Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461026
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-11
Brief Title:
L9LS MAb in Malian Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1b Randomized Double-Blind Placebo-Controlled Trial to Assess the Safety Tolerability and Pharmacokinetics of L9LS in Infants in Mali and to Evaluate the Impact of L9LS on Subsequent R21Matrix-MTM Vaccine Immunogenicity
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to assess the safety tolerability and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21Matrix-MTM vaccine immunogenicity
Detailed Description:
This is an age-stratified randomized double-blind placebo-controlled trial evaluating the safety tolerability and pharmacokinetics PK of 1-time intramuscular IM administration of the monoclonal antibody MAb L9LS to healthy Malian infants aged 1 to 12 months followed by an assessment of the impact of L9LS on the immunogenicity of subsequent administration of the R21Matrix-MTM vaccine The study hypotheses are that L9LS will be safe and will not impact the immunogenicity of the R21Matrix-MTM vaccine During the beginning of the 6-month malaria season approximately August and September at the study site 180 participants will be enrolled and randomized 11 to receive 150 mg of L9LS n90 or normal saline placebo n90 Randomization of participants in each arm will be age-stratified 1 to 4 months n60 4 to 8 months n60 8 to 12 months n60 The safety of L9LS will be assessed within each of the 3 age strata Participants will be followed at study visits 1 3 7 14 21 and 28 days later and once every 4 weeks thereafter through study day 280 40 weeks Approximately 5 months after receiving L9LS or placebo all participants will receive the R21Matrix-MTM vaccine as 3 total doses given 4 weeks apart as per World Health Organization WHO recommendations and the anticipated Malian vaccination guidelines Primary study assessments include medical history physical examination and blood collection to assess antibody responses to the R21Matrix-MTM vaccine L9LS 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 Through their local provider all participants 3 months and older will be offered 4 rounds of seasonal malaria chemoprevention SMC as a monthly 3-day treatment course of sulfadoxine-pyrimethamine plus amodiaquine SPAQ as it is the standard of care in Mali for malaria prevention in children 3 months to 5 years of age
Study Oversight
Has Oversight DMC:
None
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?:
None