Clinical trial NCT06564194: A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Respiratory Syncytial Virus (RSV)
Infectious Disease
Keywords: mRNA vaccine
RSV vaccination
Healthy subjects
Lead sponsor: Immorna Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2024-08-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: SAE Frequency
timeFrame: Day 1 - Day 180 (6 Months)
measure: Injection site reaction
timeFrame: Day 1 - Day 30
measure: Solicited systemic reaction frequency
timeFrame: Day 1 - Day 30
measure: AE frequency
timeFrame: Day 1 -Day 30
measure: Medically attended AE frequency
timeFrame: Day 1 - Day 180 (6 Months)
measure: Potential immune-mediated adverse events frequency
timeFrame: Day 1 - Day 180 (6 Months)
Secondary outcomes:
measure: RSV-A and RSV-B antibody levels
timeFrame: Day 1 - Day 180 (6 Months)
measure: IgG antibody levels
timeFrame: Day 1 - Day 30
Other outcomes:
measure: T-cell responses
timeFrame: Day 1 -Day 180 (6 Months)
Locations:
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: New Orleans
country: United States
facility: DelRicht - New Orleans
state: Louisiana
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
Study officials:
References: