A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
2 other identifiers
interventional
57
1 country
8
Brief Summary
HVTN 144 is a phase 1 clinical trial to being conducted to evaluate the safety and immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with saponin/MPLA nanoparticles (SMNP) in adult participants without HIV. The study aims to evaluate the safety and tolerability of N332-GT5 gp140 adjuvanted with SMNP in adult volunteers without HIV and in overall good health, including identifying a safe and tolerable dose, route, and schedule of administration of the novel adjuvant SMNP. The study also aims to evaluate the induction of BG18-class immunoglobulin G (IgG) B-cell responses in memory B cells by the study regimens and compare the responses between the different groups. HVTN 144 will be conducted in 2 parts with 84 volunteers without HIV and in overall good health, aged 18 to 55 years. The study duration is 22 months which includes 8 months for enrollment, planned safety holds, follow-up, and Adverse Event of Special Interest (AESI) health contact 1 year after last vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv
Started Nov 2023
Typical duration for phase_1 hiv
8 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
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2026
CompletedMarch 27, 2026
September 1, 2025
2 years
August 18, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (10)
Local reactogenicity signs and symptoms (solicited adverse events) will be collected
Through study completion, an average of 1 year
Systemic reactogenicity signs and symptoms (solicited adverse events) will be collected
Through study completion, an average of 1 year
Number of Serious Adverse Events (SAEs) leading to early participant withdrawal or permanent discontinuation
35 weeks and for 12 months following any receipt of study product
Number of Medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation
35 weeks and for 12 months following any receipt of study product
Number of AESIs leading to early participant withdrawal or permanent discontinuation
35 weeks and for 12 months following any receipt of study product
Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation
35 weeks and for 12 months following any receipt of study product
Comparison of number of reported/assessed local and systemic reactogenicity, SAE's and AESI's and medically attended adverse events at increasing doses of adjuvant at constant dose of N332-GT5 gp140
35 weeks
Frequency of BG18 epitope-specific B cells as determined by flow cytometry
35 weeks
Proportion of participants with BG18-class IgG memory B cells in peripheral blood mononuclear cell (PBMCs), measured by antigen-specific B-cell sorting, B-cell receptor (BCR) sequencing, and bioinformatic analysis
35 weeks
Frequency of BG18-class B cells among IgG memory B cells in PBMCs, measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis
35 weeks
Secondary Outcomes (9)
Proportion of participants with BG18-class IgG B cells, measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis
35 weeks
Frequency of BG18-class B cells among IgG B cells in germinal centers (GCs), measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis
35 weeks
Response rate of serum binding Ab responses to N332-GT5 gp140 and BG18 epitope on the trimer measured by binding antibody multiplex assay (BAMA)
35 weeks
Magnitude of serum binding Ab responses to N332-GT5 gp140 and BG18 epitope on the trimer measured by binding antibody multiplex assay (BAMA)
35 weeks
Response rate of serum neutralizing antibodies (nAbs) that neutralize pseudoviruses engineered to be sensitive to BG18-precursors
35 weeks
- +4 more secondary outcomes
Study Arms (15)
Part A Intramuscular (IM) safety with dose finding - Group 1
EXPERIMENTALPart A IM safety with dose finding - Group 2
EXPERIMENTALPart A IM safety with dose finding - Group 3
EXPERIMENTALPart A IM safety with dose finding - Group 4
EXPERIMENTALPart A IM safety with dose finding - Group 5
EXPERIMENTALPart A IM safety with dose finding - Group 6
EXPERIMENTALPart A Subcutaneous (SC) safety with dose finding - Group 7
EXPERIMENTALPart A SC safety with dose finding - Group 8
EXPERIMENTALPart A SC safety with dose finding - Group 9
EXPERIMENTALPart A SC safety with dose finding - Group 10
EXPERIMENTALPart A SC safety with dose finding - Group 11
EXPERIMENTALPart A SC safety with dose finding - Group 12
EXPERIMENTALPart B IM Immunogenicity - Group 13
EXPERIMENTALPart B SC Immunogenicity - Group 14
EXPERIMENTALPart B Immunogenicity - Group 15
EXPERIMENTALGroup 15 N332-GT5 gp140 with SMNP dose and route (SC or IM) is To Be Determined (TBD) based on groups 6 and 12 (Part A).
Interventions
SC in the upper arm
SC in the upper arm, Fractionated escalating dose for prime
SC in the upper arm
SC in the upper arm, Fractionated escalating dose for prime
IM in the deltoid
IM in the deltoid, Fractionated escalating dose for prime
IM in the deltoid
IM in the deltoid, Fractionated escalating dose for prime
Eligibility Criteria
You may qualify if:
- General and demographic criteria:
- Age of 18 through 55 years
- Access to a participating HVTN Clinical Research Site (CRS) and willingness to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of Understanding (AoU): Volunteer demonstrates understanding of this study by completing a questionnaire prior to the first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent until completion of the study
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- HIV-related criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV risks and amenable to HIV risk-reduction counseling
- Assessed by the clinic staff as having a low likelihood of acquiring HIV and is committed to avoiding behaviors associated with a higher likelihood of acquiring HIV through the last required protocol clinic visit
- Hemoglobin (Hgb)
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth (AFAB)
- ≥ 13.0 g/dL for volunteers who were assigned male sex at birth (AMAB) and transgender men who have been on hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months
- +16 more criteria
You may not qualify if:
- General criteria:
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) ≥ 40, or BMI ≥ 35 with 2 or more of the following: Age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
- Intent to participate in any other study that requires non-HVTN HIV Ab testing during the planned duration of the HVTN 144 study
- Pregnant or breastfeeding
- Active duty and reserve US military personnel
- Vaccines and other injections criteria:
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 144 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis.
- Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 144 PSRT on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 144 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 144 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) more than 1 year ago, eligibility for enrollment will be determined by the HVTN 144 PSRT on a case-by-case basis.
- Live attenuated vaccines received within 30 days before the first vaccination or scheduled within 28 days after injection (eg, measles, mumps, and rubella (MMR); oral polio vaccine (OPV); varicella; yellow fever; live attenuated influenza vaccine). ACAM2000 vaccine \>28 days prior with a vaccination scab still present.
- Any vaccines that are not live attenuated vaccines and were received within 14 days prior to the first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B). Please note this includes incompetent vaccine such as the Jynneos vaccine for the prevention of mpox disease.
- Allergy treatment with antigen injections within 30 days before the first vaccination or that are scheduled within 14 days after the first vaccination
- Immune system criteria:
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Bridge HIV CRS
San Francisco, California, 94102, United States
Atlanta - Hope Clinic
Decatur, Georgia, 30030, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Columbia University Medical Center
New York, New York, 100032, United States
New York Blood Center
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Penn Prevention CRS [Site ID: 30310]
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Institute for Infection, Immunology and Inflammation
Nashville, Tennessee, 37232-2582, United States
Study Officials
- STUDY CHAIR
Lindsey Baden
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
September 13, 2023
Study Start
November 27, 2023
Primary Completion
December 10, 2025
Study Completion
March 13, 2026
Last Updated
March 27, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share