Malaria FeverPhase 1CHMI-SUM-101NCT07124156
A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate
A Phase 1 study testing SUM-101, CHMI and Verorab® in people with Malaria Fever, run by European Vaccine Initiative.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Malaria Fever
- What is being tested?
- SUM-101, CHMI and Verorab®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent obtained before any study procedure.
- Literate participants aged ≥18 - ≤45 years of African origin.
- Female and male participants willing to practice effective contraception from 4 weeks before 1st vaccination (female participants only) and up to 12 weeks after the last vaccination or CHMI (female and male participants)
- Female participants must be willing to undergo multiple serum pregnancy tests.
- Available to participate in follow-up for the duration of the study, including the CHMI in-patient confinement period.
- Contactable by phone during the whole study period.
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- At least two years of residence in the Bagamoyo district or nearby districts in the Coastal and Dar-es-Salaam regions and planning to reside there for at least 9 more months.
- Agreement to provide personal contact information and contact information of another household member or close friend.
- Confirmation of understanding of design, procedures, risks and benefits of the study by scoring 10 out of 10 in a structured ten questions with a maximum of two attempts.
- General good health based on assessment of medical history and clinical examination.
- The volunteer agrees to refrain from blood donation for 12 months following CHMI.
- Volunteer agrees to refrain from intensive physical exercise (disproportionate to the volunteer's usual daily activity or exercise routine) during the malaria challenge period.
Who cannot join
- Previous participation in any malaria vaccine trial in the last 3 years.
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
- Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
- Previous vaccination with a rabies vaccine.
- High anti-schizont antibody level as measured by ELISA at screening.
- Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.
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- Known hypersensitivity to any of the vaccine components (adjuvant or protein) or anti-malarial treatments.
- Body mass index (BMI) of ≤18 or ≥30 Kg/m2.
- Participants are unable to be closely followed for social, geographic or psychological reasons.
- Any vaccination from 4 weeks prior to the 1st vaccination and (none planned) up to 8 weeks after the 3rd vaccination.
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, neurological, psychiatric, allergy, endocrine, malignant, haematological, infectious disease, epilepsy and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the participants.
- Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, clinically significant arrhythmias, left bundle branch block, secondary or tertiary A-V (atrio-ventricular) heart block.
- Any clinically significant laboratory values at screening outside of normal ranges for study participants.
- Malaria positivity at screening (microscopy or qPCR positive).
- Positive HIV, Hepatitis B (HBV) or Hepatitis C (HCV) tests. (The testing will only be requested on the discretion of clinician)
- For females: Positive pregnancy test or actively breastfeeding.
- Any recent or current systemic therapy with an antibiotic or drug with potential antimalarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (allowable time frame for use at investigators discretion or within a month prior to 1st vaccination or CHMI )
- History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, artemether-lumefantrine, Primaquine or history of severe (allergic) reactions to blood transfusion.
- Being an employee or relative of an employee of Ifakara Health Institute.
- Any other condition or situation that would, in the opinion of the investigator, place the volunteer at an unacceptable risk of injury or render the volunteer unable to meet the requirements of the protocol
About this study
Official title: A Randomised Phase Ib Trial to Assess the Blood-stage Efficacy of SUM-101 Malaria Vaccine in Adults Residing in Malaria-endemic Settings, After Controlled Human Malaria Infection Using 3D7 P. Falciparum Blood-stage Malaria Infection
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.
Read the detailed description
Full-length MSP1/GLA-SE (SUM-101) malaria vaccine (formerly SumayaVac-1) has been developed by Sumaya Biotech, a spin-off from Heidelberg University, Germany. SUM-101 is a vaccine based on the 3D7 strain (D-form) of full-length merozoite surface protein 1 (full-length MSP1). The full-length MSP1 is expressed as a recombinant heterodimeric protein in E. coli and lyophilised at 150 μg/vial. The lyophilised MSP1 protein is stored at 2 - 8°C. The adjuvant, GLA-SE, was developed by Access to Advanced Health Institute (AAHI), a Washington non-profit corporation with offices at 1616 Eastlake Ave. E, Suite 400, Seattle, WA 98102, USA. It is a stable oil-in-water emulsion containing a synthetic analogue of bacterial glucopyranosyl lipid A and functions as a toll-like receptor 4 agonist. A vial of the adjuvant contains 20μg of GLA-SE in a 400μl emulsion. GLA-SE adjuvant and emulsion formulations should be stored at 2 - 8°C.
