Malaria,Falciparum Clinical Trial
Official title:
A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M. During recruitment to Groups 3, 4 and 5, participants will be randomised 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5). There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from final vaccination. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04130282 -
VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine
|
Phase 1 | |
Completed |
NCT04049916 -
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03814616 -
Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections
|
Phase 2 | |
Active, not recruiting |
NCT04079621 -
Short Course Radical Cure of P. Vivax Malaria in Nepal
|
Phase 4 | |
Completed |
NCT05135273 -
Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali
|
Phase 1 | |
Not yet recruiting |
NCT06083688 -
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
|
Phase 4 | |
Recruiting |
NCT03511443 -
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
|
N/A | |
Completed |
NCT05550909 -
Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali
|
Phase 2 | |
Recruiting |
NCT05306067 -
Plasmodium Falciparum Genomic Intelligence in Mozambique
|
||
Completed |
NCT05081089 -
Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali
|
Phase 2 | |
Recruiting |
NCT05150808 -
Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania
|
Phase 3 | |
Recruiting |
NCT05757167 -
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
|
Phase 4 | |
Completed |
NCT01992900 -
A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria
|
Phase 2 | |
Completed |
NCT04565184 -
Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine for the Treatment of Malaria in Yaounde
|
Phase 4 | |
Completed |
NCT03896724 -
Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso
|
Phase 1/Phase 2 | |
Completed |
NCT03454048 -
Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2
|
N/A | |
Recruiting |
NCT04844905 -
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
|
Phase 3 | |
Completed |
NCT03138096 -
Safety and Protective Efficacy of Pb(PfCS@UIS4)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04271306 -
Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.
|
Phase 1 | |
Recruiting |
NCT05058885 -
Plasmodium Vivax Among Duffy Negative Population in Cameroon.
|