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HivPhase 1NCT05001373

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

A Phase 1 study testing Core-g28v2 60mer mRNA Vaccine and eOD-GT8 60mer mRNA Vaccine in people with Hiv, run by International AIDS Vaccine Initiative at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hiv
What is being tested?
Core-g28v2 60mer mRNA Vaccine and eOD-GT8 60mer mRNA Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesUnited States
Study dates
12 Nov 2021to 1 Jul 2024
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults as assessed by a medical history, physical examination, and laboratory tests who are at least 18 years at the time of screening and less than 51 years at the time of first IP administration;
  • 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 (informed consent) Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to IP administration and participation in the study; 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 women of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for at least 2 weeks prior to the first IP administration and continue until 4 months following the last IP administration. Effective contraception includes:
  • Condoms (male or female) with or without spermicide
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  • 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.
  • 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;
  • All participants born female who are of reproductive potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA);
  • All sexually active participants born male, regardless of reproductive potential, must be willing to use an effective method of contraception (such as consistent condom use) from the day of the first IP administration until at least 4 months after the last IP administration;
  • Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to IP-induced antibodies, until the anti-HIV antibody titers become undetectable.

Who cannot join

  • Positive test for HIV-1 or HIV-2;
  • 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, antituberculosis, 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's clinical judgment) at least 2 weeks prior to enrolment 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; Note: All chronic conditions must be considered stable, there can be no significant change of medications within the previous 2 months, and for diabetics HgbA1c must be <10%.
  • History of substance abuse or alcohol abuse;
  • Reported behavior that puts the participant at risk for HIV infection within 6 months prior to screening, 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)
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  • 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, herpes simplex virus-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 or planning a pregnancy during the period of enrolment until 4 months after the last IP administration; or lactating;
  • Bleeding disorder that was diagnosed by a physician (eg, 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 IM vaccinations 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 RNA positive), or active syphilis (screening and confirmatory tests);
  • History of splenectomy;
  • Any of the following abnormal laboratory parameters listed below at screening:
  • 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 × 109 cells/L
  • Absolute Lymphocyte Count (ALC) ≤650/mm3 or ≤0.65 × 109 cells/L
  • Platelets ≤125,000 cells/mm3 or ≤125 × 109 cells/L Chemistry
  • Creatinine ≥1.1 × upper limit of normal (ULN)
  • AST ≥1.25 × ULN
  • ALT ≥1.25 × ULN Urinalysis
  • Clinically significant abnormal dipstick confirmed by microscopy:
  • Protein = 1 + or more Blood = 2 + or more (not due to menses) or >10 RBCs per high power field. If Urinalysis is the only exclusion criteria that is met, consider repeat urinalysis to confirm
  • Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after IP administration; or receipt of other vaccine (including all authorized or approved COVID-19 vaccinations) within the previous 14 days or planned receipt within 14 days after IP administration. (Exception is live attenuated influenza vaccine within 14 days); Note 1: COVID-19 vaccinations: Participants should not have received any COVID-19 vaccinations in the 14 days before or 14 days after IP administration.
  • Note 2: COVID-19 immunoprophylaxis will be permitted prior to and/or during the study provided the agent has received either Emergency Use Approval from FDA, Conditional Marketing Authorization from EMA, or granted licensure from a country's regulatory agency.
  • Receipt of blood transfusion or blood-derived products within the previous 3 months;
  • Participation in another clinical study of an IP currently, within the previous 3 months or expected participation during this study; Note: Concurrent participation in an observational study not requiring blood or tissue sample collection is not an exclusion;
  • Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody; Note: Receipt of placebo in a previous monoclonal antibody including HIV monoclonal antibody study will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.
  • History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis, or ulceration); (This includes individuals with history of anaphylaxis and/or severe hypersensitivity reaction to mRNA vaccines or its excipients)
  • Psychiatric condition that compromises the 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 that is considered cured is not an exclusion);
  • Active, serious infections as assessed by the Investigator requiring antibiotic, antiviral or antifungal therapy within 30 days prior to enrolment;
  • 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 applicable at the study site);
  • If, in the opinion of the PI, it is not in the best interest of the participant to participate in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University

