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.
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 (4:1) to receive either JCXH-108 (n=20) or placebo (normal saline, n=5). 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
75
Health Awareness
Jupiter, Florida, United States
DelRicht - New Orleans
New Orleans, Louisiana, United States
Sundance Clinical Research
St Louis, Missouri, United States
SAE Frequency
Frequency of SAEs characterized by type, severity, duration, and relationship to the JCXH-108 recorded from Day 1 (D1) post-vaccine administration through follow-up completion.
Time frame: Day 1 - Day 180 (6 Months)
Injection site reaction
Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)
Time frame: Day 1 - Day 30
Solicited systemic reaction frequency
Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)
Time frame: Day 1 - Day 30
AE frequency
Adverse events (AEs) including unsolicited AEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration to within 30 days following vaccine administration
Time frame: Day 1 -Day 30
Medically attended AE frequency
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
Time frame: Day 1 - Day 180 (6 Months)
Potential immune-mediated adverse events frequency
Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
Time frame: Day 1 - Day 180 (6 Months)
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RSV-A and RSV-B antibody levels
Levels of serum neutralizing antibodies against RSV-A and RSV-B as compared to Day 1 pre-dose (baseline) at Day 29, Month 3 and Month 6 after the vaccine administration
Time frame: Day 1 - Day 180 (6 Months)
IgG antibody levels
Levels of serum RSV pre-F antibodies of IgG1, IgG2, IgG3, and IgG4 as compared to Day 1 pre-dose (baseline) at Day 29, after the vaccine administration. Measured in women of childbearing potential only.
Time frame: Day 1 - Day 30