A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants
NCT03580824 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2023-08-03
Summary
This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
Conditions
- Malaria,Falciparum
Interventions
- BIOLOGICAL
-
R21 in Matrix- M adjuvant vaccine
R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
Sponsors & Collaborators
-
Kenya Medical Research Institute
collaborator OTHER -
European and Developing Countries Clinical Trials Partnership (EDCTP)
collaborator OTHER_GOV -
University of Oxford
lead OTHER
Principal Investigators
-
Adrian Hill · University of Oxford
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Months
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-30
- Primary Completion
- 2022-06-14
- Completion
- 2022-06-14
Countries
- Kenya
Study Locations
More Related Trials
-
VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules
NCT03970993 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™
NCT06320535 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21
NCT05357560 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali
NCT06080243 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
NCT02600975 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
NCT06958198 ·Status: RECRUITING ·Phase: PHASE1
-
Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines
NCT05155579 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
NCT05790889 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
R21/MM Dosing, Presentations, and Preservatives
NCT07194668 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M
NCT07183371 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M in Healthy UK Adults
NCT05385471 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
NCT00380393 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania
NCT04318002 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV
NCT05385510 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults
NCT03824236 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya
NCT00666380 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
NCT06507605 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Effectiveness of Two New Malaria Vaccines
NCT01003314 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
NCT00317473 ·Status: COMPLETED ·Phase: PHASE1
-
An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
NCT07009847 ·Status: RECRUITING
-
A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines
NCT05978037 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults
NCT05252845 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Finding Trial of R21/Matrix-M in School Children
NCT07074665 ·Status: RECRUITING ·Phase: PHASE2
-
A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2
NCT03203421 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
NCT07036159 ·Status: RECRUITING ·Phase: PHASE2