    Atlanta, Georgia, 30322

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • George Washington University

    Washington D.C., District of Columbia, 20052

Other trials in United States

About this study

Official title: A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

Read the detailed description

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health. The hypothesis is that sequential vaccination by a germline-targeting prime followed by directional boost immunogens can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development through an mRNA platform. Fifty-six participants. Adults 18 to 50 years of age who meet all protocol inclusion criteria, who do not meet any protocol exclusion criteria, who understand the study (as demonstrated by the Assessment of [Informed Consent] Understanding [AOU]), and who can provide written informed consent. Randomization allocation is 16:16:16:8 for Groups 1-4 respectively.

There is no blinding in this study. Site and study staff will not be blinded to the IP.

Conditions
Hiv
Being tested
Core-g28v2 60mer mRNA Vaccine, eOD-GT8 60mer mRNA Vaccine
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.

  • Core-g28v2 60mer mRNA VaccineBiological

    100µg, Intramuscularly

  • eOD-GT8 60mer mRNA VaccineBiological

    100µg, Intramuscularly

Study groups in NCT05001373
Study groupRoleWhat they receive
Study Group 1ExperimentaleOD-GT8 60mer mRNA Vaccine (100µg)
Receives: Biological: eOD-GT8 60mer mRNA Vaccine
Study Group 2ExperimentaleOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
Receives: Biological: Core-g28v2 60mer mRNA Vaccine; Biological: eOD-GT8 60mer mRNA Vaccine
Study Group 3ExperimentaleOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
Receives: Biological: Core-g28v2 60mer mRNA Vaccine; Biological: eOD-GT8 60mer mRNA Vaccine
Study Group 4ExperimentalCore-g28v2 60mer mRNA Vaccine (100µg)
Receives: Biological: Core-g28v2 60mer mRNA Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    • Proportion of participants with local and systemic solicited Adverse Events (AEs) from Day 1 to Day 7 inclusive after each IP administration
    • Proportion of participants with Grade 2 or higher unsolicited Adverse Events (AEs), including safety laboratory (biochemical, hematological) parameters from the day of each IP administration through 28 days after each IP administration (any event AND any possibly, probably, or definitely related event)
    • Proportion of participants with Serious Adverse Events (SAEs) throughout the study period (any event AND any possibly, probably, or definitely related event)
    • Proportion of participants with Medical Attended Adverse Events (MAAEs) from the first day of IP administration through 24 weeks post final IP administration

    Measured: 9 months

Secondary outcomes (1)

  1. Immunogenicity

    • Proportion of participants with VRC01-class IgG B-cells
    • Frequency of VRC01-class B-cells among IgG B-cells in PBMCs or in germinal centers, after each IP administration and at baseline
    • Proportion of participants with serum binding antibody responses to eOD-GT8 60mer, eOD-GT8 monomer, Core-g28v2 60mer, Core-g28v2 monomer, the CD4bs epitope on eOD-GT8, and the CD4bs epitope on Core-g28v2 after each IP administration and at baseline
    • Magnitude of responses to eOD-GT8 60mer, eOD-GT8 monomer, Core-g28v2 60mer, Core-g28v2 monomer, the CD4bs epitope on eOD-GT8, and the CD4bs epitope on Core-g28v2 after each IP administration and at baseline

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start12 Nov 2021
  3. Primary completion20 Jun 2023
  4. Study completion1 Jul 2024 (estimated)

Resources

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001373
Sponsor's protocol ID
IAVI G002
Status last verified
Apr 2024
First submitted
1 Jul 2021
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: To be Determined

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Core-g28v2 60mer mRNA Vaccine and eOD-GT8 60mer mRNA Vaccine in people with Hiv, run by International AIDS Vaccine Initiative at 4 sites in United States.

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 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 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?

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?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 9 months). 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 NCT05001373.

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 1 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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