A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV

Completed · Phase 1

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT06033209

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

57

Starts

2023-11-27

Expected to finish

2026-03-13

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• Laboratory inclusion values Criteria:
• 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
• For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth
• White blood cell (WBC) count = 2500 to 12000 cells/mm3 with normal differential, or differential approved by Investigator of Record (IoR) as not clinically significant
• Total lymphocyte count ≥ 650 cells/mm3 with normal differential, or differential approved by IoR as not clinically significant
• Remaining differential either within local lab reference range or with site physician approval
• Platelets = 125000 to 550000 cells/mm3
• Chemistry panel: Alanine aminotransferase (ALT) < 1.25 times the institutional upper limit of normal (ULN); serum creatinine ≤ 1.1 x ULN based on the local lab reference range.
• Corrected total serum calcium level of ≥ 8.5 mg/dL
• Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA)
• Negative Hepatitis B surface antigen (HBsAg)

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:
• Immunosuppressive medications received within 168 days before first vaccination (not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment)
• Serious adverse reactions to vaccines or to vaccine components such as AS01B ("Shingrix") or Matrix M (Novovax CoV2373), including history of anaphylaxis and related symptoms, such as hives, respiratory difficulty, angioedema, and/or abdominal pain (not exclusionary: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child).
• IgG received within 60 days before first vaccination (for mAbs, see criterion #8 above)
• Autoimmune disease, current or history (not exclusionary: mild, well-controlled psoriasis)
• AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) administered in this protocol.
• Immunodeficiency
• Clinically significant medical conditions criteria:
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response,
• A process that would require medication that affects the immune response,

Where it is running

• Bridge HIV CRS — San Francisco, California, United States
• Atlanta - Hope Clinic — Decatur, Georgia, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• New York Blood Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Penn Prevention CRS [Site ID: 30310] — Philadelphia, Pennsylvania, United States
• Vanderbilt Institute for Infection, Immunology and Inflammation — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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