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ACTIVE NOT RECRUITING
NCT07183371
PHASE2

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the malaria vaccine candidates R78C with Matrix-M™, and the combination of RH5.1 and R21 with Matrix-M™, in children aged 5-36 months in Burkina Faso.

Official title: A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Malaria Vaccine Candidates R78C With Matrix-M™, and the Combination of RH5.1 and R21 With Matrix-M™, in Children Aged 5-36 Months in Burkina Faso

Key Details

Gender

All

Age Range

5 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-12-15

Completion Date

2026-12

Last Updated

2026-03-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

R21

A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein

BIOLOGICAL

RH5.1

A soluble protein vaccine against the RH5 antigen

BIOLOGICAL

R78C

A soluble RIPR EGF-CyRPA fusion protein vaccine

BIOLOGICAL

Matrix-M™

A saponin-based vaccine adjuvant

BIOLOGICAL

Rabivax-S

Rabivax-S is an inactivated, freeze-dried, single-dose vaccine. The vaccine contains purified, inactivated rabies antigen produced using Vero ATCC CCL 81 cells as the cell substrate, Pitman Moore (PM3218) as the virus strain, and sucrose, glycine and HSA (Human Serum Albumin) as excipients

BIOLOGICAL

Menveo

Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.

BIOLOGICAL

Avaxim 80

Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).

Locations (1)

Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)

Nanoro, Burkina Faso