Project description
Clinical trial for mpox vaccine
Mpox, a viral disease caused by the monkeypox virus and characterised by flu-like symptoms and a distinctive rash, has recently seen a resurgence outside its traditional endemic regions. Because it can cause severe complications in vulnerable groups such as pregnant women, newborns and young infants, there is a need for targeted public health interventions and vaccine trials. The EU-cofunded PregInPoxVac project is undertaking a clinical trial to assess the safety and immunogenicity of the MVA-BN vaccine in pregnant women, newborns and young infants. The MVA-BN vaccine uses a modified vaccinia Ankara (MVA) virus as its base and has been used to protect against smallpox. The project will also address vaccine hesitancy in a bid to improve uptake in high-risk groups.
Objective
Mpox can cause severe complications in vulnerable groups such as pregnant women and children, necessitating targeted public health interventions and vaccine trials in these populations. Limited data suggest the MVA-BN vaccine is safe for pregnant women and likely poses no risk to breastfed infants, but comprehensive human data are lacking. Trials in endemic areas are crucial for evaluating the vaccine's safety and efficacy in real-world settings.
Vaccine hesitancy, exacerbated by misinformation and distrust in healthcare systems, poses a significant challenge, especially in the Democratic Republic of the Congo. Pregnant women are particularly affected by concerns about vaccine safety, which influences their willingness to vaccinate. Addressing these concerns through targeted communication and community engagement is vital.
A proposed phase 3, randomized trial will assess the safety and immunogenicity of the MVA-BN vaccine in healthy pregnant and postpartum women and in infants/children (6-24 months old). Additionally, a qualitative study on vaccine hesitancy will inform the trial design and implementation, aiming to enhance vaccination uptake in these high-risk groups.
Fields of science (EuroSciVoc)
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2024-Mpox
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
2000 Antwerpen
Belgium
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.