Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT07208760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L9LS-R21 Interaction
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of L9LS on R21/Matrix-M™ Vaccine Immunogenicity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
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 randomized, double-blind, placebo-controlled trial in 2 parts evaluating the effect of 1-time administration of the monoclonal antibody (MAb) L9LS to healthy Malian participants on the immunogenicity of subsequent administration of the R21/Matrix-M™ vaccine. L9LS will be administered subcutaneously (SC) for adults and infants. The study will assess how the timing of L9LS administration impacts immunogenicity following subsequent intramuscular (IM) R21/Matrix-M™ vaccination. Twenty-four adult participants and 333 infant participants will be enrolled.
Detailed Description:
In Part 1, 24 adult participants will be randomized 1:1 to receive 1800 mg of L9LS or normal saline placebo at enrollment, followed by the R21/Matrix-M™ 3-dose initial vaccine series starting on day 7. Adult participants will be followed at study visits 7 days after L9LS administration and 7 days after each R21/Matrix-M™ vaccination. If no significant safety concerns arise through 7 days after administration of the first R21/Matrix-M™ vaccine (day 14) per an interim safety review, the study will proceed to Part 2. There will also be study visits 28 and 84 days following the last R21/Matrix-M™ vaccine to assess immune responses.
In Part 2, 333 infant participants will be randomized into 1 of 3 cohorts, each with an L9LS arm and a placebo arm (2:1). The individual cohorts will differ in the timing of the R21/Matrix-M™ 3-dose initial vaccine series (7 days, 2 months, and 4 months between L9LS and first R21/Matrix-M™ respectively). Infant participants will be followed at study visits 7 days after L9LS administration and 7 days after each R21/Matrix-M™ vaccination, after which they will continue to be followed every 28 days through the fourth (booster) dose of the R21/Matrix-M™ vaccine. There will also be study visits 28 and 84 days following the last R21/Matrix-M™ vaccine to assess immune responses. Primary study assessments include medical history, physical examination, and blood collection to assess antibody responses to the R21/Matrix-M™ vaccine, L9LS pharmacokinetics (PK), anti-drug antibody (ADA) assessments, identification of Plasmodium falciparum (Pf) infection by microscopic examination of thick blood smears and reverse transcription polymerase chain reaction (RT-PCR), and other research laboratory evaluations.
In Part 2, 333 infant participants will be randomized into 1 of 3 cohorts, each with an L9LS arm and a placebo arm (2:1). The individual cohorts will differ in the timing of the R21/Matrix-M™ 3-dose initial vaccine series (7 days, 2 months, and 4 months between L9LS and first R21/Matrix-M™ respectively). Infant participants will be followed at study visits 7 days after L9LS administration and 7 days after each R21/Matrix-M™ vaccination, after which they will continue to be followed every 28 days through the fourth (booster) dose of the R21/Matrix-M™ vaccine. There will also be study visits 28 and 84 days following the last R21/Matrix-M™ vaccine to assess immune responses. Primary study assessments include medical history, physical examination, and blood collection to assess antibody responses to the R21/Matrix-M™ vaccine, L9LS pharmacokinetics (PK), anti-drug antibody (ADA) assessments, identification of Plasmodium falciparum (Pf) infection by microscopic examination of thick blood smears and reverse transcription polymerase chain reaction (RT-PCR), and other research laboratory evaluations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: