Malaria,Falciparum Clinical Trial
Official title:
A Phase 1b/2b Double Blind, Randomized, Controlled Study of the Safety, Immunogenicity, and Efficacy of Malaria Vaccine Candidate MSP3-CRM-Vac4All/ Alhydrogel® in Young Children in Mali
Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living in highly seasonal malaria areas of Mali
This study is designed to be executed in two steps to achieve the primary efficacy objective: The first step is a Phase 1b safety study, involving injections in a small safety subgroup for each dose before age-de-escalation into the younger age group and then proceeding to the second step of dosing the corresponding injection in the larger Phase 2b efficacy cohort. Vaccination of the Phase 2b cohort will require an acceptable reactogenicity data over the first week following the corresponding vaccination of the older and younger age groups in the Phase 1 subgroup. The study DSMB will be charged with this review and ensuring that vaccination proceeds only if the reactogenicity profile meet study "go" criteria (Table 1). The objectives of each phase are: Phase 1b: The primary objective is to assess the safety and tolerability of the vaccine for each injection. The secondary objective is to evaluate the immune response to the vaccine and safety for up to 12 months after the first dose. Phase 2b: The primary objective is to assess the efficacy in young children* against clinical malaria** during one transmission season. The timeline for the primary analysis assessment is from 14 days to 6 months after Dose 3. Should the primary analysis data demonstrate that the vaccine gives good efficacy, a boost vaccination will be programmed to be administered to willing subjects before the start of the subsequent transmission season. The study protocol will be amended with the precise details in this event. ;
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.
|