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Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2) (ENABLE 2)

2026年6月12日 更新者：Hospital Universitario 12 de Octubre

A Phase 1/2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS in Combination With VRC07-523LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV

The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable.

The main questions it aims to answer are:

  • Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV?
  • Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?
  • How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone?
  • How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections?

Researchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression.

Participants will:

  • Continue taking standard oral ART.
  • Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks.
  • Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.
  • Have follow-up visits for 48 weeks.
  • Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

This Phase 1/2 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of subcutaneous (SC) ePGT121v1-LS and VRC07-523-LS administered as adjunctive therapy to standard antiretroviral therapy (ART) in infants living with HIV (ILHIV) in South Africa.

Although early ART initiation has significantly improved survival among infants with HIV, achieving sustained virological suppression during infancy remains challenging because of factors including limited pediatric formulations, adherence difficulties, high baseline viral loads, and treatment interruptions. Novel long-acting therapeutic strategies that simplify treatment delivery and enhance antiviral activity may improve outcomes in this vulnerable population.

Broadly neutralizing antibodies (bNAbs) have shown antiviral activity in adults and children living with HIV and may provide additional benefits through prolonged antiviral coverage and immunomodulatory effects. ePGT121v1-LS is a long-acting bNAb directed against the V3 glycan supersite of the HIV-1 envelope and VRC07-523-LS is a bNAb against the CD4 binding site. The LS mutation extends antibody half-life and supports infrequent dosing schedules using SC administration.

This study includes an initial safety lead-in phase followed by a randomized placebo-controlled phase evaluating ePGT121v1-LS and VRC07-523-LS in combination with standard ART. The trial will assess the safety profile and tolerability of repeated SC administrations and will characterize pharmacokinetic parameters following serial dosing in infants. In addition, the study will evaluate the antiviral effect of ePGT121v1-LS and VRC07-523-LS intensification therapy on HIV viral suppression during the first 48 weeks of follow-up.

Exploratory analyses will further assess virological, immunological, and reservoir-related outcomes, including HIV-1 DNA dynamics, anti-drug antibodies, biomarkers and immune responses associated with bNAb exposure. Qualitative assessments will also evaluate the acceptability and feasibility of SC bNAb administration from the perspective of caregivers, healthcare workers, and stakeholders.

The results of this study are intended to inform the development of future pediatric trials evaluating long-acting bNAb-based therapeutic strategies for infants living with HIV.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
73

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 阶段2
  • 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。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

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

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Infants from 1 to 365 days old at the time of enrolment.
  • Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.
  • Weight > 2.5 kg at enrolment.
  • ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).
  • Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).
  • Parent or legal guardian able to provide Informed consent (IC).

Exclusion Criteria:

  • Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.
  • Previous receipt of bNAbs against HIV.
  • Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.
  • Intravenous (IV) immunoglobulins received within 90 days before IMP administration.
  • Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:
  • Evidence of active tuberculosis (TB) disease at the time of enrolment.
  • Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.
  • Severe acute malnutrition with complications.
  • Severe neurological illness.
  • Hemodynamically significant severe congenital heart disease.
  • Active malignancies.
  • Life-threatening bleeding disorder.
  • Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy <14 days.
  • Unwillingness to have blood drawn
  • Unable to receive SC medications.
  • Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).

Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
有源比较器：ePGT121v1-LS and VRC07-523-LS
4 injections of the bNAb ePGT121v1-LS and 4 injections of and VRC07-523-LS, separated 12 weeks, plus antiretroviral treatment.
药品：Broadly neutralizing antibody (bNAb) ePGT121v1-LS
Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.
药品：Broadly neutralizing antibody (bNAb) VRC07-523-LS
Administration of subcutaneous ePGT121v1LS, 4 doses, separate 12 weeks away.
安慰剂比较：Placebo (saline)
4 injections of saline, separated 12 weeks, plus antiretroviral treatment.
药品：Saline (0.9% NaCl)
Administration of subcutaneous saline, 4 doses, separate 12 weeks away.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Safety (Serious adverse events)
大体时间：48 weeks
Proportion of participants experiencing SAEs throughout the whole trial.
48 weeks
Virological suppression
大体时间：48 weeks
  • Proportion of infants achieving virological suppression (plasma HIV-1 RNA < 40 copies/mL) at week 48, as well as over the 48 week follow-up period.
  • Time to first virological suppression, defined as the time from randomization to the first post-baseline measurement of plasma HIV-1 RNA < 40 copies/mL.
48 weeks
Time to virological suppression
大体时间：48 weeks
• Time to first virological suppression, defined as the time from randomization to the first post-baseline measurement of plasma HIV-1 RNA < 40 copies/mL.
48 weeks
Tolerability of the treatment (participants who discontinue)
大体时间：48 weeks
• Proportion of participants who discontinue due to toxicity or tolerability issues.
48 weeks
Tolerability of the injection
大体时间：1 hour
• Median score of pain assessment scale after administration of bNAb (FLACC scale).
1 hour

