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O estudo clínico NCT06860178 (IMVACS) para Malaria Vaccine está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa (IMVACS)

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06860178 (IMVACS) procura avaliar a prevenção para Malaria Vaccine. Este é um ensaio intervencionista de Fase IV. Seu status atual é: recrutando. O estudo começou em 10 de junho de 2025 e pretende incluir 40.000 participantes. Coordenado por Epicentre e deve ser concluído em 1 de dezembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 8 de agosto de 2025.
Resumo
This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness.

Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.

Título oficial

Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

Condições
Malaria Vaccine
Outros IDs do estudo
  • IMVACS
Número NCT
NCT06860178
Data de início (real)
2025-06-10
Última atualização postada
2025-08-08
Data de conclusão (estimada)
2027-12
Inscrição (estimada)
40.000
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Recrutando
Palavras-chave
malaria
CPS
pediatric
vaccine
R21
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Nenhuma intervençãoControl Arm
Children aged 5-36 months will receive R21 via routine EPI vaccination (Year round in Burkina faso, or prior to the malaria season and SMC delivery in Mali)
N/A
OutroIntegrated SMC Vaccination
Children aged 3-59 months will receive 3-dose primary series aligned with SMC distribution in an annual campaign
Annual Campaign of the 3-Dose Primary Series Vaccine R21/MATRIX-M Aligned with SMC Distribution in Children Aged 3-59 Months
in the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Malaria Incidence on 5-36 months at 12 months
Malaria incidence among children aged 5-36 months over 12 months post first dose using routine surveillance activities for clinical malaria detection and reporting
from enrollment to 12 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Malaria incidence among children aged 5-36 months over 24 and 36 months
Malaria incidence among children aged 5-36 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting;
From enrollment to 2 years after booster
Malaria incidence among children aged 3-59 months over 24 and 36 months
Malaria incidence among children aged 3-59 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting
From enrollment to 2 years after booster
Malaria prevalence at peak transmission
Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026
From enrollment to 2 years after booster dose
Vaccine coverage
Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination
From enrollment to months 24
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination
From enrollment to months 4
Acceptability
Qualitative interviews and FGDs among policy makers, health managers, health providers and caregivers
From 12 months after study start to 36 months
Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group
Acceptability and feasibility studies will use qualitative longitudinal study (QLS) research methods. We will apply an ecological framework approach with emphasis on the interplay and inter-dependency between individual, interpersonal, organizational, and policy levels. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions. No quantitative measurements will be made.
From enrollment to months 36
Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake
Interviews and FGD - will be explained in a parallel protocol
From enrollment to months 24
Stakeholders and caregivers perceptions of the factors that enhance and/or constrain the succesful co,pletion of four doses of R21 and the key drivers of vaccination coverage
The study will cover a full, two-year R21/Matrix-M delivery cycle with data collection at two time points in each arm: soon after the primary series is delivered, and soon after the booster dose is provided a year later. This longitudinal approach will enable us to explore and chart dynamic processes as they occur, barriers and facilitators, and acceptability over time. It is inherently suitable for studying R21/Matrix-M introduction, requiring prolonged and repeated involvement by patients and providers. This approach is also necessary to explore the drivers of vaccine hesitancy which is not a static state; vaccine decision-making changes over time as caregivers experience different influences and nudges along the way. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions to explore factors in the service delivery, household, and broader social environments that will lead to R21 adoption and adherence. A
From enrollment to months 24 and 36
Incremental costs (per child vaccinated) and cost-effectiveness (per malaria case and separately, per DALY averted) of each vaccination strategy, calculated from a societal perspective
Costs associated with the different vaccination strategies will be estimated by collecting data on direct and indirect costs to health systems and opportunity costs to vaccinees and their caregivers (beneficiaries). Beneficiary costs will be collected during household surveys, via case report forms developed to collect data on direct costs (transport, food, medication) and indirect costs (time and income loss) incurred by their household related to each intervention arm. Provider costs will be collected using custom built spreadsheets structured to comprehensively capture the resources used for all intervention delivery related activities (excluding research activities) by cost category (person time, equipment, consumables including vaccines, storage, transport, overheads and other costs) by arm. Malaria incidence estimates (primary clinical outcome) will be used to calculate malaria cases and DALYs averted by arm, adjusted for intervention coverage (using the coverage survey data).
From enrollment to months 36
Critérios de elegibilidade

Idades elegíveis
Criança
Idade mínima
3 Months
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim

Control arms :

  • Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;
  • Resident in the catchment area of a health centre assigned to the control arm;
  • Willingness to comply with the study procedures;
  • Written informed consent from Parent/Guardian.

Intervention arms :

  • Children aged 3-59 months at the time of first study vaccination;
  • Resident in the catchment area of a health centre assigned to the intervention arm;
  • Willingness to comply with the study procedures;
  • Written informed consent from Parent/Guardian.

  1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
  2. Any history of anaphylaxis in relation to vaccination;
  3. Known chronic illness;
  4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
  5. History of vaccination with another malaria vaccine. -
Epicentre logoEpicentre
  • 🏛️R-Evolution Worldwide
  • 🏛️CNRST Burkina Faso
  • 🏛️USTTB Mali
  • ⚕️Liverpool School of Tropical Medicine
Contato central do estudo
Contato: Valérie Briand, +331 40 21 55 55, [email protected]
Contato: Soazic Gardais, +331 40 21 55 55, [email protected]
2 Locais do estudo em 2 países
Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest, Ouagadougou, Burkina Faso
Natama Hamtandi Magloire, Contato, +226 57471950, [email protected]
Natama Hamtandi Magloire, Investigador principal
Recrutando
University of Sciences Techniques and Technologies of Bamako, Bamako, Mali
Kassoum Kayentao, Contato, +223 76460173, [email protected]
Kassoum Kayentao, Investigador principal
Recrutando