Viewing Study NCT05790889



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Last Modification Date: 2024-10-26 @ 2:55 PM
Study NCT ID: NCT05790889
Status: RECRUITING
Last Update Posted: 2023-10-23
First Post: 2023-01-16

Brief Title: A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso
Sponsor: University of Oxford
Organization: University of Oxford

Study Overview

Official Title: A Phase IIb Randomised Controlled Trial of the Safety Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH51 in Matrix-MTM and RH52-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso
Status: RECRUITING
Status Verified Date: 2022-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a Phase IIb randomised controlled trial of the safety immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH51 in Matrix-MTM and RH52-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
Detailed Description: During the initial recruitment to Groups 1 and 2 participants will be randomised 12 to receive vaccination with the rabies control vaccination or RH51Matrix-M

During recruitment to Groups 3 4 and 5 participants will be randomised 122 to receive vaccination with rabies control vaccination RH51Matrix-M or RH52-VLPMatrix-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 24 and 5

There are three study vaccines the IMP 10μg RH51 adjuvanted with Matrix-M 5μg RH52-VLP and Rabies Vaccine Participants will receive the first vaccination of RH51 10μg with 50μg Matrix-M Groups 2 and 4 or RH52 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None