A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

NCT05790889 | Recruiting Phase 1 DMC

• 1 other identifier: VAC091
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso

Conditions

Malaria,Falciparum

Outcome Measures

Primary Outcomes (2)

• To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination.

  Time to first episode of clinical malaria (defined as the presence of axillary temperature higher than 37.5 degree celsius and P. Falciparum parasite density \>5000 asexual forms/µL)

  From 14 days after the third study vaccination until 6 months after the third study vaccination.

• To assess the safety and reactogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.

  Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits

  The month following each vaccination and at 6 and 12 months after administration of the final dose of vaccine.

Secondary Outcomes (8)

• To assess the humoral immunogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.

  Immunology blood samples will be collected at screening, day of vaccination (V) 1, 14 & 28 days post V2, day of V3, 14 days post V3, 2, 6 and 12 months post V3.

• To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 3 months after the last vaccination.

  From 14 days after the third study vaccination until 3 months after the third study vaccination

• To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area

  For 12 months after the last vaccination

• To assess the protective efficacy against asymptomatic P. falciparum infection of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.

  At 6 and 12 months after administration of the final dose of vaccine.

• To assess the protective efficacy against asymptomatic P. falciparum infection against gametocytaemia of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.

  At 6 and 12 months post third study vaccination.

Study Arms (5)

Group 1 (Control group)

PLACEBO COMPARATOR

n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 152.

Biological: Rabies vaccine

Group 2

EXPERIMENTAL

n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 152.

Biological: RH5.1 10μg adjuvated with 50μg Matrix-M

Group 3 (Control Group)

PLACEBO COMPARATOR

n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 56.

Biological: Rabies vaccine

Group 4

EXPERIMENTAL

n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.

Biological: RH5.1 10μg adjuvated with 50μg Matrix-M

Group 5

EXPERIMENTAL

n=120 Age= 5-17 months First vaccination of RH5.2-VLP 5μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.

Biological: RH5.2 5μg adjuvated with 50μg Matrix-M

Interventions

Rabies vaccine BIOLOGICAL

Vaccine

Group 1 (Control group); Group 3 (Control Group)

RH5.1 10μg adjuvated with 50μg Matrix-M BIOLOGICAL

Vaccine

Group 2; Group 4

RH5.2 5μg adjuvated with 50μg Matrix-M BIOLOGICAL

Vaccine

Group 5

Eligibility Criteria

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

You may qualify if:

• Healthy infant aged 5-17 months at the time of first study vaccination
• Parent/guardian provides signed/thumb-printed informed consent
• Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.

You may not qualify if:

• Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
• Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
• Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
• History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Sickle cell disease.
• Clinically significant laboratory abnormality as judged by the study clinician.
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
• Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.
• History of vaccination with another malaria vaccine.
• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
• Known maternal HIV infection (no testing will be done by the study team).
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (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

• University of Oxford: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Institut de Recherche en Sciences de la Santé

Siglé, Boulkiemdé Province, BP 7192 OUAGADOUGOU 03, BF, Burkina Faso

RECRUITING

Related Publications (1)

• Natama HM, Salkeld J, Some A, Soremekun S, Diallo S, Traore O, Rouamba T, Ouedraogo F, Ouedraogo E, Dabone KCS, Kone NA, Compaore ZMJ, Kafando M, Bonko MDA, Konate F, Sorgho H, Nielsen CM, Pipini D, Diouf A, King LDW, Shaligram U, Long CA, Cho JS, Lawrie AM, Skinner K, Roberts R, Miura K, Bradley J, Silk SE, Draper SJ, Tinto H, Minassian AM. Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. Lancet Infect Dis. 2025 May;25(5):495-506. doi: 10.1016/S1473-3099(24)00752-7. Epub 2024 Dec 10.

  PMID: 39672183 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Rabies Vaccines; Matrix-M

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Angela Minassian

  Honorary Consultant and Chief Investigator - Project clinical trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee-Sun Cho

CONTACT

+44 (0)1865 611418; vaccinetrials@ndm.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 30, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

BU (1)