RH5.2-VLP / University of Oxford - LARVOL DELTA

Characterisation of the immune responses induced by the blood-stage vaccine candidate RH5.2/Matrix-M® alone and in combination with the licensed pre-erythrocytic vaccine R21/Matrix-M®. (ASTMH 2025) - P1 | "Here in a Phase Ib (NCT05357560) clinical trial, administering RH5.2-VLP alone and in combination with R21 formulated in MM in Gambian adults and children, as a multi-stage malaria vaccine candidate, we report vaccine immunogenicity, assessing antibody magnitude over time as well as functional GIA. Antibodies to blood-stage component of this study were assessed against both full-length RH5 immunogen (RH5.1) and RH5.2 vaccine immunogen to allow correlation with GIA outcome. This is the first opportunity for analysis of humoral immunogenicity of an RH5-based vaccine in the context of a multi-stage regimen, and for comparison between second generation RH5.2 and previously reported data with the more advanced RH5.1/MM candidate, critical for blood-stage vaccine candidate down selection and multi-stage vaccine development."

Combination therapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Malaria

A Phase Ib trial to assess the safety and tolerability of the blood-stage malaria vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-M™ and the pre-erythrocytic stage vaccine R21 in Matrix-M™, both alone and in combination, in adults . (ASTMH 2025) - "Current WHO-approved malaria vaccines are only effective against the pre-erythrocytic stage of malaria. RH5.2-VLP/Matrix-M™, given alone or combined with R21, had a favorable safety profile and was well tolerated. These results pave the way for further studies to assess vaccine immunogenicity."

Clinical • P1 data • Anorexia • Fatigue • Infectious Disease • Malaria • Respiratory Diseases

A Phase 1a clinical trial of the safety and immunogenicity of RH5.2-VLP with Matrix-M®in UK adults - a novel blood-stage P. falciparum malaria vaccine candidate (ASTMH 2025) - "Primary immunogenicity outcome measures, including anti-RH5 IgG responses and functional activity as assessed by the growth inhibition activity (GIA) assay, are being assessed and the data will be presented. Following on from this trial, a Phase 1b trial of RH5.2-VLP/MM alone and in combination with R21/MM (a multi-stage malaria vaccine candidate) is underway in The Gambia."

Clinical • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Malaria • Musculoskeletal Pain

A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21 (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: University of Oxford | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso. (clinicaltrials.gov) - P1/2 | N=480 | Recruiting | Sponsor: University of Oxford | Phase classification: P2b ➔ P1/2 | Trial completion date: Aug 2024 ➔ May 2026 | Trial primary completion date: Aug 2024 ➔ May 2026

Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines (clinicaltrials.gov) - P1/2 | N=58 | Active, not recruiting | Sponsor: University of Oxford | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Malaria • G6PD

Preclinical development of a stabilized RH5 virus-like particle vaccine that induces improved antimalarial antibodies. (PubMed, Cell Rep Med) - "These studies identify a blood-stage malaria vaccine candidate that may improve upon the current leading soluble protein vaccine candidate RH5.1/Matrix-M. The RH5.2-VLP/Matrix-M vaccine candidate is now under evaluation in phase 1a/b clinical trials."

Journal • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Malaria

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso. (clinicaltrials.gov) - P2b | N=480 | Recruiting | Sponsor: University of Oxford | N=720 ➔ 480

Enrollment change • Infectious Disease • Malaria

A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: University of Oxford | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria • G6PD

A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: University of Oxford

New P1/2 trial • Infectious Disease • Malaria • G6PD