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A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate

NCT07124156 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-21

No results posted yet for this study

Summary

The goal of the study is to test the efficacy using a homologous CHMI of this vaccine candidate early in the development path in a population living in malaria-endemic areas.

In the previous Phase Ia and Ib trials, no efficacy endpoints were defined, and therefore there is currently no data on the SUM-101 vaccine efficacy. The proposed clinical trial will enrol malaria pre-exposed healthy adults and will be the second trial where the IMP will be administered to healthy adult participants in Tanzania with some pre-existing immunity against malaria.

The vaccination part of this study will be performed in a randomised, double-blinded, controlled design to evaluate the safety, reactogenicity and immunogenicity of the candidate malaria vaccine SUM-101 (MSP1 with GLA-SE as adjuvant). Given that SUM-101 is a malaria vaccine with an important blood-stage component, we propose to use CHMI with the 3D7 P. falciparum strain-infected red blood cells to establish initial vaccine efficacy data after the third vaccination in a malaria-exposed population.

Conditions

  • Malaria Fever

Interventions

BIOLOGICAL

SUM-101

Once randomised to either the SUM-101 or the rabies control vaccine, the participant will always receive the same dose of the same compound (150 µg MSP1 protein dissolved in 0.9% NaCl with 250 µl (5µg) of adjuvant GLA-SE and there are no dose adjustments foreseen. The three vaccine doses will be applied in 4-week intervals on day 0, day 28 and day 56.

OTHER

CHMI

Experimental intervention: The participants will receive a target dose of 2,800 viable intraerythrocytic P. falciparum 3D7 parasites, in a volume of 2 mL injectable saline. The erythrocytes will be thawed, resuspended and viability will be calculated. The total erythrocyte number will be between \~3.9×106 and \~5.2×108 (average: \~4.55×108) per dose with ≥80% (\~3.64×108) P. falciparum ring-stage parasites and around 34% (\~1.24×108) viability. This number of viable P. falciparum ring-stage parasites will be diluted to establish 2800 per syringe that will be administered. Challenge dose will be administered to all volunteers as an intravenous injection at the clinical site following instructions in an established SOP. The parasites injected in each volunteer will be quantified retrospectively using qPCR analysis. The parasites injected in each volunteer will be quantified retrospectively using qPCR analysis. No dose adjustments are foreseen. As described in the protocol

BIOLOGICAL

Verorab®

Once randomised the participant will receive the or Verorab® and there are no dose adjustments foreseen. The three vaccine doses will be applied in 4-week intervals on day 0, day 28 and day 56.

Sponsors & Collaborators

  • Luxembourg Institute of Health

    collaborator OTHER_GOV

  • Ifakara Health Institute

    collaborator OTHER

  • European Vaccine Initiative

    lead OTHER

Principal Investigators

  • Ally Olotu, MD · Ifakara Health Institute (IHI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2026-07-31
Completion
2026-12-31

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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 NCT07124156 on ClinicalTrials.gov