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

NCT05644067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SumayaVac-1(SUM-101)

One immunization every 4 weeks for 3 months (total 3 immunizations)

BIOLOGICAL

Verorab

One immunization every 4 weeks for 3 months (total 3 immunizations)

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Sumaya Biotech GmbH & Co. KG

    collaborator UNKNOWN

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Claudia Daubenberger, PhD · Swiss Tropical & Public Health Institute

  • Ally Olotu, MD · Ifakara Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2024-04-02
Completion
2024-04-02

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644067 on ClinicalTrials.gov