Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso

NCT06618885 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: EVI-CT-001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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. 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, 69 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 three doses of SUM-101 vaccine (25µg MSP1 + 5µg GLA-SE) on D0, D28 and D56.
• Arm 2\_Group 2-5 (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 2-5 to enable evaluation of two doses of MSP1 (25µg and 10µg) and two doses of GLA-SE (5µg and 2.5µg). 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 2-5 will receive three doses of either 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).

Conditions

Malaria,Falciparum

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Recorded after signature of informed consent until the participant's last visit (Day 140)

Secondary Outcomes (3)

• IgG antibody titres against full-length MSP1

  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.

  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.

  Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)

Other Outcomes (8)

• Evaluation of antibody-mediated complement fixation activity.

  Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit).

• Evaluation of antibody-dependent respiratory burst (ADRB) activity of vaccine-induced antibodies.

  Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit).

• Age dependency of IgG and IgM antibody titers against full-length MSP1 in comparison to Tanzanian and German adults who previously received SUM-101 vaccine.

  Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit).

Study Arms (2)

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.

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®).

Biological: SUM-101

Interventions

SUM-101 BIOLOGICAL

Three immunizations every 4 weeks for 3 months (total 3 immunizations)

Children (18 months - 5 years); Infants (5-17 months)

Eligibility Criteria

• Age: 5 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• European Vaccine Initiative: lead
• Groupe de Recherche Action en Sante: collaborator
• Luxembourg Institute of Health: collaborator

Study Sites (1)

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, 06 BP 10248, Burkina Faso

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Sodiomon Sirima, MD

  Groupe de Recherche Action en Sante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be conducted in a double-blinded manner. Namely, the participants, site staff, sponsor staff, the study monitor(s) and the trial statistician will be blinded to the treatment allocation. The independent statistician and the pharmacist are not blind throughout the study.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: August 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)