Malaria,FalciparumPhase 1SUM-101NCT06618885
Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso
A Phase 1 study testing SUM-101 in people with Malaria,Falciparum, run by European Vaccine Initiative at 1 site in Burkina Faso.
Trial summary
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine. Read more about this study
- Who is it for?
- Ages 5 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- SUM-101
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 1 Aug 2025to 25 Apr 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 5 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resident in the study area villages and participant's parent(s)/legal guardian anticipate being available for vaccination and follow-up for following last dose of vaccination.
- Z-score of weight-for-age within ±2SD.
Who cannot join
- Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, major congenital defects, malnutrition requiring hospital admission and anaemia.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.
- Clinically significant laboratory abnormality as judged by the study investigator.
- History of blood transfusion.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Previous vaccination with experimental malaria vaccines.
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- Participation in another research study/clinical trial involving receipt of an investigational medicinal product or planned use during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection (no HIV testing); asplenia; recurrent, severe infections and chronic immunosuppressant medication (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant´s ability to participate in the trial.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Groupe de Recherche Action en Santé (GRAS)
Ouagadougou, 06 BP 10248
About this study
Official title: A Phase 1b, 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 in Burkina Faso.
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine. This will be the first time SUM-101 will be evaluated for safety and immunogenicity in infants and children. The main questions it aims to answer are:
- Are the 3 doses of full-length MSP1/GLA-SE (SUM-101) in young children and infants safe?
- Do the 3 doses of full-length MSP1/GLA-SE (SUM-101) in young children and infants produce any reactogenicity?
- How is the immunogenicity in young children and infants generated by the 3 doses of full-length MSP1/GLA-SE (SUM-101)?
- What is the optimal dose of the full-length MSP1/GLA-SE (SUM-101) in young children and infants? The study will be divided into two arms with 5 groups conducted at a single centre. In total, 39 healthy malaria-pre-exposed infants and children aged 5 months to 5 years will be enrolled in this study.
Read more
Participants will be included in one of the following groups:
- Arm 1_Group 1 (open-label design): This will be the first cohort enrolled to assess safety in children (18 months - 5 years) before the vaccination of infants commences. Therefore, all participants in Arm 1 will receive one dose of SUM-101 vaccine (25µg MSP1 + 2µg GLA-SE) on D0, D28 and D56.
- Arm 2_Group 2-3 (randomised, controlled, double-blind design): This will be the second cohort enrolled to assess safety in the target population (infants aged 5-17 months). Infants will be assigned to Groups 2-3 to enable evaluation of one dose of MSP1 (10µg) and two doses of GLA-SE (2µg and 1µg). The infants in each group will be randomised into A) a vaccine arm (12 participants) and B) a control arm (3 participants). All participants in Groups 2-3 will receive one doses of SUM-101 vaccine or Verorab® (Rabies vaccine) on D0, D28 and D56.
Participants will visit the clinic for screening and once selected for enrolment. No later than 28 days after selection participants will receive the 1st vaccination (Visit Day 0) and 2nd and 3rd Vaccination on Day 28 and Day 56. On Day 1 to 6 days post each vaccination (Day 1-6, Day 29-34 and Day 57-62) each participant will be visited at home daily by a field worker for assessment and recording of any solicited and unsolicited AEs (Reactogenicity visits).
Read the detailed description
Experimental design: Phase Ib, age de-escalation and dose-escalation study. A total of 39 participants will be enrolled, consisting of healthy children (18 months-5 years) and infants (5-17 months) residing in Sabou health district or in Banfora health district, Burkina Faso. The participants will be divided into three groups. Two doses of MSP1 (25μg and 10μg) and two doses of GLA-SE (2μg and 1μg) will be evaluated.
Group 1 will be the first cohort enrolled to assess safety in children before the vaccination of infants commences. There will be no control arm, therefore, all participants in Group 1 will receive three doses of SUM-101 vaccine on D0, D28 and D56 in an open-label design.
