Ignite Creation Date:
2024-05-06 @ 6:49 PM
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
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