Objective
The proposed project ACTTIVAC’s objectives are
1. Manufacture and co-lyophilisation of the ID93 antigen and GLA-SE adjuvant according to Good Manufacturing Practices, ensuring quality and regulatory compliance,
2. Generation of safety and immunogenicity data in humans to identify the optimal dose of the lyophilised ID93+GLA-SE TB vaccine for Mycobacterium tuberculosis (MTB)-sensitised adolescents and adults, in preparation for a planned phase 2b efficacy trial in this population,
3. Implementation of clinical research capacity development to contribute to the development of a sustainable clinical research workforce in Africa by strengthening local capacity in clinical trial operations, TB vaccinology and product development, and laboratory proficiency,
4. Technology transfer of the adjuvant production to enable local manufacture of clinical trial material in TB-endemic African countries to ensure sustainable vaccine supply post-licensure and
5. Evaluation of the thermostability of the lyophilised ID93+GLA-SE under field conditions to ensure that the vaccine is thermostable when stored at room temperature for at least 6 months.
The proposed project will contribute to Global Health EDCTP3’s overall goals of accelerating clinical evaluation of interventions for poverty-related infectious diseases in Sub-Saharan Africa (SSA) and building local research capacity. More specifically, the proposed project aligns with the EDCTP3’s 2025 Work Programme to develop vaccines for reducing TB disease burden in Sub-Saharan Africa through research and innovation. The proposed project will deliver three expected outcomes for the 2025 Work Programme:
1. Evidence of immunogenicity and safety for the optimal dose of the lyophilised ID93+GLA-SE vaccine candidate,
2. Clinical data on this prophylactic TB vaccine candidate for MTB-sensitised adolescents and adults and
3. Data on dosing and regimen of this lyophilised TB vaccine candidate for use in future vaccination
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
- social sciences economics and business business and management employment
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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-EDCTP3-2025-01-two-stage
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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.
8219 PK Lelystad
Netherlands
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.