Groups 2 and 3 will consist of the target population (infants aged 5-17 months) who will be randomised into A) a vaccine arm (12 participants) and B) a control arm (3 participants). Vaccination of Groups 2 and 3 will be conducted in a double-blinded manner. All participants in Groups 2 and 3 will receive three doses of either SUM-101 vaccine or Verorab® (rabies vaccine) on D0, D28 and D56.
Because this is the first time SUM-101 is administered to children and infants, the vaccinations will be staggered with regular safety reviews. A dose of 25μg MSP1+2μg GLA-SE will be used in children in Group 1. This choice is based on the good safety and tolerability data obtained in malaria naïve adults in Germany using this dose. Subject to favourable safety data from children, a lower dose of 10μg MSP1 with 1μg or 2μg of GLA-SE will be used in infants in Groups 2A and 3A. As an additional safety measure, the first 3 participants enrolled in Group 1 will be sentinels who will be vaccinated in an open-label manner. To ensure blinding, the first 4 participants enrolled in Groups 2 and 3 will be sentinels who will be vaccinated with either SUM-101 or control vaccine. The sentinel participants will be vaccinated one at a time (not at the same time) at least 72 hours before the remaining participants are vaccinated.
For the children cohort, the trial will be an open-label uncontrolled trial (with no control group), as the cohort of children will be used as a transition group between adults and infants. Tolerance and safety in adults have already been demonstrated in previous trials in Germany and Tanzania. The safety of the lowest dose used in adults will be evaluated in children in an open-label manner (without a control group, in a staggered fashion with a sentinel approach and a review of the data by the Data Safety Monitoring Board -DSMB-) to ensure a safe transition to the target group of the study, the infant population, where the vaccine will also be administered in a staggered fashion with a sentinel approach. Adjuvant doses are informed by safety and immunogenicity data from previous SUM-101 clinical trials and as recommended by the adjuvant manufacturer and another clinical trial (NCT04607408).
The principal investigator (PI) will review the safety data of the sentinel participants and decide whether to proceed with the vaccination of the other participants according to pre-defined safety criteria. In case of any product-related safety concerns, the decision will be made by the DSMB. The DSMB will review safety data and decide whether to transition from vaccination of children (Group 1) to infants (Group 2 and 3). Additional DSMB meetings will be scheduled at the end of the follow up period.
The duration of involvement in the study from enrolment will be approximately 24 weeks. The screening period will be approximately 4 weeks. The vaccination phase of the study takes 8 weeks for each participant, and the post-vaccination follow-up lasts for up to 12 weeks after the third vaccination.
- Conditions
- Malaria,Falciparum
- Being tested
- SUM-101
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUM-101Biological
Three immunizations every 4 weeks for 3 months (total 3 immunizations)
| Study group | Role | What they receive |
|---|---|---|
| Children (18 months - 5 years) | Experimental | Children (18 months - 5 years) will not be randomised. The first 3 participants will be enrolled as sentinel participants prior to the 6 follower participants. The nine participants of Group 1 will receive three administrations of the SUM-101 vaccine (25µg MSP1 + 5µg GLA-SE) in an open-label design. Receives: Biological: SUM-101 |
| Infants (5-17 months) | Experimental | For safety reasons, vaccination of infants will be staggered based on the dosage of MSP1 and the GLA-SE adjuvant used. The following dosages will be evaluated:
* Group 2: 10µg MSP1 + 2.5µg GLA-SE
* Group 3: 10µg MSP1 + 5µg GLA-SE
* Group 4: 25µg MSP1 + 2.5µg GLA-SE
* Group 5: 25µg MSP1 + 5µg GLA-SE Enrollment and vaccination of infants will start with Groups 2 and 3, and only proceed to Groups 4 and 5 if there are no safety concerns. The first infants enrolled into each group will be sentinels (4 per group). The At least tThree out four sentinels will receive the SUM-101 vaccine dose assigned to their respective groups. The participants enrolled into Groups 2-5 (both sentinels and followers) will be randomised at a ratio of 4:1 into vaccine and control arms. In total, 12 participants per group will receive the SUM-101 vaccine (either 25µg or 10µg of MSP1 and either 5µg or 2.5µg of GLA-SE) and 3 participants will receive the control vaccine (rabies vaccine, Verorab®). Receives: Biological: SUM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic solicited adverse events (AEs) at least possibly related to the SUM-101.
