New shingles vaccine shows promise in Head-to-Head trial
NCT ID NCT06581575
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new shingles vaccine called JCXH-105 in healthy adults aged 50 and older. It compares the new vaccine to the current standard, Shingrix, to see if it is safe and triggers a strong immune response. About 467 participants will receive either JCXH-105 or Shingrix, and researchers will monitor side effects and immune markers over several months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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467 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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: * 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. * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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DM Clinical Research - Chicago
Chicago, Illinois, 60652, United States
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DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306, United States
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DM Clinical Research - Sugarland
Sugar Land, Texas, 77478, United States
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Delricht Research
Charleston, South Carolina, 29407, United States
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Delricht Research
Prosper, Texas, 75078, United States
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Long Beach Research Institute
Long Beach, California, 90805, United States
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Noble Clinical Research
Tucson, Arizona, 85704, United States
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Quality Clinical Research
Omaha, Nebraska, 68114, United States
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Other studies related to the condition(s) this trial covers.
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