이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 8월 3일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

20000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 부키 나 파소
    • Boucle Mouhoun
      • Boromo, Boucle Mouhoun, 부키 나 파소
        • 모병
        • Boromo urbain 1
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Boromo, Boucle Mouhoun, 부키 나 파소
        • 모병
        • Ouahabou
        • 연락하다:
          • h Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
    • Hauts-Bassins Region
      • Houndé, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Béréba
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Houndé, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Dohoun
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Houndé, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Kari
        • 연락하다:
          • Halidou Tinto
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Karangasso-Vigué, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Déguélin
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Karangasso-Vigué, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Karangasso-Vigué
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Karangasso-Vigué, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Sourmousso
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Karangasso-Vigué, Hauts-Bassins Region, 부키 나 파소
        • 모병
        • Wara
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
    • Oubri
      • Zorgo, Oubri, 부키 나 파소
        • 모병
        • Mankarga T
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Zorgo, Oubri, 부키 나 파소
        • 모병
        • Mankarga V3
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
      • Zorgo, Oubri, 부키 나 파소
        • 모병
        • Mankarga V6
        • 연락하다:
          • Halidou Tinto, PhD
          • 전화번호: +226 25 40 92 12
          • 이메일: tintoh@crun.bf
  • 우간다
    • Acholi
      • Kitgum, Acholi, 우간다
        • 아직 모집하지 않음
        • Kitgum-Matidi HCIII
        • 연락하다:
      • Kitgum, Acholi, 우간다
        • 아직 모집하지 않음
        • Namokora HCIV
        • 연락하다:
      • Omoro, Acholi, 우간다
        • 아직 모집하지 않음
        • Lalogi HCIV
        • 연락하다:
    • Bunyoro
      • Kikube, Bunyoro, 우간다
        • 아직 모집하지 않음
        • Rwenyawawa HCIII
        • 연락하다:
    • Busoga
      • Kaliro, Busoga, 우간다
        • 아직 모집하지 않음
        • Nawaikoke HCIII
        • 연락하다:
      • Mayuge, Busoga, 우간다
        • 아직 모집하지 않음
        • Kigandalo HCIV
        • 연락하다:
    • Karamoja
      • Moroto, Karamoja, 우간다
        • 아직 모집하지 않음
        • Nadunget HCIII
        • 연락하다:
    • Lango
      • Otuke, Lango, 우간다
        • 아직 모집하지 않음
        • Orum HCIV
        • 연락하다:
      • Oyam, Lango, 우간다
        • 아직 모집하지 않음
        • Otwal HCIII
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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
생물학적: 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
생물학적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Dose-specific effectiveness of R21/Matrix-M against microscopy-confirmed clinical malaria
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Effectiveness of R21/Matrix-M by time since vaccination
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Clinton Health Access Initiative Inc.

협력자

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

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 14일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2026년 8월 3일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AVERT-2026-01
  • INV-097482 (기타 보조금/기금 번호: Gates Foundation)
  • 2026-06-05 (기타 보조금/기금 번호: Givewell)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다