En fase 2-studie for å evaluere JCXH-105, en SrRNA-basert herpes zoster-vaksine
En fase 2, randomisert, trippelblindet, aktivt kontrollert studie for å vurdere sikkerheten og immunogenisiteten til en undersøkende herpes zoster (HZ) vaksine, JCXH-105, hos friske personer ≥ 50 år.
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Arizona
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Tucson, Arizona, Forente stater, 85704
- Noble Clinical Research
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California
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Long Beach, California, Forente stater, 90805
- Long Beach Research Institute
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Illinois
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Chicago, Illinois, Forente stater, 60652
- DM Clinical Research - Chicago
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Quality Clinical Research
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New Jersey
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Jersey City, New Jersey, Forente stater, 07306
- DM Clinical Research - New Jersey
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South Carolina
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Charleston, South Carolina, Forente stater, 29407
- Delricht Research
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Texas
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Prosper, Texas, Forente stater, 75078
- Delricht Research
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Sugar Land, Texas, Forente stater, 77478
- DM Clinical Research - Sugarland
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Investigational Product
Participants randomized to this arm will be given the investigational product (JCXH-105). |
IM injection |
|
Aktiv komparator: Active Control
Participants randomized to this arm will be given the FDA approved Shingrix. |
IM injection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SAE Frequency
Tidsramme: 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. |
Day 1 - Day 241 (Week 34)
|
|
Solicited local reaction frequency
Tidsramme: 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. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
Solicited systemic reaction frequency
Tidsramme: 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. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
AE Frequency
Tidsramme: 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. |
Day 1 - Day 241 (Week 34)
|
|
AESIs Frequency
Tidsramme: 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. |
Day 1 - Day 241 (Week 34)
|
|
Medically Attended AE Frequency
Tidsramme: 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. |
Day 1 - Day 241 (Week 34)
|
|
Immune-Mediated Adverse Events of Special Interest Frequency
Tidsramme: 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. |
Day 1 - Day 241 (Week 34)
|
|
gE-Specific CD4+ T cell Response Rate
Tidsramme: 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). |
Day 1 - Day 89 (Week 13)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cellular immunogenicity of JCXH-105
Tidsramme: Day 1 - Day 241 (Week 34)
|
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). |
Day 1 - Day 241 (Week 34)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cellular Immunogenicity of JCXH-105
Tidsramme: Day 1 - Day 241 (Week 34)
|
Frequency of gE-specific CD8+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
|
Humoral immunogenicity of JCXH-105
Tidsramme: Day 1 - Day 241 (Week 34)
|
Changes in serum of anti-gE-specific antibody geometric mean titers (GMTs) analyzed with enzyme-linked immunosorbent assay (ELISA) on Day 29, Day 89, and Day 241 as compared to baseline (D1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JCXH-105-021
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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