Herpes Zoster (HZ)Phase 2NCT06581575
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
A Phase 2 study testing JCXH-105 and Shingrix in people with Herpes Zoster (HZ) and Infectious Diseases, run by Immorna Biotherapeutics, Inc. at 8 sites in United States.
Trial summary
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster (HZ), Infectious Diseases, Shingles
- What is being tested?
- JCXH-105 and Shingrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Oct 2024to Aug 2026
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: ≥ 50 years of age at screening.
- Status: Healthy subjects.
- Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
- Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
Who cannot join
- Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
- Previous vaccination against HZ.
- 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 the first vaccine administration (JCXH-105 or Shingrix).
- Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
- Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
- Subjects with history of myocarditis or pericarditis, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
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- Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
- Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
- Subjects receiving systemic antiviral therapy.
- Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
- Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Delricht Research
Charleston, South Carolina, 29407
DM Clinical Research - Chicago
Chicago, Illinois, 60652
DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306
Long Beach Research Institute
Long Beach, California, 90805
Quality Clinical Research
Omaha, Nebraska, 68114
Delricht Research
Prosper, Texas, 75078
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478
Noble Clinical Research
Tucson, Arizona, 85704
About this study
Official title: A Phase 2, Randomized, Triple-Blinded, Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects ≥ 50 Years of Age
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
Read the detailed description
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
- Conditions
- Herpes Zoster (HZ), Infectious Diseases, Shingles
- Being tested
- JCXH-105, Shingrix
- Keywords
- srRNA, Herpes Zoster (HZ) vaccination, Healthy Subjects
- Medical subject headings
- Herpes Zoster, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-105Biological
IM injection
ShingrixBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Participants randomized to this arm will be given the investigational product (JCXH-105). Receives: Biological: JCXH-105 |
| Active Control | Active comparator | Participants randomized to this arm will be given the FDA approved Shingrix. Receives: Biological: Shingrix |
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 vaccine recorded from Day 1 post-vaccine administration through follow-up completion.
Measured: Day 1 - Day 241 (Week 34)
Solicited local reaction frequency
Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
Measured: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Solicited systemic reaction frequency
Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
Measured: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
AE Frequency
Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Measured: Day 1 - Day 241 (Week 34)
AESIs Frequency
AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Measured: Day 1 - Day 241 (Week 34)
Medically Attended AE Frequency
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Measured: Day 1 - Day 241 (Week 34)
Immune-Mediated Adverse Events of Special Interest Frequency
Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion.
Measured: Day 1 - Day 241 (Week 34)
gE-Specific CD4+ T cell Response Rate
Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose).
Measured: Day 1 - Day 89 (Week 13)
Secondary outcomes (1)
Cellular immunogenicity of JCXH-105
Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry with ICS on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose).
Measured: Day 1 - Day 241 (Week 34)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Zoster (HZ)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 467 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
- NCT06581575
- Sponsor's protocol ID
- JCXH-105-021
- Status last verified
- Apr 2026
- First submitted
- 29 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 2, Randomized, Triple-Blinded, Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects ≥ 50 Years of Age
- ClinicalTrials.gov ID
- NCT06581575
- Acronym / sponsor ID
- JCXH-105-021
- Conditions
- Herpes Zoster (HZ), Infectious Diseases, Shingles
- Keywords
- srRNA, Herpes Zoster (HZ) vaccination, Healthy Subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Sep 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 and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
Detailed description
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
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-105Participants randomized to this arm will be given the investigational product (JCXH-105). |
| Active Control | Active comparator | Biological: ShingrixParticipants randomized to this arm will be given the FDA approved Shingrix. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: ≥ 50 years of age at screening.
- Status: Healthy subjects.
- Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
- Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
Key exclusion criteria (11 listed)
- Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
- Previous vaccination against HZ.
- 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 the first vaccine administration (JCXH-105 or Shingrix).
- Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
- Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
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-105IM injection | Biological | Investigational Product |
| ShingrixIM injection | Biological | Active Control |
Primary outcome
SAE Frequency
Time frame: Day 1 - Day 241 (Week 34)
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion.
Solicited local reaction frequency
Time frame: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
Solicited systemic reaction frequency
Time frame: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
AE Frequency
Time frame: Day 1 - Day 241 (Week 34)
Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
AESIs Frequency
Time frame: Day 1 - Day 241 (Week 34)
AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Medically Attended AE Frequency
Time frame: Day 1 - Day 241 (Week 34)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Immune-Mediated Adverse Events of Special Interest Frequency
Time frame: Day 1 - Day 241 (Week 34)
Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion.
gE-Specific CD4+ T cell Response Rate
Time frame: Day 1 - Day 89 (Week 13)
Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose).
1 secondary outcome
Cellular immunogenicity of JCXH-105
Time frame: Day 1 - Day 241 (Week 34)
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.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JCXH-105 and Shingrix in people with Herpes Zoster (HZ) and Infectious Diseases, run by Immorna Biotherapeutics, Inc. at 8 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?
The sponsor lists 5 inclusion and 11 exclusion criteria. 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 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 241 (Week 34)). The study lists 8 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; AzTrials last refreshed its copy on 26 Oct 2026.