The vaccine (SUM-101) is prepared before administration by reconstituting the lyophilised protein in saline (aqueous 0.9% NaCl) and then combining it with the GLA-SE adjuvant. The formulated vaccine is stable at room temperature for up to 60 minutes and administered intramuscularly.
A Phase I first-in-human, double-blinded, randomised trial (PMC6994672) was conducted to assess the safety and immunogenicity of SUM-101 in healthy malaria-naïve adult volunteers in Heidelberg, Germany. The trial demonstrated that SUM-101 is safe, with no serious adverse events (SAE) reported. Vaccination with SUM-101 induced MSP1 specific IgG and IgM antibodies that activated Fc-mediated effector mechanisms and were equally reactive against the vaccine variant (MSP1D/3D7) and a heterologous variant of MSP1 (MSP1F/FCB1). In addition, a Phase Ib trial was conducted in Bagamoyo, Tanzania (NCT05644067, data not yet published) where 20 healthy Tanzanian adults were vaccinated with SUM-101. Preliminary results indicate that SUM-101 is safe and well-tolerated in healthy African adults living in malaria-endemic areas, with ongoing assessments of antibody responses.
Concurrently with this trial, a Phase Ib, randomised, controlled age de-escalation, dose-finding study to evaluate the safety, reactogenicity and immunogenicity of full-length MSP1/GLA-SE (SUM-101) malaria vaccine in healthy young children, and infants (NCT06618885) will be conducted in Burkina Faso. The protocol has been submitted for ethical and regulatory approval in Burkina Faso.
- Conditions
- Malaria Fever
- Being tested
- SUM-101, CHMI, Verorab®
- Keywords
- SUM-01, CHMI, Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUM-101Biological
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.
CHMIOther
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
Verorab®Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Three dose SUM-101 | Experimental | Twelve participants will receive three monthly inoculations (on D0, D28 and D56) with the IMP, SUM-101. Receives: Biological: SUM-101; Other: CHMI |
| Three dose Verorab | Active comparator | 12 participants will receive three monthly inoculations (on D0, D28 and D56) with the IMP Verorab® Receives: Other: CHMI; Biological: Verorab® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy- Time to diagnosis
Blood-stage efficacy of the SUM-101 vaccine against 3D7 clone parasites in a CHMI model in healthy malaria-exposed adult volunteers, measured as time to diagnosis in the vaccine arm compared to controls. Time to diagnosis is defined as the number of days from challenge to treatment
Measured: From Day 84 to Day 168
Frequency of local and systemic solicited adverse events
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by the frequency of local and systemic solicited adverse events (AEs)
Measured: After each vaccination (done on Day 0, Day 28 and Day 56) up to 7 days post-vaccination
Frequency of local and systemic unsolicited adverse events
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by the frequency of local and systemic unsolicited adverse events
Measured: After each vaccination (done on Day 0, Day 28 and Day 56) up to 28 days post-vaccination
Frequency of any serious adverse events (SAE)
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by any serious adverse events (SAE)
Measured: Baseline (Day 0 before 1st vaccination) to end of the follow up (Day 168)
Number of participants with treatment-related adverse events as assessed by safety laboratory measures of haematology and biochemistry.
Number of participants with treatment-related adverse events as assessed by safety laboratory measures of haematology and biochemistry.
Changes in laboratory safety parameters as summarised as absolute values of:
Haematology: Haemoglobin, WBC (differentiation of eosinophils and neutrophils), platelets and haematocrit.
Biochemistry: parameters at screening will include: ALT, AST, total bilirubin, creatinine and glucose (random). Troponin sample will be collected before 1st vaccination (at baseline) and stored to be run retrospectively if needed in case of a cardiac event. The sample collected at the time of the cardiac event will be compared with the sample collected at baseline.
