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Assessing Vaccine Effectiveness of R21/Matrix-M Across Malaria Transmission Settings (AVERT) (AVERT)

2026年8月3日 更新者：Clinton Health Access Initiative Inc.

Real-World Effectiveness of the R21/Matrix-M Malaria Vaccine in Children in Burkina Faso and Uganda

The AVERT study is a prospective observational test-negative case control study evaluating the real-world effectiveness of the R21/Matrix-M malaria vaccine among children younger than 5 years in Burkina Faso and Uganda. Children who seek outpatient care with suspected malaria and are eligible for the national R21/Matrix-M vaccination program will be enrolled. Malaria infection will be determined by blood smear microscopy. Children with a positive microscopy result will be classified as cases and children with a negative result as controls. Vaccination history, including the number and timing of doses, will be obtained primarily from vaccination cards or other written records. Vaccine effectiveness will be estimated by comparing the odds of vaccination among cases and controls.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

R21/Matrix-M has been introduced through national immunization programs, but its effectiveness under routine conditions may differ from efficacy observed in clinical trials because children may receive different numbers of doses, doses may be delayed, protection may wane, and malaria transmission and other prevention measures vary across settings.

AVERT will use a prospective test-negative case-control design at approximately 22 outpatient health facilities in moderate- to high-transmission areas of Burkina Faso and Uganda. Consecutive children younger than 5 years who meet country definitions for suspected malaria, are eligible for R21/Matrix-M vaccination, and have caregiver consent will be enrolled. All participants will undergo malaria testing as part of routine care, with study blood smear microscopy used to assign case or control status. A structured caregiver questionnaire will collect demographic, clinical, residential, socioeconomic, health-care access, and malaria-prevention information. R21/Matrix-M dose number and vaccination dates will be verified primarily from vaccination cards, individual health records, or facility vaccination registers.

Cases and controls will be matched, when feasible, by geographic area and calendar time. Conditional or standard logistic regression will estimate adjusted odds ratios comparing vaccinated and unvaccinated children, and vaccine effectiveness will be calculated as (1 - adjusted odds ratio) x 100%. Analyses will be conducted separately by country and will assess effectiveness by dose, time since vaccination, dose spacing, transmission intensity, sex, and use of seasonal malaria chemoprevention, insecticide-treated nets, and indoor residual spraying. A health-system-perspective economic evaluation will estimate incremental cost per uncomplicated clinical malaria case averted.

研究类型

观察性的

注册 (估计的)

20000

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

  • 乌干达
    • Acholi
      • Kitgum、Acholi、乌干达
        • 尚未招聘
        • Kitgum-Matidi HCIII
        • 接触：
      • Kitgum、Acholi、乌干达
        • 尚未招聘
        • Namokora HCIV
        • 接触：
      • Omoro、Acholi、乌干达
        • 尚未招聘
        • Lalogi HCIV
        • 接触：
    • Bunyoro
      • Kikube、Bunyoro、乌干达
        • 尚未招聘
        • Rwenyawawa HCIII
        • 接触：
    • Busoga
      • Kaliro、Busoga、乌干达
        • 尚未招聘
        • Nawaikoke HCIII
        • 接触：
      • Mayuge、Busoga、乌干达
        • 尚未招聘
        • Kigandalo HCIV
        • 接触：
    • Karamoja
      • Moroto、Karamoja、乌干达
        • 尚未招聘
        • Nadunget HCIII
        • 接触：
    • Lango
      • Otuke、Lango、乌干达
        • 尚未招聘
        • Orum HCIV
        • 接触：
      • Oyam、Lango、乌干达
        • 尚未招聘
        • Otwal HCIII
        • 接触：
  • 布基纳法索
    • Boucle Mouhoun
      • Boromo、Boucle Mouhoun、布基纳法索
        • 招聘中
        • Boromo urbain 1
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Boromo、Boucle Mouhoun、布基纳法索
        • 招聘中
        • Ouahabou
        • 接触：
          • h Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
    • Hauts-Bassins Region
      • Houndé、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Béréba
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Houndé、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Dohoun
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Houndé、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Kari
        • 接触：
          • Halidou Tinto
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Déguélin
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Karangasso-Vigué
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Sourmousso
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、布基纳法索
        • 招聘中
        • Wara
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
    • Oubri
      • Zorgo、Oubri、布基纳法索
        • 招聘中
        • Mankarga T
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Zorgo、Oubri、布基纳法索
        • 招聘中
        • Mankarga V3
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf
      • Zorgo、Oubri、布基纳法索
        • 招聘中
        • Mankarga V6
        • 接触：
          • Halidou Tinto, PhD
          • 电话号码：+226 25 40 92 12
          • 邮箱：tintoh@crun.bf

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

  • 孩子

接受健康志愿者

不

取样方法

非概率样本

研究人群

Children younger than 5 years who reside in the catchment areas of selected health facilities in R21/Matrix-M implementation districts in Burkina Faso or Uganda, are age-eligible for vaccination under the relevant national schedule, and present for outpatient care with suspected malaria. Participants are recruited from health facilities in moderate- to high-transmission settings.

