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

NCT ID: NCT05790889

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2026-05-30

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

Detailed Description

During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M.

During recruitment to Groups 3, 4 and 5, participants will be randomised 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5).

There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from final vaccination.

The trial is funded by EDCTP grant number RIA2016V-1649-MMVC and by a Wellcome Trust Translational Award (205981/Z/17/Z)

Conditions

Malaria,Falciparum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Control group)

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

Group Type: PLACEBO_COMPARATOR

Rabies vaccine

Intervention Type: BIOLOGICAL

Vaccine

Group 2

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Vaccine

Group 3 (Control Group)

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

Group Type: PLACEBO_COMPARATOR

Rabies vaccine

Intervention Type: BIOLOGICAL

Vaccine

Group 4

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Vaccine

Group 5

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Vaccine

Interventions

Rabies vaccine

Vaccine

Intervention Type: BIOLOGICAL

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

Vaccine

Intervention Type: BIOLOGICAL

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

Vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy infant aged 5-17 months at the time of first study vaccination

2. Parent/guardian provides signed/thumb-printed informed consent

3. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherche en Sciences de la Sante, Burkina Faso

OTHER_GOV

Sponsor Role: collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Minassian

Role: PRINCIPAL_INVESTIGATOR

Honorary Consultant and Chief Investigator - Project clinical trials

Locations

Institut de Recherche en Sciences de la Santé

Siglé, Boulkiemdé Province, Burkina Faso

Site Status: RECRUITING

Countries

Burkina Faso

Central Contacts

Jee-Sun Cho

Role: CONTACT

vaccinetrials@ndm.ox.ac.uk

+44 (0)1865 611418

Facility Contacts

Dr Athanase M. Somé, Doctorat en médecine

Role: primary

athanasesome@crun.bf

25446249 ext. +226

References

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.

Reference Type: DERIVED

PMID: 39672183 (View on PubMed)

Other Identifiers

VAC091

Identifier Type: -

Identifier Source: org_study_id