a first-in-human study to evaluate jcxh-105, an srrna-based herpes zoster vaccine

Conditions: Herpes Zoster (HZ); Shingles; Infectious Disease

Summary: the goal of this clinical trial is to assess the safety and immunogenicity of a self-replicating (sr) rna-based vaccine, jcxh-105, in the prevention of shingles (herpes zoster) participant will be randomized to receive either jcxh-105 or shingrix.

this phase 1 study plans to enroll a total of 75 participants. three cohorts with 3 different dose levels of jcxh-105 will be explored and each cohort will enroll 25 participants (20 randomized to jcxh-105 and 5 randomized to shingrix) for a total of 75 participants. the dose level of jcxh-105 will depend on the time the participant joins the study. each participant will receive two single intramuscular (im) injections of study treatment (jcxh-105 or shingrix) on day 1 and day 61 (±2 days on day 61)

Eligibility criteria:
inclusion criteria: * sex: male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * age: 50 to 69 years of age, inclusive, at screening. * status: healthy subjects. note: healthy status as defined by the absence of evidence of any clinically significant active or chronic disease, in the opinion of the investigator, following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ecg) recording, hematology, blood chemistry, serology, and urinalysis. healthy subjects may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment. * subjects must agree to not be vaccinated with any hz vaccine while participating in this study. * all values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations based on medical history, considering stable pre-existing diseases (see healthy subjects above), as judged by the investigator. exclusion criteria: * subjects with a history of hz or current diagnosis of shingles. * 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 with history of myocarditis or pericarditis, or with aes after mrna vaccination that are in nature and severity beyond the common expected aes necessitating medical intervention. * subjects who have received an mrna-based vaccine (e.g., spikevax, comirnaty, etc.) 30 days prior to day 1. * subjects who received any non-live vaccine within 14 days prior to the first vaccine administration (jcxh-105 or shingrix). * subjects who received within 28 days prior to first vaccine administration (jcxh-105 or shingrix): (1) any live vaccine, (2) immunomodulators or immune-suppressive medication, (3) 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 with active or suspected immunosuppression, immunodeficiency, or autoimmune disease. * 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. * subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (sars-cov-2). * subjects with a known history of active or latent tuberculosis (bacillus tuberculosis).

Keywords: srrna vaccine shingles vaccine herpes zoster (hz) vaccine healthy adult participants (aged 50 to 69 years)