Safety, reactogenicity, immunogenicity and parasite growth rates after controlled human malaria infection of malaria vaccine SumayaVac-1 (MSP-1 with GLA-SE adjuvant) in health adults in Tanzania

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 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 the 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. It will also employ the Controlled Human Malaria Infection model to evaluate the ability of this vaccine candidate to induce immune responses that prevent malaria parasites from getting into the red blood cells thereby preventing the development of malaria.

Study type: Interventional
Enrollment: 40 participants
Primary purpose: Prevention
Allocation:Randomized
Interventional Model: Parellel assignment
Masking :Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT05644067
Phase: Phase I

Clinical trial registration

Vaccines (Immune Correlates)

Aug 2023 — Jul 2024

Tanzania