Adults 18 to 45, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of the RH5.1/AS01 Vaccine by Demonstrating a Reduced PMR in Vaccinated Subjects Compared to Infectivity Controls Against 3D7 Clone Parasites in a CHMI Model.Primary· Measured during CHMI
PCR-derived parasite multiplication rate (PMR) will be the primary efficacy endpoint for the Phase IIa stage of the trial, and comparison of the endpoint between the Groups 5 and 6 will constitute the primary analysis for efficacy.
Group
Value
95% CI
Group 5-Phase IIa
8.12
± 1.13
Group 6-Phase IIa
9.75
± 2.46
Group 7-Phase IIa
7.62
± 1.44
Group 9 -Phase IIa
11.22
± 1.92
Safety of RH5.1/AS01 in Healthy Malaria-naïve Adults in the UK.Primary· 8 months
Solicited and unsolicited adverse events collected passively and actively for 28 days post each vaccination.
Number of volunteers reporting any unsolicited AEs post-any vaccination, as reported to investigators or in electronic diaries.
Group
Value
95% CI
Group 1-Phase Ia
9
Group 2- Phase Ia
11
Group 3-Phase Ia
9
Group 4-Phase Ia
10
Group 5-Phase IIa
14
Group 7-Phase IIa
3
the in Vitro Growth Inhibition Activity (GIA) Against 3D7 Clone P. Falciparum Parasites of IgG Purified From the Serum of Vaccinees.Primary· 2 weeks post final vaccination
The specific endpoints for GIA in vitro will be assessed from a titration of the purified IgG in the assay.
Group
Value
95% CI
Group 1-Phase Ia
75.2
± 20.25
Group 2- Phase Ia
69.9
± 11.65
Group 3-Phase Ia
71.3
± 13.76
Group 4-Phase Ia
71.6
± 13.18
the Humoral Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.Secondary· 2 weeks post final vaccination
Antibody responses to the RH5.1 protein generated by vaccination
Group
Value
95% CI
Group 1-Phase Ia
86.9
± 51.75
Group 2- Phase Ia
88.1
± 40.11
Group 3-Phase Ia
124.4
± 81.62
Group 4-Phase Ia
95.6
± 56.07
the Cellular Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.Secondary· 2 weeks post final vaccination
T cell responses to the RH5.1 protein generated by vaccination
Group
Value
95% CI
Group 1-Phase Ia
570
± 439.4
Group 2- Phase Ia
140.7
± 343.9
Group 3-Phase Ia
277.3
± 328.4
Group 4-Phase Ia
713.3
± 396.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Data on solicted adverse events were collected for 7 days after vaccinated and unsolicited adverse events for 28 days post-vaccination. Data on serious adverse events and adverse events of special interest were collected for the study duration. Study duration was 240 days post first vaccination in groups 1, 2 and 4, 366 days post first vaccination in group 3 and 90 days post challenge in groups 5 and 7.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18 and 45 years.
Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and at the CCVTM, Oxford and Guys and St Thomas' NIHR CRF, London for the Phase IIa stage.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
· recruiting
NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
· Phase 2
· recruiting
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI
· Phase 1
· active not recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants
· Phase 1
· recruiting
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha
· Phase 1
· recruiting
Other University of Oxford trials
Trials by the same sponsor.
NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )
· Phase 2
· not yet recruiting
NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults
· Phase 1
· not yet recruiting
NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis
· not yet recruiting
NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE
· Phase 3
· not yet recruiting
NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oxford
Last refreshed: 18 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02927145.