Local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) SUM-101 will be recorded to evaluate safety and reactogenicity.
Measured: After each vaccination (done on Day0, Day28 and Day56) up to 7 days after.
Local and systemic unsolicited reactogenicity adverse events (AEs).
Local and systemic unsolicited reactogenicity will be recorded to evaluate the safety and reactogenicity of SUM-101.
Measured: Recorder after each vaccination (done on Day0, Day28 and Day56) up to 28 days later.
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 (RBC count, WBC count with differentials (neutrophil, lymphocyte and eosinophil), Haemoglobin (Hgb), Haematocrit and platelet count.
Biochemistry-, Serum creatinine, Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST) and Total bilirubin.
Measured: Between baseline (Day 0 before 1st vaccination) to 28 days after each vaccination.
Any serious adverse events (SAE) occurring during the whole study duration.
Any serious adverse events (SAE) occurring after signature of the informed consent until the participant's last visit to evaluate the safety and reactogenicity of SUM-101.
Measured: Recorded after signature of informed consent until the participant's last visit (Day 140)
Secondary outcomes (3)
IgG antibody titres against full-length MSP1
IgG antibody titters against the full-length MSP1 will be measured by ELISA.
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit).
Identification of the dose of full-length MSP1/GLA-SE (SUM-101) in young children and infants that give the safety profile.
Comparison of local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) SUM-101 will be recorded to evaluate safety and reactogenicity across different doses of full-length MSP1 and GLA-SE in infants and young children .
Measured: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Identification of the dose of full-length MSP1/GLA-SE (SUM-101) in young children and infants that give the strongest immune response.
Comparison of IgG antibody titters against the full-length MSP1 will be measured by ELISA across different doses of full-length MSP1 and GLA-SE in infants and young children.
Measured: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Aug 2025
- Primary completion31 Jan 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe de Recherche Action en Sante, Luxembourg Institute of Health
- Responsible party
- Sponsor
- Investigators
- Sodiomon Sirima, MD, Principal investigator, Groupe de Recherche Action en Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618885
- Sponsor's protocol ID
- EVI-CT-001
- Acronym
- SUM-101
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2024
- 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 Phase 1b, 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 in Burkina Faso.
- ClinicalTrials.gov ID
- NCT06618885
- Acronym / sponsor ID
- SUM-101 / EVI-CT-001
- Conditions
- Malaria,Falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- Groupe de Recherche Action en Sante, Luxembourg Institute of Health
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 1 Oct 2024 (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.
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine. This will be the first time SUM-101 will be evaluated for safety and immunogenicity in infants and children. The main questions it aims to answer are:
- Are the 3 doses of full-length MSP1/GLA-SE (SUM-101) in young children and infants safe?
- Do the 3 doses of full-length MSP1/GLA-SE (SUM-101) in young children and infants produce any reactogenicity?
- How is the immunogenicity in young children and infants generated by the 3 doses of full-length MSP1/GLA-SE (SUM-101)?
- What is the optimal dose of the full-length MSP1/GLA-SE (SUM-101) in young children and infants? The study will be divided into two arms with 5 groups conducted at a single centre. In total, 39 healthy malaria-pre-exposed infants and children aged 5 months to 5 years will be enrolled in this study.
Participants will be included in one of the following groups:
- Arm 1_Group 1 (open-label design): This will be the first cohort enrolled to assess safety in children (18 months - 5 years) before the vaccination of infants commences. Therefore, all participants in Arm 1 will receive one dose of SUM-101 vaccine (25µg MSP1 + 2µg GLA-SE) on D0, D28 and D56.
