Respiratory Syncytial Virus (RSV)Phase 1NCT06564194
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
A Phase 1 study testing JCXH-108 in people with Respiratory Syncytial Virus (RSV) and Infectious Disease, run by Immorna Biotherapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Infectious Disease
- What is being tested?
- JCXH-108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Sep 2024to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Health Awareness
Jupiter, Florida, 33458
DelRicht - New Orleans
New Orleans, Louisiana, 70115
Sundance Clinical Research
St Louis, Missouri, 63131
About this study
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
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.
Read the 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.
- Being tested
- JCXH-108, Placebo
- Keywords
- mRNA vaccine, RSV vaccination, Healthy subjects
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-108Biological
IM injection
PlaceboOther
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | Subjects randomized to this arm will be given the investigational product (JCXH-108). Receives: Biological: JCXH-108 |
| Placebo | Placebo comparator | Subjects randomized to this arm will be given a placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 - Day 180 (6 Months)
Secondary outcomes (2)
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
Measured: 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.
Measured: Day 1 - Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start25 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immorna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564194
- Sponsor's protocol ID
- JCXH-108-001
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06564194
- Acronym / sponsor ID
- JCXH-108-001
- Keywords
- mRNA vaccine, RSV vaccination, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Biological: JCXH-108Subjects randomized to this arm will be given the investigational product (JCXH-108). |
| Placebo | Placebo comparator | Other: PlaceboSubjects randomized to this arm will be given a placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JCXH-108IM injection | Biological | Investigational product |
| PlaceboIM injection | Other | Placebo |
Primary outcome
SAE Frequency
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
RSV-A and RSV-B antibody levels
Time frame: Day 1 - Day 180 (6 Months)
IgG antibody levels
Time frame: Day 1 - Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Respiratory Syncytial Virus (RSV)
RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
RSV Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JCXH-108 in people with Respiratory Syncytial Virus (RSV) and Infectious Disease, run by Immorna Biotherapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAE Frequency (time frame: Day 1 - Day 180 (6 Months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.