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| Name | Class |
|---|---|
| Abogen Biosciences (Shanghai) Co., Ltd | INDUSTRY |
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The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of 2 injections (approximately 2 months apart) of three different dose levels of ABO1108 in adults aged 40 years or above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose level A in adults aged 40 years or above | Other | Two injections of Dose level A of ABO1108 or placebo or active competitor given approximately 60 days apart |
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| Cohort 2: Dose level B in adults aged 40 years or above | Other | Two injections of Dose level B of ABO1108 or placebo or active competitor given approximately 60 days apart |
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| Cohort 3: Dose level C in adults aged 40 years or above | Other | Two injections of Dose level C of ABO1108 or placebo or active competitor given approximately 60 days apart |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO1108 | Biological | Formulation for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited AEs and ARs after each dose | up to day 74 (14 days after each dose) | |
| Incidence of unsolicited AEs and ARs after each dose | up to day 90 (30 days after each dose) |
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Inclusion Criteria:
Exclusion Criteria:
Acute illness or fever on the day of vaccination or within 3 days prior to vaccination, or use of anti-inflammatory, anti-allergy, antibiotic, or antiviral medications due to physical discomfort.
Clinically significant abnormal vital signs, including but not limited to:
Clinically significant abnormalities of laboratory indicators or 12-lead ECG during the screening period.
Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
History of allergy to the investigational product or its excipients, or severe allergic reactions to other vaccines, foods, or medications.
History of herpes zoster at any previous time, history of varicella or close contact with varicella/herpes zoster patients within the past year.
Previous vaccination with herpes zoster or varicella vaccine (including marketed or investigational vaccines) or planned vaccination during the trial period.
Use or planned use of any vaccine other than the investigational products through 30 days prior to and 30 days after vaccinations in this trial.
Current participation in another clinical trial within 6 months prior to vaccination or planned participation before the end of this trial.
Clinician-diagnosed coagulation abnormalities.
Known medical history or diagnosis confirming the subject has a condition affecting immune system function.
History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any condition that may increase the risk of myocarditis or pericarditis.
Severe or uncontrolled respiratory, cardiovascular, neurological, hematological, lymphatic, hepatic, renal, metabolic, or skeletal diseases; known severe congenital malformations; developmental disorders; or clinically diagnosed severe chronic conditions that may affect trial outcomes.
Current infectious period of any communicable disease, acute infection, or acute phase of chronic infection, or ongoing anti-tuberculosis treatment; or prior positive test for hepatitis B surface antigen, hepatitis C virus antibody, or Treponema pallidum antibody.
Past or current diagnosis of neurological or psychiatric disorders, or family history of neurological/psychiatric disorders; or other neurological conditions deemed unsuitable for trial participation by the investigator.
Long-term use of immunosuppressants or immunomodulators through 6 months prior to and one month after the last vaccination, excluding topical medications. Topical medications should not exceed recommended doses or induce systemic exposure.
Treatment with immunoglobulins and/or blood products or blood donation through 3 months prior to and 3 months after the last vaccination in this trial.
Suspected or known alcohol dependence or drug abuse, which may affect safety assessment or trial compliance.
Planned long-term or permanent relocation away from the trial site area before trial completion.
Investigators, sponsors, and contract research organization (CRO) staff directly involved in the trial.
Other circumstances deemed unsuitable for trial participation by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rongshui Miao Autonomous County Center for Disease Control and Prevention | Liuzhou | Rongshui | China |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Placebo | Drug | 0.9% sodium chloride (normal saline) injection |
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| SHINGRIX | Biological | • Formulation for injection |
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| D007239 | Infections |