- Arm 2_Group 2-3 (randomised, controlled, double-blind design): This will be the second cohort enrolled to assess safety in the target population (infants aged 5-17 months). Infants will be assigned to Groups 2-3 to enable evaluation of one dose of MSP1 (10µg) and two doses of GLA-SE (2µg and 1µg). The infants in each group will be randomised into A) a vaccine arm (12 participants) and B) a control arm (3 participants). All participants in Groups 2-3 will receive one doses of SUM-101 vaccine or Verorab® (Rabies vaccine) on D0, D28 and D56.
Participants will visit the clinic for screening and once selected for enrolment. No later than 28 days after selection participants will receive the 1st vaccination (Visit Day 0) and 2nd and 3rd Vaccination on Day 28 and Day 56. On Day 1 to 6 days post each vaccination (Day 1-6, Day 29-34 and Day 57-62) each participant will be visited at home daily by a field worker for assessment and recording of any solicited and unsolicited AEs (Reactogenicity visits).
Detailed description
Experimental design: Phase Ib, age de-escalation and dose-escalation study. A total of 39 participants will be enrolled, consisting of healthy children (18 months-5 years) and infants (5-17 months) residing in Sabou health district or in Banfora health district, Burkina Faso. The participants will be divided into three groups. Two doses of MSP1 (25μg and 10μg) and two doses of GLA-SE (2μg and 1μg) will be evaluated.
Group 1 will be the first cohort enrolled to assess safety in children before the vaccination of infants commences. There will be no control arm, therefore, all participants in Group 1 will receive three doses of SUM-101 vaccine on D0, D28 and D56 in an open-label design.
Groups 2 and 3 will consist of the target population (infants aged 5-17 months) who will be randomised into A) a vaccine arm (12 participants) and B) a control arm (3 participants). Vaccination of Groups 2 and 3 will be conducted in a double-blinded manner. All participants in Groups 2 and 3 will receive three doses of either SUM-101 vaccine or Verorab® (rabies vaccine) on D0, D28 and D56.
Because this is the first time SUM-101 is administered to children and infants, the vaccinations will be staggered with regular safety reviews. A dose of 25μg MSP1+2μg GLA-SE will be used in children in Group 1. This choice is based on the good safety and tolerability data obtained in malaria naïve adults in Germany using this dose. Subject to favourable safety data from children, a lower dose of 10μg MSP1 with 1μg or 2μg of GLA-SE will be used in infants in Groups 2A and 3A. As an additional safety measure, the first 3 participants enrolled in Group 1 will be sentinels who will be vaccinated in an open-label manner. To ensure blinding, the first 4 participants enrolled in Groups 2 and 3 will be sentinels who will be vaccinated with either SUM-101 or control vaccine. The sentinel participants will be vaccinated one at a time (not at the same time) at least 72 hours before the remaining participants are vaccinated.
For the children cohort, the trial will be an open-label uncontrolled trial (with no control group), as the cohort of children will be used as a transition group between adults and infants. Tolerance and safety in adults have already been demonstrated in previous trials in Germany and Tanzania. The safety of the lowest dose used in adults will be evaluated in children in an open-label manner (without a control group, in a staggered fashion with a sentinel approach and a review of the data by the Data Safety Monitoring Board -DSMB-) to ensure a safe transition to the target group of the study, the infant population, where the vaccine will also be administered in a staggered fashion with a sentinel approach. Adjuvant doses are informed by safety and immunogenicity data from previous SUM-101 clinical trials and as recommended by the adjuvant manufacturer and another clinical trial (NCT04607408).
The principal investigator (PI) will review the safety data of the sentinel participants and decide whether to proceed with the vaccination of the other participants according to pre-defined safety criteria. In case of any product-related safety concerns, the decision will be made by the DSMB. The DSMB will review safety data and decide whether to transition from vaccination of children (Group 1) to infants (Group 2 and 3). Additional DSMB meetings will be scheduled at the end of the follow up period.
