Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564194
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Phase 1 Study to Evaluate JCXH-108 an MRNA-based Vaccine Against RSV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blinded Study to Assess the Safety Reactogenicity and Immunogenicity of JCXH-108 an MRNA-based Investigational Vaccine Against Respiratory Syncytial Virus RSV in Healthy Subjects 60 Years of Age and 18-45 Years of Age
Status:
RECRUITING
Status Verified Date:
2024-09
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 goal of this clinical trial is to assess the safety reactogenicity and immunogenicity of an mRNA-based vaccine JCXH-108 the prevention of Respiratory Syncytial Virus RSV infection and diseases
Participants will be randomized to receive either JCXH-108 or placebo
Participants will be randomized to receive either JCXH-108 or placebo
Detailed Description:
This Phase 1 study plans to enroll a total of 75 participants
Three cohorts with two different dose levels will be explored and each cohort will enroll 25 participants Participants in each cohort will be randomized 41 to receive either JCXH-108 n20 or placebo normal saline n5 A low dose of JCXH-108 will be explored vs placebo in the 18-45 years of age group first A high dose will be explored vs placebo in the 18-45 years and 60 years of age groups once safety data is reviewed for the Sentinel subjects in the low dose cohort The dose level of JCXH-108 will depend on the time the participant joins the study Each participant will receive a single dose of JCXH-108 administered intramuscularly IM on day 1
Three cohorts with two different dose levels will be explored and each cohort will enroll 25 participants Participants in each cohort will be randomized 41 to receive either JCXH-108 n20 or placebo normal saline n5 A low dose of JCXH-108 will be explored vs placebo in the 18-45 years of age group first A high dose will be explored vs placebo in the 18-45 years and 60 years of age groups once safety data is reviewed for the Sentinel subjects in the low dose cohort The dose level of JCXH-108 will depend on the time the participant joins the study Each participant will receive a single dose of JCXH-108 administered intramuscularly IM on day 1
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