcomes (1)

• 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.

  15 months

Secondary Outcomes (1)

• Immunogenicity

  15 months

Other Outcomes (1)

• Exploratory

  15 months

Study Arms (2)

Bolus Dosing

EXPERIMENTAL

HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing

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

Drug: : Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)

Interventions

: 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

Fractionated Dosing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Polymun Scientific GmbH: collaborator

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 7, 2024
• Study Start: August 27, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Information will be shared as soon as results are publicly available for the investigational product being used in similar studies conducted in other regions. The existing results and data upon which the C112 study is based is yet to be made fully publicly available.
• Access Criteria: Access to data will be determined by the study team, partners and funding agencies.