Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
2 other identifiers
interventional
36
1 country
6
Brief Summary
This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv
Started Aug 2023
Longer than P75 for phase_1 hiv
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
August 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 18, 2026
April 20, 2026
April 1, 2026
3.3 years
June 5, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
Local reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
2 weeks following any injection
Systemic reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
2 weeks following any injection
Number of SAEs (Serious Adverse Events) leading to early participant withdrawal or permanent discontinuation
12 months following receipt of any study product
Number of MAAEs (medically attended adverse event) leading to early participant withdrawal or permanent discontinuation
12 months following receipt of any study product
Number of AESIs (Adverse events of special interest) leading to early participant withdrawal or permanent discontinuation
12 months following receipt of any study product
Number of AEs (adverse events) leading to early participant withdrawal or permanent discontinuation
12 months following receipt of any study product
Frequency of the V3G-specific precursor IgM+ and IgG+ B cells.
Measured by flow cytometry analysis
2 weeks following injection
Secondary Outcomes (9)
Response rate of serum IgG binding Abs
2 weeks after the priming regimen and 2 weeks after the boost with V3G CH848 mRNA-Tr2
Magnitude of serum IgG binding Abs
2 weeks after the priming regimen and 2 weeks after the boost with V3G CH848 mRNA-Tr2
Response rate of serum IgG binding Abs
2 weeks after the priming regimen and 2 weeks after the boost with V3G CH848 mRNA-Tr2
Magnitude of serum IgG binding Abs
2 weeks after the priming regimen and 2 weeks after the boost with V3G CH848 mRNA-Tr2
Response rate of serum Ab autologous neutralization of vaccine-matched tier 2 HIV-1 strains
2 weeks after the priming regimen and 2 weeks after the boost with V3G CH848 mRNA-Tr2
- +4 more secondary outcomes
Study Arms (4)
Group 1: Low dose V3G CH848 Pr-NP1 with 3M-052-AF + Alum
EXPERIMENTAL3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group 2: Low dose V3G CH848 Pr-NP1 with ACU-026-001-1
EXPERIMENTAL3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group 3: V3G CH848 Pr-NP1 with 3M-052-AF + Alum
EXPERIMENTAL3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Group 4: V3G CH848 Pr-NP1 with ACU-026-001-1
EXPERIMENTAL3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit
Interventions
(50 mcg)
(2.0 mg)
(100 mcg)
(60 mcg)
(5 mcg)
(500 mcg)
Eligibility Criteria
You may qualify if:
- Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
- to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit, willing to undergo lymph node fine needle aspiration and leukapheresis, and willing to be contacted 12 months after the last study-product administration.
- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 307 PSRT are required prior to enrollment into HVTN 307.
- In good general health according to the clinical judgment of the site investigator.
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
- Assessed by clinical staff as having a low likelihood of acquiring HIV per guidelines, agrees to discuss their potential for HIV acquisition, agrees to risk-reduction counseling, and agrees to avoid behaviors associated with a higher likelihood of acquiring HIV through the final study visit. Low likelihood may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed.
- Hemoglobin (Hgb):
- ≥ 11.0 g/dL for volunteers AFAB
- ≥ 13.0 g/dL for volunteers AMAB and for volunteers AFAB or intersex at birth who have been on masculinizing hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for volunteers AMAB or intersex at birth who have been on feminizing hormone therapy for more than 6 consecutive months
- For transgender or intersex volunteers who have been on hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth
- Platelets = 125,000 to 550,000/mm3.
- Alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) based on the institutional normal range.
- Serum creatinine ≤ 1.1 x ULN based on the institutional normal range.
- +12 more criteria
You may not qualify if:
- Volunteer who is breastfeeding or pregnant.
- Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
- Previous or current recipient of an investigational HIV vaccine (previous placebo/ control recipients are not excluded).
- Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) emergency use listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use, equal to or greater than prednisone 10 mg/day within 3 months prior to enrollment.
- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
- Receipt of any of the following within 4 weeks prior to enrollment;
- Live replicating vaccines
- Any mRNA-based vaccine with FDA licensure, FDA emergency use authorization (EUA), or World Health Organization (WHO) emergency use listing
- ACAM2000 vaccine \> 28 days prior with a vaccination scab still present.
- Receipt of any vaccines that are not covered in #8 within 14 days prior to enrollment. Please note this includes replication incompetent vaccines such as the Jynneos vaccine for the prevention of mpox (formerly known as monkeypox) disease.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Idiopathic urticaria within the past year.
- Bleeding disorder diagnosed by a clinician which would make study procedures a contraindication.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Alabama CRS [Site ID: 31788]
Birmingham, Alabama, 35294-2170, United States
Emory University School of Medicine, The Ponce de Leon Center CRS [Site ID: 5802]
Atlanta, Georgia, 30303, United States
Brigham & Women's Hospital [Site ID: 30007]
Boston, Massachusetts, 02115, United States
BIDMC VCRS [Site ID: 32077]
Boston, Massachusetts, 02215, United States
Vanderbilt Vaccine (VV) CRS [Site ID: 30352]
Nashville, Tennessee, 37232-2582, United States
Seattle Vaccine and Prevention CRS [Site ID: 30331]
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
August 29, 2023
Primary Completion (Estimated)
December 18, 2026
Study Completion (Estimated)
December 18, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share