Urinalysis performed by dipstick. Proteinuria, glucose and blood.
Measured: Baseline (Day 0 before 1st vaccination) to end of the follow up (Day 168)
MSP1-specific IgG antibody levels assessed by ELISA
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as MSP1-specific IgG antibody levels measured by serum ELISA in sera collected at Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Measured: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Secondary outcomes (4)
Immunogenicity to MSP1-specific IgM antibody levels measured by ELISA
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as MSP1-specific IgM antibody levels measured by serum ELISA in sera collected at Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Measured: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Immunogenicity assessed as antibody-mediated complement fixation activity.
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as antibody-mediated complement fixation activity.
Measured: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Antibody-mediated complement fixation activity
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as antibody-mediated complement fixation activity.
Measured: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Antibody-dependent respiratory burst (ADRB) activity
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as antibody-dependent respiratory burst (ADRB) activity.
Measured: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Mar 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Not enough resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Luxembourg Institute of Health, Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Ally Olotu, MD, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124156
- Sponsor's protocol ID
- EVI-CT-002
- Acronym
- CHMI-SUM-101
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase Ib Trial to Assess the Blood-stage Efficacy of SUM-101 Malaria Vaccine in Adults Residing in Malaria-endemic Settings, After Controlled Human Malaria Infection Using 3D7 P. Falciparum Blood-stage Malaria Infection
- ClinicalTrials.gov ID
- NCT07124156
- Acronym / sponsor ID
- CHMI-SUM-101 / EVI-CT-002
- Conditions
- Malaria Fever
- Keywords
- SUM-01, CHMI, Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- Luxembourg Institute of Health, Ifakara Health Institute
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Full-length MSP1/GLA-SE (SUM-101) malaria vaccine (formerly SumayaVac-1) has been developed by Sumaya Biotech, a spin-off from Heidelberg University, Germany. SUM-101 is a vaccine based on the 3D7 strain (D-form) of full-length merozoite surface protein 1 (full-length MSP1). The full-length MSP1 is expressed as a recombinant heterodimeric protein in E. coli and lyophilised at 150 μg/vial. The lyophilised MSP1 protein is stored at 2 - 8°C. The adjuvant, GLA-SE, was developed by Access to Advanced Health Institute (AAHI), a Washington non-profit corporation with offices at 1616 Eastlake Ave. E, Suite 400, Seattle, WA 98102, USA. It is a stable oil-in-water emulsion containing a synthetic analogue of bacterial glucopyranosyl lipid A and functions as a toll-like receptor 4 agonist. A vial of the adjuvant contains 20μg of GLA-SE in a 400μl emulsion. GLA-SE adjuvant and emulsion formulations should be stored at 2 - 8°C.
The vaccine (SUM-101) is prepared before administration by reconstituting the lyophilised protein in saline (aqueous 0.9% NaCl) and then combining it with the GLA-SE adjuvant. The formulated vaccine is stable at room temperature for up to 60 minutes and administered intramuscularly.
A Phase I first-in-human, double-blinded, randomised trial (PMC6994672) was conducted to assess the safety and immunogenicity of SUM-101 in healthy malaria-naïve adult volunteers in Heidelberg, Germany. The trial demonstrated that SUM-101 is safe, with no serious adverse events (SAE) reported. Vaccination with SUM-101 induced MSP1 specific IgG and IgM antibodies that activated Fc-mediated effector mechanisms and were equally reactive against the vaccine variant (MSP1D/3D7) and a heterologous variant of MSP1 (MSP1F/FCB1). In addition, a Phase Ib trial was conducted in Bagamoyo, Tanzania (NCT05644067, data not yet published) where 20 healthy Tanzanian adults were vaccinated with SUM-101. Preliminary results indicate that SUM-101 is safe and well-tolerated in healthy African adults living in malaria-endemic areas, with ongoing assessments of antibody responses.
