Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07208760
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.
Study:
NCT07208760
Study Brief:
Protocol Section:
NCT07208760