Infectious Disease, Respiratory Syncytial Virus (RSV)
Conditions
Keywords
mRNA vaccine, RSV vaccination, Healthy subjects
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.
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 (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.
Interventions
BIOLOGICALJCXH-108
IM injection
OTHERPlacebo
IM injection
Sponsors
Immorna Biotherapeutics, Inc.
Tigermed Consulting Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * Sex: Male or female; female subjects may be of childbearing potential or postmenopausal. * Age: 18-45 years of age or ≥ 60 years of age at screening * Status: Healthy subjects. * Subjects must agree to not be vaccinated with any RSV vaccine while participating in this study. * Subjects must agree to not be vaccinated with any RNA-based vaccines 30 days before D1 through 30 days after D1. Main
Exclusion criteria
* Subjects with current diagnosis of RSV infection or diseases. * Previous vaccination against RSV. * Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization \>24 hours for any reason within the past month prior to Day 1. * Subjects with history of myocarditis or pericarditis, or with adverse events (AEs) after mRNA vaccination that are in nature and severity beyond the common expected AEs necessitating medical intervention. * Subjects who received any non-live vaccine within 14 days prior to Day 1. * Subjects who received within 28 days prior to Day 1: (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, and (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable dose of steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed. * Subjects who currently receive other investigational agents or devices. * Subjects with active or suspected immunosuppression, immunodeficiency, asplenia, recurrent severe infections or autoimmune diseases. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed. * Subjects receiving systemic antiviral therapy. * Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human HIV-1 and 2 antibodies, syphilis. * Subjects with a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or on Day 1 prior to vaccine administration (JCXH-108 or placebo).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAE Frequency | Day 1 - Day 180 (6 Months) | 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. |
| Injection site reaction | Day 1 - Day 30 | Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo) |
| Solicited systemic reaction frequency | Day 1 - Day 30 | Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo) |
| AE frequency | Day 1 -Day 30 | 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 |
| Medically attended AE frequency | Day 1 - Day 180 (6 Months) | 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 |
| Potential immune-mediated adverse events frequency | Day 1 - Day 180 (6 Months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A and RSV-B antibody levels | Day 1 - Day 180 (6 Months) | 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 |
| IgG antibody levels | Day 1 - Day 30 | 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. |
Countries
United States
Outcome results
None listed