描述

Inclusion Criteria:

  • Residence in an area where R21/Matrix-M is implemented and within the catchment area of a selected study facility.
  • Younger than 5 years and eligibleto receive R21/Matrix-M under the national vaccination schedule at rollout.
  • Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing.
  • Written informed consent provided by an adult caregiver aged 18 years or older.

Exclusion Criteria:

  • Caregiver is unable or unwilling to provide informed consent.
  • Severe non-malaria illness at presentation that would interfere with study participation.
  • Repeat presentation within the protocol-defined exclusion window after a previous enrollment: within 14 days after a microscopy-positive visit; or more than 7 but fewer than 14 days after a microscopy-negative visit. A microscopy-negative visit followed by a positive diagnosis within 7 days will be reclassified as positive rather than treated as a new enrollment.
  • Documented receipt of any RTS,S malaria vaccine dose.

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

队列和干预

团体/队列
干预/治疗
Suspected malaria cases that test positive using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is positive for P. falciparum infection
生物：R21/Matris-M Malaria vaccine
R21/Matrix-M vaccination received through routine national immunization programs. The study will record the number and dates of doses received. Children will be classified as having received 0, 1, 2, 3, or 4 eligible doses, with prespecified grouped classifications used if individual dose categories are underpowered. Doses given fewer than 14 days before malaria testing will not count toward the primary exposure classification.
Suspected malaria cases that test negative using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is negative for P. falciparum infection
生物：R21/Matris-M Malaria vaccine
R21/Matrix-M vaccination received through routine national immunization programs. The study will record the number and dates of doses received. Children will be classified as having received 0, 1, 2, 3, or 4 eligible doses, with prespecified grouped classifications used if individual dose categories are underpowered. Doses given fewer than 14 days before malaria testing will not count toward the primary exposure classification.

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
Dose-specific effectiveness of R21/Matrix-M against microscopy-confirmed clinical malaria
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month study recruitment period
Adjusted vaccine effectiveness will be calculated as (1 - adjusted odds ratio) x 100%. The odds ratio will compare the odds of each documented R21/Matrix-M dose category among microscopy-positive malaria cases with the odds among microscopy-negative controls, using children with 0 doses as the primary reference group. Prespecified grouped dose categories will be used if individual dose categories do not have adequate statistical power.
At the enrollment illness episode, during the approximately 7- to 8-month study recruitment period

次要结果测量

结果测量
措施说明
大体时间
Effectiveness of R21/Matrix-M by time since vaccination
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Adjusted vaccine effectiveness will be estimated by categorical and/or continuous time since the most recent eligible vaccine dose, including interactions between dose and time.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification of vaccine effectiveness by malaria transmission intensity
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Dose-specific vaccine effectiveness will be compared across prespecified malaria transmission levels within each country.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification of vaccine effectiveness by sex
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Dose-specific vaccine effectiveness will be estimated using vaccination-by-sex interaction terms and sex-stratified analyses.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification by other malaria prevention interventions
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Dose-specific vaccine effectiveness will be assessed in relation to seasonal malaria chemoprevention, insecticide-treated net use, and indoor residual spraying using interaction analyses.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effectiveness according to vaccine dose timing
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Among vaccinated children, effectiveness will be compared for on-time and late vaccination and in analyses restricted to doses spaced 3 to 5 weeks apart. A late dose is defined as a dose received at least 2 weeks after the scheduled date.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effectiveness of the fourth dose relative to the three-dose primary series
大体时间：At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Adjusted vaccine effectiveness of 4 doses compared with 3 doses will be estimated using the odds of microscopy-confirmed malaria.
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period

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

Clinton Health Access Initiative Inc.

合作者

University of California, San Francisco
Institut de Recherche en Sciences de la Sante, Burkina Faso
Ministry of Health, Uganda
Ministry of Health, Burkina Faso
Infectious Diseases Research Collaboration, Uganda

调查人员

  • 首席研究员：Isabel Rodriguez-Barraquer, MD, PhD、University of California, San Francisco
  • 首席研究员：Halidou Tinto, PhD、Institut de Recherche en Sciences de la Santé (Burkina Faso)
  • 首席研究员：Joaniter Nankabirwa, MD, PhD、Infectious Diseases Research Collaboration, Kampala, Uganda

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 (实际的)

2026年7月14日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月3日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8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

  • AVERT-2026-01
  • INV-097482 (其他赠款/资助编号：Gates Foundation)
  • 2026-06-05 (其他赠款/资助编号：Givewell)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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.

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