Concurrently with this trial, a Phase Ib, randomised, controlled age de-escalation, dose-finding study to evaluate the safety, reactogenicity and immunogenicity of full-length MSP1/GLA-SE (SUM-101) malaria vaccine in healthy young children, and infants (NCT06618885) will be conducted in Burkina Faso. The protocol has been submitted for ethical and regulatory approval in Burkina Faso.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three dose SUM-101 | Experimental | Biological: SUM-101, Other: CHMITwelve participants will receive three monthly inoculations (on D0, D28 and D56) with the IMP, SUM-101. |
| Three dose Verorab | Active comparator | Other: CHMI, Biological: Verorab®12 participants will receive three monthly inoculations (on D0, D28 and D56) with the IMP Verorab® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Written informed consent obtained before any study procedure.
- Literate participants aged ≥18 - ≤45 years of African origin.
- Female and male participants willing to practice effective contraception from 4 weeks before 1st vaccination (female participants only) and up to 12 weeks after the last vaccination or CHMI (female and male participants)
- Female participants must be willing to undergo multiple serum pregnancy tests.
- Available to participate in follow-up for the duration of the study, including the CHMI in-patient confinement period.
Key exclusion criteria (21 listed)
- Previous participation in any malaria vaccine trial in the last 3 years.
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
- Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
- Previous vaccination with a rabies vaccine.
- High anti-schizont antibody level as measured by ELISA at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUM-101Once 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. | Biological | Three dose SUM-101 |
| CHMIExperimental 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 | Other | Three dose SUM-101, Three dose Verorab |
| 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. | Biological | Three dose Verorab |
Primary outcome
Efficacy- Time to diagnosis
Time frame: From Day 84 to Day 168
Blood-stage efficacy of the SUM-101 vaccine against 3D7 clone parasites in a CHMI model in healthy malaria-exposed adult volunteers, measured as time to diagnosis in the vaccine arm compared to controls. Time to diagnosis is defined as the number of days from challenge to treatment
Frequency of local and systemic solicited adverse events
Time frame: After each vaccination (done on Day 0, Day 28 and Day 56) up to 7 days post-vaccination
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by the frequency of local and systemic solicited adverse events (AEs)
Frequency of local and systemic unsolicited adverse events
Time frame: After each vaccination (done on Day 0, Day 28 and Day 56) up to 28 days post-vaccination
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by the frequency of local and systemic unsolicited adverse events
Frequency of any serious adverse events (SAE)
Time frame: Baseline (Day 0 before 1st vaccination) to end of the follow up (Day 168)
Safety of SUM-101 vaccine in healthy malaria-exposed adults as assessed by any serious adverse events (SAE)
Number of participants with treatment-related adverse events as assessed by safety laboratory measures of haematology and biochemistry.
Time frame: Baseline (Day 0 before 1st vaccination) to end of the follow up (Day 168)
Number of participants with treatment-related adverse events as assessed by safety laboratory measures of haematology and biochemistry. Changes in laboratory safety parameters as summarised as absolute values of: Haematology: Haemoglobin, WBC (differentiation of eosinophils and neutrophils), platelets and haematocrit. Biochemistry: parameters at screening will include: ALT, AST, total bilirubin, creatinine and glucose (random). Troponin sample will be collected before 1st vaccination (at baseline) and stored to be run retrospectively if needed in case of a cardiac event. The sample collected at the time of the cardiac event will be compared with the sample collected at baseline. Urinalysis performed by dipstick. Proteinuria, glucose and blood.
MSP1-specific IgG antibody levels assessed by ELISA
Time frame: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Humoral immunogenicity of SUM-101 in malaria-exposed adults assessed as MSP1-specific IgG antibody levels measured by serum ELISA in sera collected at Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
4 secondary outcomes
Immunogenicity to MSP1-specific IgM antibody levels measured by ELISA
Time frame: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI).
Immunogenicity assessed as antibody-mediated complement fixation activity.
Time frame: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Antibody-mediated complement fixation activity
Time frame: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Antibody-dependent respiratory burst (ADRB) activity
Time frame: Day 0 (pre-vaccination) and Day 84 (Pre-CHMI)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ally Olotu, MD principal investigator
Ifakara Health Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUM-101, CHMI and Verorab® in people with Malaria Fever, run by European Vaccine Initiative.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy- Time to diagnosis (time frame: From Day 84 to Day 168). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.