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
PK profile of ePGT121v1-LS and of VRC07-523-LS
大体时间：12 weeks
Half-life
12 weeks
Time to sustained virological suppression
大体时间：48 weeks
Time from randomization to the first scheduled post-baseline visit at which HIV-1 RNA is < 40 copies/mL, provided that all subsequent scheduled HIV-1 RNA measurements through week 48 also remain < 40 copies/mL.
48 weeks
Longitudinal virological response
大体时间：48 weeks
Proportion of participants with HIV-1 RNA < 40 copies/mL at weeks 12, 24, 36, and 48 will be recorded as the endpoint and log change in plasma HIV-1 RNA levels relative to baseline and subsequent pre-dose measurements.
48 weeks
Acceptability
大体时间：48 weeks
The acceptability will be assessed through a series of qualitative interviews and limited quantitative assessments.
48 weeks
Adverse events
大体时间：48 weeks
Number of and proportion of participants with solicited adverse event (AEs) and laboratory-related AEs.
48 weeks

其他结果措施

其他结果措施

对于临床试验，协议中描述的计划测量用于确定干预/治疗对参与者的影响。对于观察性研究，用于描述疾病或特征模式或与暴露、风险因素或治疗的关联的测量或观察。结果测量的类型包括主要结果测量和次要结果测量。
结果测量
措施说明
大体时间
All-cause mortality and number of hospitalizations.
大体时间：48 weeks
All-cause mortality and number of hospitalizations.
48 weeks
Clinical features at baseline and during follow-up
大体时间：48 weeks
This exploratory objective will include a comprehensive evaluation of different clinical parameters such as demographics (age, gestational age, weight, Prevention of Mother-To-Child Transmission (PMTCT) interventions), HIV disease severity (VL, CD4+ T-cell count/percentage), nutritional status, comorbidities (infectious and non-infectious), and ART (time to initiation, adherence during follow-up).
48 weeks
HIV-1 DNA
大体时间：48 weeks
The concentration of intact and defective HIV-1 proviral DNA, expressed as copies per million of peripheral blood mononuclear cells (PBMCs), measured by intact proviral DNA assay (IPDA) and quantified at baseline and week 48
48 weeks
Anti-drug antibodies (ADAs)
大体时间：48 weeks
The titers of ADAs will be quantified at baseline and week 48 to assess whether the development of host antibodies (anti-bNAbs) contributes to virological failure among infants who experience viral rebound by week 48, compared to infants with virological suppression at week 48.
48 weeks
Neutralizing Activity
大体时间：48 weeks
Neutralization titers will be calculated as IC50 (50% inhibitory concentration) and IC80 (80% inhibitory concentration) by TZM-bl luciferase reporter assay. In vitro susceptibility of env-pseudotyped viruses derived from all participants at baseline and from those experiencing breakthrough viremia at week 48 will be used to establish whether in vitro susceptibility predicts virological success
48 weeks
Immunophenotype
大体时间：48 weeks
Cellular immunophenotype will be measured using AIM-ICS flow cytometry to determine the activation status and cytokine production of T-cells and NK cells.
48 weeks
ADCC and intracellular p24 expression
大体时间：24 weeks
Change from baseline in bNAb-mediated effector function, as measured by ADCC assays, quantified by percentage of target cell lysis and percentage of activated NK cells (e.g., CD107a+) at predefined timepoints.
24 weeks
Biomarkers
大体时间：48 weeks
Association between sTREM-1 and adverse outcomes (mortality)
48 weeks

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

赞助

发起研究并有权和控制研究的组织或个人。
Hospital Universitario 12 de Octubre

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
University of Rome Tor Vergata
International AIDS Vaccine Initiative
University of Witwatersrand, South Africa
PENTA Foundation
Centro de Investigação em Saúde de Manhiça
Barcelona Institute for Global Health
Eduardo Mondlane University
Africa Health Research Institute
Faculty of Medical Sciences, Radboud University of Medical Center
Centre Pasteur du Cameroun
Servicio Madrileño de Salud (SERMAS)
Fundaçao Ariel Glaser contra o SIDA Pediatrico

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)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2027年1月1日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2029年7月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2029年12月31日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年6月9日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年6月12日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年6月17日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年6月17日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年6月12日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • 101190620_2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible after the end of the project in an open repository upon request.

IPD 共享时间框架

The individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible after the end of the project in an open repository upon request.

IPD 共享访问标准

Upon reasonable request.

IPD 共享支持信息类型

  • 研究方案
  • 树液

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

HIV -1 感染的临床试验

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赞助者和合作者

医疗条件

药物干预

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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