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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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1

Participants will receive:

  • Week 0: DV700P-RNA
  • Week 8: DV700P-RNA
  • Week 16: DV701B1.1-RNA
生物：DV700P-RNA 100 mcg
Intramuscular injection
生物：DV701B1.1-RNA 100 mcg
Intramuscular injection
实验性的：Group 2

Participants will receive:

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Local reactogenicity following study product administration
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：30 days following each vaccination
30 days following each vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Frequency of Env-specific and V3-glycan-specific B cells
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

合作者

Duke University
Department of Health and Human Services

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2026年4月15日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • HVTN 808
  • 39218 (其他标识符：DAIDS Document ID)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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