At a glance
ClinicalIndex Comparison Record- ✓Healthy adults aged 18 to 45 years
- ✓Able and willing to comply with all study requirements
- ✓For Groups 5-6: willingness to take curative anti-malaria regimen following CHMI
- ✓For Groups 5-6: reachable 24 hours/day by mobile phone during CHMI to antimalarial treatment completion
- ✕Prior receipt of investigational malaria vaccine or other investigational vaccine likely to impact trial interpretation
- ✕History of malaria (any species)
- ✕Travel to malaria endemic region during study or within previous 6 months
- ✕Any immunosuppressive or immunodeficient state, including HIV infection, asplenia, or chronic immunosuppressant medication (>14 days) in prior 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/IIa Clinical Trial to Assess the Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Falciparum Malaria Vaccine Candidate RH5.1/AS01
In Brief
A Phase 2 clinical trial evaluating RH5.1/ ASO1 for Malaria. Completed, enrolled 88 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum. The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity.