Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country

Summary

Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria vaccine approved for use in the pediatric population, which provides a moderate and short-lived protection. Therefore, there is a need to develop a malaria vaccine that will be essential to further strengthen malaria control measures in future. A Phase Ia trial with the same IMP (SumayaVac-1 vaccine developed using a full-length recombinant MSP-1 administered along with the adjuvant GLA-SE) in Caucasians in Heidelberg, Germany, proved to be well tolerated and safe. However, a Phase Ib clinical trial on healthy participants residing in a malaria endemic country would be essential to evaluate the safety and reactogenicity in the target population. The project aims to investigate the safety, reactogenicity, immunogenicity of the candidate malaria vaccine, SumayaVac-1 (SUM-101) in 40 healthy participants (men and women) of African origin in Bagamoyo, Tanzania.

Timeline

Start

2023-08-25

Primary completion

2024-04-02

Completion

2024-04-02

Publications

• Background Blank A, Furle K, Jaschke A, Mikus G, Lehmann M, Husing J, Heiss K, Giese T, Carter D, Bohnlein E, Lanzer M, Haefeli WE, Bujard H. Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial. NPJ Vaccines. 2020 Jan 31;5(1):10. doi: 10.1038/s41541-020-0160-2. eCollection 2020.
• Kahatano AE, Mpina M, Vanobberghen F, Hassan O, Urasa N, Sasamalo I, Mswata S, Paris D, Gajewski S, Saxena M, Furle K, Kiehl V, Bohnlein E, Aschenbrenner A, Lanzer M, Thomson-Luque R, Olotu A, Daubenberger C. Full-length merozoite surface protein 1 formulated with GLA-SE adjuvant in malaria pre-exposed adults: a randomised, controlled, double-blind, parallel-group, single-centre Phase Ib trial. EClinicalMedicine. 2025 Oct 25;89:103585. doi: 10.1016/j.eclinm.2025.103585. eCollection 2025 Nov.

Drugs

Indications