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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

20000

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

  • ウガンダ
    • Acholi
      • Kitgum、Acholi、ウガンダ
        • まだ募集していません
        • Kitgum-Matidi HCIII
        • コンタクト：
      • Kitgum、Acholi、ウガンダ
        • まだ募集していません
        • Namokora HCIV
        • コンタクト：
      • Omoro、Acholi、ウガンダ
        • まだ募集していません
        • Lalogi HCIV
        • コンタクト：
    • Bunyoro
      • Kikube、Bunyoro、ウガンダ
        • まだ募集していません
        • Rwenyawawa HCIII
        • コンタクト：
    • Busoga
      • Kaliro、Busoga、ウガンダ
        • まだ募集していません
        • Nawaikoke HCIII
        • コンタクト：
      • Mayuge、Busoga、ウガンダ
        • まだ募集していません
        • Kigandalo HCIV
        • コンタクト：
    • Karamoja
      • Moroto、Karamoja、ウガンダ
        • まだ募集していません
        • Nadunget HCIII
        • コンタクト：
    • Lango
      • Otuke、Lango、ウガンダ
        • まだ募集していません
        • Orum HCIV
        • コンタクト：
      • Oyam、Lango、ウガンダ
        • まだ募集していません
        • Otwal HCIII
        • コンタクト：
  • ブルキナファソ
    • Boucle Mouhoun
      • Boromo、Boucle Mouhoun、ブルキナファソ
        • 募集
        • Boromo urbain 1
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Boromo、Boucle Mouhoun、ブルキナファソ
        • 募集
        • Ouahabou
        • コンタクト：
          • h Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
    • Hauts-Bassins Region
      • Houndé、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Béréba
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Houndé、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Dohoun
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Houndé、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Kari
        • コンタクト：
          • Halidou Tinto
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Déguélin
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Karangasso-Vigué
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Sourmousso
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Karangasso-Vigué、Hauts-Bassins Region、ブルキナファソ
        • 募集
        • Wara
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
    • Oubri
      • Zorgo、Oubri、ブルキナファソ
        • 募集
        • Mankarga T
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Zorgo、Oubri、ブルキナファソ
        • 募集
        • Mankarga V3
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf
      • Zorgo、Oubri、ブルキナファソ
        • 募集
        • Mankarga V6
        • コンタクト：
          • Halidou Tinto, PhD
          • 電話番号：+226 25 40 92 12
          • メール：tintoh@crun.bf

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

  • 子

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

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

コホートと介入

グループ/コホート
介入・治療
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
生物学的：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
生物学的：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.

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
Dose-specific effectiveness of R21/Matrix-M against microscopy-confirmed clinical malaria
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Effectiveness of R21/Matrix-M by time since vaccination
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

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

Clinton Health Access Initiative Inc.

協力者

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

捜査官

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

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 (実際)

2026年7月14日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月3日

最初の投稿 (実際)

2026年8月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月6日

QC基準を満たした最後の更新が送信されました

2026年8月3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

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AVERT-2026-01
  • INV-097482 (その他の助成金/資金番号：Gates Foundation)
  • 2026-06-05 (その他の助成金/資金番号：Givewell)

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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