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A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

2026. szeptember 11. frissítette: National Institute of Allergy and Infectious Diseases (NIAID)

A Nonrandomized Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

42

Fázis

  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Argentína
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentína, C1427CEA
        • Még nincs toborzás
        • Fundacion Huesped CRS (Site ID: 31957)
        • Kapcsolatba lépni:
  • Egyesült Államok
    • Alabama
      • Birmingham, Alabama, Egyesült Államok, 35222
        • Toborzás
        • Alabama CRS (Site ID: 31788)
        • Kapcsolatba lépni:
    • Georgia
      • Atlanta, Georgia, Egyesült Államok, 30308
        • Toborzás
        • The Ponce de Leon Center CRS (Site ID: 5802)
        • Kapcsolatba lépni:
      • Decatur, Georgia, Egyesült Államok, 30030
        • Még nincs toborzás
        • The Hope Clinic of the Emory Vaccine Center CRS (Site #: 31440)
        • Kapcsolatba lépni:
    • Massachusetts
      • Boston, Massachusetts, Egyesült Államok, 02115
        • Toborzás
        • Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)
        • Kapcsolatba lépni:
    • New York
      • New York, New York, Egyesült Államok, 10032
        • Még nincs toborzás
        • Columbia P&S CRS (Site#: 30329)
        • Kapcsolatba lépni:
      • Rochester, New York, Egyesült Államok, 14642
        • Még nincs toborzás
        • University of Rochester Vaccines to Prevent HIV Infection CRS (Site#: 31467)
        • Kapcsolatba lépni:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Egyesült Államok, 19104
        • Még nincs toborzás
        • Penn Prevention CRS (Site#: 30310)
        • Kapcsolatba lépni:
    • Texas
      • Houston, Texas, Egyesült Államok, 77030-1501
        • Még nincs toborzás
        • Houston Advancing Research Team CRS (Site # 31473)
        • Kapcsolatba lépni:
    • Washington
      • Seattle, Washington, Egyesült Államok, 98109
        • Toborzás
        • Seattle Vaccine and Prevention CRS (Site ID: 30331)
        • Kapcsolatba lépni:
  • Peru
    • Lima Province
      • Lima, Lima Province, Peru, 15001
        • Még nincs toborzás
        • Via Libre CRS (Site ID: 31909)
        • Kapcsolatba lépni:
      • Lima, Lima Province, Peru, 15063
        • Még nincs toborzás
        • Barranco CRS (Site ID: 11301)
        • Kapcsolatba lépni:
          • Consuelo T. Ramirez
          • Telefonszám: 210 51-1-2067800
      • Lima, Lima Province, Peru, 15088
        • Még nincs toborzás
        • San Miguel CRS (Site ID: 11302)
        • Kapcsolatba lépni:
    • Provincia Constitucional del Callao
      • Bellavista, Provincia Constitucional del Callao, Peru, 07006
        • Még nincs toborzás
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
        • Kapcsolatba lépni:
          • Fanny G. Rosas Benancio
          • Telefonszám: 1007 51-1-4800401
          • E-mail: frosas@citbm.pe
  • Zimbabwe
      • Harare, Zimbabwe
        • Még nincs toborzás
        • Seke South CRS/30294 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)
        • Kapcsolatba lépni:
      • Harare, Zimbabwe
        • Még nincs toborzás
        • Spilhaus CRS/30314 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

Inclusion Criteria:

  • Able and willing to provide informed consent.
  • Age 18 to 60 years.
  • Documented HIV infection.
  • Lowest (nadir) CD4+ count between 250 and 450 cells/mm³.
  • On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening.
  • Plasma HIV RNA <50 copies/mL for at least 48 weeks prior to enrollment, allowing limited transient increases.
  • CD4+ count >450 cells/mm³ and CD4+ percentage ≥15%.
  • Willing and able to comply with study visits and procedures.
  • Agrees not to participate in another investigational study during participation unless approved.
  • In general good health, with no clinically significant findings on physical exam or laboratory testing.
  • Hemoglobin ≥11.0 g/dL (women) or ≥13.0 g/dL (men).
  • Absolute neutrophil count ≥750/mm³.
  • Platelet count ≥100,000/mm³.
  • ALT <2.5 × upper limit of normal.
  • Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m².
  • Serum creatinine ≤1.1 × upper limit of normal.
  • Serum calcium >8.5 mg/dL.
  • Blood pressure within acceptable limits.
  • Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable.
  • No evidence of active hepatitis C infection.
  • No evidence of active hepatitis B infection.
  • For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period.
  • Agreement not to seek pregnancy during the required study period.

Exclusion Criteria:

  • Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Use of long-acting ART within 3 months prior to enrollment.
  • Known resistance to any component of the current ART regimen (excluding M184V/I mutation).
  • Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation).
  • Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known).
  • History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count <200 cells/mm³ within the past 10 years.
  • History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy.
  • Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers).
  • Active hepatitis B or hepatitis C infection.
  • Significant liver disease, including cirrhosis or advanced fatty liver disease.
  • Untreated or incompletely treated active or latent tuberculosis.
  • Pregnancy or breastfeeding.
  • Body mass index (BMI) ≥40 kg/m², unless approved.
  • Diabetes mellitus, except well-controlled type 2 diabetes as allowed.
  • History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease.
  • Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).
  • Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed.
  • Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe.
  • Prior receipt of anti-HIV monoclonal antibody therapy.
  • Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks).
  • Receipt of other vaccines within 14 days prior to enrollment.
  • History of myocarditis or pericarditis.
  • Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).
  • Recent use of investigational agents within restricted timeframes prior to enrollment.
  • History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.
  • History of angioedema.
  • Idiopathic urticaria within the past year.
  • Chronic urticaria or urticaria within the past year.
  • History of urticaria associated with vaccination.
  • Bleeding disorders or use of systemic anticoagulants.
  • Conditions associated with increased risk of clotting or bleeding.
  • History of seizures within the past 3 years or use of anti-seizure medications within that period.
  • Absence of spleen or impaired splenic function.
  • Active duty or reserve military personnel (U.S.).
  • Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.
  • Uncontrolled or severe asthma.
  • History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.
  • Allergy to local anesthetics (e.g., lidocaine).
  • Difficulty with venous access that would interfere with study procedures.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Alapvető tudomány
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Szekvenciális hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Group 1

