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A Phase 2a Randomised Clinical Trial to Identify the Optimal Dose of the Thermostable ID93+GLA-SE Tuberculosis Vaccine for Further Clinical Evaluation and Local Manufacture in Africa

Cel

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

Dziedzina nauki (EuroSciVoc)

Słowa kluczowe

Program(-y)

Temat(-y)

System finansowania

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Zaproszenie do składania wniosków

(odnośnik otworzy się w nowym oknie) HORIZON-JU-GH-EDCTP3-2025-01-two-stage

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Koordynator

STICHTING TUBERCULOSIS VACCINE INITIATIVE
Wkład UE netto
€ 825 000,00
Koszt całkowity
€ 850 000,00

Uczestnicy (6)