The duration of involvement in the study from enrolment will be approximately 24 weeks. The screening period will be approximately 4 weeks. The vaccination phase of the study takes 8 weeks for each participant, and the post-vaccination follow-up lasts for up to 12 weeks after the third vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children (18 months - 5 years) | Experimental | Biological: SUM-101Children (18 months - 5 years) will not be randomised. The first 3 participants will be enrolled as sentinel participants prior to the 6 follower participants. The nine participants of Group 1 will receive three administrations of the SUM-101 vaccine (25µg MSP1 + 5µg GLA-SE) in an open-label design. |
| Infants (5-17 months) | Experimental | Biological: SUM-101For safety reasons, vaccination of infants will be staggered based on the dosage of MSP1 and the GLA-SE adjuvant used. The following dosages will be evaluated: * Group 2: 10µg MSP1 + 2.5µg GLA-SE * Group 3: 10µg MSP1 + 5µg GLA-SE * Group 4: 25µg MSP1 + 2.5µg GLA-SE * Group 5: 25µg MSP1 + 5µg GLA-SE Enrollment and vaccination of infants will start with Groups 2 and 3, and only proceed to Groups 4 and 5 if there are no safety concerns. The first infants enrolled into each group will be sentinels (4 per group). The At least tThree out four sentinels will receive the SUM-101 vaccine dose assigned to their respective groups. The participants enrolled into Groups 2-5 (both sentinels and followers) will be randomised at a ratio of 4:1 into vaccine and control arms. In total, 12 participants per group will receive the SUM-101 vaccine (either 25µg or 10µg of MSP1 and either 5µg or 2.5µg of GLA-SE) and 3 participants will receive the control vaccine (rabies vaccine, Verorab®). |
Who may qualify
- Ages
- 5 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Resident in the study area villages and participant's parent(s)/legal guardian anticipate being available for vaccination and follow-up for following last dose of vaccination.
- Z-score of weight-for-age within ±2SD.
Key exclusion criteria (9 listed)
- Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, major congenital defects, malnutrition requiring hospital admission and anaemia.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.
- Clinically significant laboratory abnormality as judged by the study investigator.
- History of blood transfusion.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
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-101Three immunizations every 4 weeks for 3 months (total 3 immunizations) | Biological | Children (18 months - 5 years), Infants (5-17 months) |
Primary outcome
Local and systemic solicited adverse events (AEs) at least possibly related to the SUM-101.
Time frame: After each vaccination (done on Day0, Day28 and Day56) up to 7 days after.
Local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) SUM-101 will be recorded to evaluate safety and reactogenicity.
Local and systemic unsolicited reactogenicity adverse events (AEs).
Time frame: Recorder after each vaccination (done on Day0, Day28 and Day56) up to 28 days later.
Local and systemic unsolicited reactogenicity will be recorded to evaluate the safety and reactogenicity of SUM-101.
Number of participants with treatment-related adverse events as assessed by safety laboratory measures of haematology and biochemistry.
Time frame: Between baseline (Day 0 before 1st vaccination) to 28 days after each vaccination.
Changes in laboratory safety parameters as summarised as absolute values of: Haematology (RBC count, WBC count with differentials (neutrophil, lymphocyte and eosinophil), Haemoglobin (Hgb), Haematocrit and platelet count. Biochemistry-, Serum creatinine, Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST) and Total bilirubin.
Any serious adverse events (SAE) occurring during the whole study duration.
Time frame: Recorded after signature of informed consent until the participant's last visit (Day 140)
Any serious adverse events (SAE) occurring after signature of the informed consent until the participant's last visit to evaluate the safety and reactogenicity of SUM-101.
3 secondary outcomes
IgG antibody titres against full-length MSP1
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit).
Identification of the dose of full-length MSP1/GLA-SE (SUM-101) in young children and infants that give the safety profile.
Time frame: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Identification of the dose of full-length MSP1/GLA-SE (SUM-101) in young children and infants that give the strongest immune response.
Time frame: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Sodiomon Sirima, MD principal investigator
Groupe de Recherche Action en Sante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUM-101 in people with Malaria,Falciparum, run by European Vaccine Initiative at 1 site in Burkina Faso.
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 2 inclusion and 9 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: finished, 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.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local and systemic solicited adverse events (AEs) at least possibly related to the SUM-101. (time frame: After each vaccination (done on Day0, Day28 and Day56) up to 7 days after.). The study lists 4 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.