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SE36/cVLP

SEmalvac6

at a glance

TARGET DISEASE

Malaria | Blood stage

TIMELINE

01 April 2025- 31 March 2027

COORDINATOR

European Vaccine Initiative

FUNDER

Global Health Innovative Technology Fund (GHIT)

FUNDING

800,715,002 JPY

SUMMARY

Biomanufacture and preclinical development of the blood-stage malaria vaccine candidate SE36/cVLP

Despite global efforts, malaria remains one of the leading causes of death among children under five in sub-Saharan Africa. Current vaccines target only one stage of the Plasmodium falciparum life cycle, which limits their overall effectiveness.
This project, based on the results of GHIT-funded projects (G2013-105, G2014-109, G2016-106, G2019-208), focuses on the development of SE36/cVLP, a next-generation blood-stage malaria vaccine candidate based on the N-terminal domain of the P. falciparum SERA5 antigen.
The SE36 antigen has previously been tested in phase I clinical trials in combination with two different adjuvants. In addition, the SE36/cVLP construct was produced in lab-scale batches and showed high immunogenicity in preclinical rat models.
The use of the Corynex® expression system allows for efficient and cost-effective production of SE36, supporting large-scale deployment in endemic regions.

SE36/cVLP can be used independently or in combination with multi-stage vaccines to elicit a broader and more robust immune response. This approach represents a promising step toward a more effective, accessible, and affordable malaria vaccine.
The main objectives are to:
- Manufacture a large GMP batch of SE36  
- Produce a GMP batch of SE36/cVLP  
- Conduct a GLP-compliant nonclinical toxicology study for SE36/cVLP + Sepivac SWE adjuvant 
- Prepare clinical trial documentation for the conduct of a phase I/IIa (CHMI) trial for SE36/cVLP (+/- Sepivac SWE) to assess safety, immunogenicity, and time-to-first episode of clinical malaria in malaria-naïve vaccinated subjects.

SEmalvac6

PARTNERS

AdaptVac, Ajinomoto Co., Inc., Eberhard Karls Universität of Tübingen (EKUT), European Vaccine Initiative (EVI) (Germany), Nobelpharma Co., Ltd. (NPC), RIMD Osaka University (OU), University of Copenhagen (UCPH)

Global Health Innovative Technology Fund (GHIT)

This project has received funding from Global Health Innovative Technology Fund (GHIT).

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