Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507605
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Randomized Double-blind Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in Healthy African Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 individually randomized double-blind dose escalating study designed to evaluate the safety tolerability and immunogenicity of Pfs230D1 conjugate vaccines R21 nanoparticle vaccine or their combination conjugate vaccines formulated on Matrix-M in healthy African adults aged 18 to 50 years
Detailed Description:
240 healthy adults 18-50 years of age will be enrolled from Mali Africa in a staggered manner by increasing Pfs230D1 dosing
Participants will be randomized by cohorts as detailed below to one of the study arms to receive single antigen Pfs230D1 or R21 or combination Pfs230D1 R21 with 50 μg of Matrix-M all administered as an IM injection on a 1 29 57-day schedule Participants will be followed for safety for 6 months post last dose with continued assessment for clinical malaria cases and immunogenicity up until 12 months post last dose
Cohort 1 n120 111111
Arm 1a n20 6μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 1b n20 6μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 1c n20 12μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 1d n20 12μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 1e n20 5μg of R21 in 50μg Matrix-M
Arm 1f n20 10μg of R21 in 50μg Matrix-M
Followed by Cohort 2 n80 1111
Arm 2a n20 20μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 2b n20 20μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 2c n20 20μg Pfs230D1-CRM197 in 50μg Matrix-M
Arm 2d n20 20μg Pfs230D1-EPA 5μg of R21 in 50μg Matrix-M
Followed by Cohort 3 n40 11
Arm 3a n20 40μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 3b n20 40μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Participants will be randomized by cohorts as detailed below to one of the study arms to receive single antigen Pfs230D1 or R21 or combination Pfs230D1 R21 with 50 μg of Matrix-M all administered as an IM injection on a 1 29 57-day schedule Participants will be followed for safety for 6 months post last dose with continued assessment for clinical malaria cases and immunogenicity up until 12 months post last dose
Cohort 1 n120 111111
Arm 1a n20 6μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 1b n20 6μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 1c n20 12μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 1d n20 12μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 1e n20 5μg of R21 in 50μg Matrix-M
Arm 1f n20 10μg of R21 in 50μg Matrix-M
Followed by Cohort 2 n80 1111
Arm 2a n20 20μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 2b n20 20μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Arm 2c n20 20μg Pfs230D1-CRM197 in 50μg Matrix-M
Arm 2d n20 20μg Pfs230D1-EPA 5μg of R21 in 50μg Matrix-M
Followed by Cohort 3 n40 11
Arm 3a n20 40μg Pfs230D1-CRM197 5μg of R21 in 50μg Matrix-M
Arm 3b n20 40μg Pfs230D1-CRM197 10μg of R21 in 50μg Matrix-M
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None