Participants will receive:

  • Week 0: DV700P-RNA
  • Week 8: DV700P-RNA
  • Week 16: DV701B1.1-RNA
Biológiai: DV700P-RNA 100 mcg
Intramuscular injection
Biológiai: DV701B1.1-RNA 100 mcg
Intramuscular injection
Kísérleti: Group 2

Participants will receive:

  • Week 0: DV700P-RNA
  • Week 8: DV701B1.1-RNA
Biológiai: DV700P-RNA 100 mcg
Intramuscular injection
Biológiai: DV701B1.1-RNA 100 mcg
Intramuscular injection

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Local reactogenicity following study product administration
Időkeret: 14 days following each vaccination
Incidence and severity of solicited local reactogenicity signs and symptoms (injection site pain, erythema, and swelling), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
14 days following each vaccination
Systemic reactogenicity following study product administration
Időkeret: 14 days following each vaccination
Incidence and severity of solicited systemic reactogenicity signs and symptoms (fever, fatigue, myalgia, arthralgia, headache, chills, nausea), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
14 days following each vaccination
Number and description of serious adverse events (SAEs)
Időkeret: Through study completion, expected to be up to 88 weeks
Through study completion, expected to be up to 88 weeks
Number and description of medically attended adverse events (MAAEs)
Időkeret: Through study completion, expected to be up to 88 weeks
Through study completion, expected to be up to 88 weeks
Number and description of adverse events of special interest (AESIs)
Időkeret: Through study completion, expected to be up to 88 weeks
Through study completion, expected to be up to 88 weeks
Number and description of adverse events leading to study product discontinuation or participant withdrawal
Időkeret: Through study completion, expected to be up to 88 weeks
Through study completion, expected to be up to 88 weeks
Number and description of adverse events (AEs) following study product administration
Időkeret: 30 days following each vaccination
30 days following each vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Proportion of participants with serum antibody responses demonstrating differential neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay
At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay
At Baseline (Week 0) and 2 weeks after last vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Proportion of participants with serum antibody responses demonstrating differential neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay
6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant viruses, as measured by TZM-bl pseudovirus assay
6 weeks after last vaccination and 8 weeks after ART restart

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Frequency of Env-specific and V3-glycan-specific B cells
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry
At Baseline (Week 0) and 2 weeks after last vaccination
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing
At Baseline (Week 0) and 2 weeks after last vaccination
Frequency of Env-specific and V3-glycan-specific B cells after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry
6 weeks after last vaccination and 8 weeks after ART restart
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing
6 weeks after last vaccination and 8 weeks after ART restart
Response rate of serum IgG binding antibodies to autologous HIV Env stabilized trimers
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Proportion of participants with serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of serum IgG binding antibodies to autologous HIV Env stabilized trimers
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
At Baseline (Week 0) and 2 weeks after last vaccination
Epitope specificity of serum IgG binding antibodies to autologous HIV Env stabilized trimers
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Epitope specificity of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
At Baseline (Week 0) and 2 weeks after last vaccination
Response rate of neutralization activity against heterologous tier 2 viruses
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Proportion of participants with neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of neutralization activity against heterologous tier 2 viruses
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
At Baseline (Week 0) and 2 weeks after last vaccination
Breadth of neutralization activity against heterologous tier 2 viruses
Időkeret: At Baseline (Week 0) and 2 weeks after last vaccination
Breadth of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
At Baseline (Week 0) and 2 weeks after last vaccination
Response rate of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Proportion of participants with serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
6 weeks after last vaccination and 8 weeks after ART restart
Epitope specificity of serum IgG binding antibodies to autologous HIV Env stabilized trimers after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Epitope specificity of serum IgG binding antibody responses to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
6 weeks after last vaccination and 8 weeks after ART restart
Response rate of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Proportion of participants with neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
6 weeks after last vaccination and 8 weeks after ART restart
Breadth of neutralization activity against heterologous tier 2 viruses after last vaccination and after ART restart
Időkeret: 6 weeks after last vaccination and 8 weeks after ART restart
Breadth of neutralizing responses against heterologous tier 2 viruses, as measured by TZM-bl pseudovirus assay
6 weeks after last vaccination and 8 weeks after ART restart
Change in HIV Env sequence characteristics during ATI
Időkeret: During ATI
Comparison of HIV envelope (Env) sequence evolution during analytic treatment interruption (ATI) between participants who develop V3-glycan-specific antibodies and those who do not
During ATI
Change in HIV gag sequence characteristics during ATI
Időkeret: During ATI
Comparison of HIV gag sequence evolution during analytic treatment interruption (ATI) between participants who develop V3-glycan-specific antibodies and those who do not
During ATI

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

National Institute of Allergy and Infectious Diseases (NIAID)

Együttműködők

Duke University
Department of Health and Human Services

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 15.

Elsődleges befejezés (Becsült)

2027. augusztus 31.

A tanulmány befejezése (Becsült)

2027. augusztus 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 15.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 1.

Első közzététel (Tényleges)

2026. május 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 14.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 11.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • HVTN 808
  • 39218 (Egyéb azonosító: DAIDS Document ID)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Igen

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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