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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年9月11日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

42

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35222
        • 募集
        • Alabama CRS (Site ID: 31788)
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30308
        • 募集
        • The Ponce de Leon Center CRS (Site ID: 5802)
        • コンタクト：
      • Decatur、Georgia、アメリカ、30030
        • まだ募集していません
        • The Hope Clinic of the Emory Vaccine Center CRS (Site #: 31440)
        • コンタクト：
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • 募集
        • Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)
        • コンタクト：
    • New York
      • New York、New York、アメリカ、10032
        • まだ募集していません
        • Columbia P&S CRS (Site#: 30329)
        • コンタクト：
      • Rochester、New York、アメリカ、14642
        • まだ募集していません
        • University of Rochester Vaccines to Prevent HIV Infection CRS (Site#: 31467)
        • コンタクト：
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • まだ募集していません
        • Penn Prevention CRS (Site#: 30310)
        • コンタクト：
    • Texas
      • Houston、Texas、アメリカ、77030-1501
        • まだ募集していません
        • Houston Advancing Research Team CRS (Site # 31473)
        • コンタクト：
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 募集
        • Seattle Vaccine and Prevention CRS (Site ID: 30331)
        • コンタクト：
  • アルゼンチン
    • Buenos Aires
      • Buenos Aires、Buenos Aires、アルゼンチン、C1427CEA
        • まだ募集していません
        • Fundacion Huesped CRS (Site ID: 31957)
        • コンタクト：
  • ジンバブエ
      • Harare、ジンバブエ
        • まだ募集していません
        • Seke South CRS/30294 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)
        • コンタクト：
      • Harare、ジンバブエ
        • まだ募集していません
        • Spilhaus CRS/30314 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC)
        • コンタクト：
  • ペルー
    • Lima Province
      • Lima、Lima Province、ペルー、15001
        • まだ募集していません
        • Via Libre CRS (Site ID: 31909)
        • コンタクト：
      • Lima、Lima Province、ペルー、15063
        • まだ募集していません
        • Barranco CRS (Site ID: 11301)
        • コンタクト：
          • Consuelo T. Ramirez
          • 電話番号：210 51-1-2067800
      • Lima、Lima Province、ペルー、15088
        • まだ募集していません
        • San Miguel CRS (Site ID: 11302)
        • コンタクト：
    • Provincia Constitucional del Callao
      • Bellavista、Provincia Constitucional del Callao、ペルー、07006
        • まだ募集していません
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
        • コンタクト：
          • Fanny G. Rosas Benancio
          • 電話番号：1007 51-1-4800401
          • メール：frosas@citbm.pe

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Group 1

Participants will receive:

  • Week 0: DV700P-RNA
  • Week 8: DV700P-RNA
  • Week 16: DV701B1.1-RNA
生物学的：DV700P-RNA 100 mcg
Intramuscular injection
生物学的：DV701B1.1-RNA 100 mcg
Intramuscular injection
実験的：Group 2

Participants will receive:

  • Week 0: DV700P-RNA
  • Week 8: DV701B1.1-RNA
生物学的：DV700P-RNA 100 mcg
Intramuscular injection
生物学的：DV701B1.1-RNA 100 mcg
Intramuscular injection

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Local reactogenicity following study product administration
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：30 days following each vaccination
30 days following each vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Frequency of Env-specific and V3-glycan-specific B cells
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Institute of Allergy and Infectious Diseases (NIAID)

協力者

Duke University
Department of Health and Human Services

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年4月15日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • HVTN 808
  • 39218 (その他の識別子：DAIDS Document ID)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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