A Study to assess the Safety and Immunogenicity of the MAlaria Vaccine, R1, With Matrix-M1 Adjuvant

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2016
INTERVENTION: Normal Saline R21/Matrix‐M1 CONDITION: ; Malaria Malaria PRIMARY OUTCOME: To assess the safety and reactogenicity of three (3) doses of 10 & 50 ¿g of the malaria vaccine candidate R21 adjuvanted with Matrix‐M1, given intramuscularly at 0, 1, 2 months schedule in healthy West African adult volunteers living in a malaria‐endemic area. SECONDARY OUTCOME: To assess the immunogenicity of three (3) doses of 10 & 50 ¿g of the malaria vaccine candidate R21 adjuvanted with Matrix‐M1, given intramuscularly at 0, 1, 2 months schedule in healthy West African adult volunteers living in a malaria‐endemic area. INCLUSION CRITERIA: The volunteer must satisfy all the following criteria to be eligible for the study: Healthy adults ages 18 to 45 years. Willingness to remain in study area for the period of the study. Able and willing (in the Investigator's opinion) to comply with all study requirements. Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo‐progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points. Agreement to refrain from blood donation during the course of the study. Written informed consent to participate in the trial.
Epistemonikos ID: 3d3f6ebd95a8df906d15565dcb3594c22d74aa6a
First added on: Aug 24, 2024