Phase III Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above

September 8, 2026 updated by: Suzhou Abogen Biosciences Co., Ltd.

A Phase III Randomized, Double-blind, Placebo-controlled Trial Evaluating the Vaccine Efficacy, Safety, and Immunogenicity of a Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged ≥40 Years

The primary objective of this study is to evaluate the vaccine efficacy, safety and immunogenicity of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Shandong Center for Disease Control and Prevention
        • Contact:
      • Nanning, China
        • Recruiting
        • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
        • Contact:
      • Shijiazhuang, China
        • Recruiting
        • Hebei Province Center for Disease Control and Prevention
        • Contact:
      • Zhejiang, China
        • Recruiting
        • Zhejiang Center for Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be able and willing to comply with the protocol requirements for all scheduled follow up visits, agree to participate in the trial, and voluntarily sign the ICF approved by EC;
  2. Chinese male or female aged ≥40 year. Participants with underlying medical conditions may be enrolled if their conditions are stably controlled;
  3. Be able to communicate well with the investigator, understand and comply with the protocol requirements for trial participation;
  4. Female participants of childbearing potential and male participants (whose female partners are of childbearing potential) must have practiced effective contraception from the end of the last menstrual cycle of the female participant or partner until the day of vaccination, and must continue to use effective contraception for 6 months after completion of the voluntary vaccination. During this period, they must also refrain from donating sperm or ova. Alternatively, female participants may be considered not of childbearing potential.

Exclusion Criteria:

  1. Within 3 days prior to vaccination, presence of acute illness, acute exacerbation of chronic disease, or febrile/near febrile state, or use of anti inflammatory drugs, antibiotics, antihistamines, or antiviral drugs due to physical discomfort;
  2. On the day of vaccination, for participants aged 40-59 years, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; for participants aged ≥60 years, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
  3. Female participants who are known to be pregnant or breastfeeding, or who have a positive pregnancy test if of childbearing potential;
  4. History of allergy to any component of the investigational vaccine, or history of severe allergic reactions to other vaccines, foods, or drugs;
  5. History of herpes zoster (shingles), history of varicella (chickenpox) within the past year, or close contact with individuals with varicella/herpes zoster within the past year;
  6. Previous or planned vaccination with herpes zoster or varicella vaccines (including licensed or unlicensed vaccines) during the trial period;
  7. Use of any vaccine within 30 days prior to vaccination, or planned use of any vaccine other than the investigational vaccine within 30 days after administration of the investigational vaccine;
  8. Current participation in another drug or medical device clinical trial within 6 months prior to vaccination, or planned participation in such a trial before the end of this trial;
  9. History of clinically diagnosed coagulation abnormalities or coagulation disorders, or contraindications to intramuscular injection such as receiving anticoagulant therapy;
  10. Known medical history or diagnosis confirming that the participant has or has had a disease affecting immune system function, including malignancies, congenital or acquired immunodeficiencies, autoimmune diseases, or other conditions affecting immune function;
  11. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
  12. Uncontrolled cardiovascular diseases, severe or uncontrolled respiratory diseases, neurological diseases, hematological and lymphatic diseases, liver and kidney diseases, metabolic and skeletal system diseases, or known severe congenital malformations, developmental disorders, or clinically diagnosed severe chronic diseases that, in the investigator's judgment, may affect the trial results;
  13. Acute infection, acute phase of chronic infection, or currently receiving anti tuberculosis treatment, or those with a previous positive treponemal antibody test;
  14. History or current presence of clearly diagnosed neurological diseases or psychiatric disorders or family history of neurological/psychiatric diseases, receipt of facial fillers within 6 months prior to vaccination, and other neurological diseases that the investigator deems unsuitable for participation;
  15. Current skin diseases that, in the investigator's judgment, may affect trial observations;
  16. Use of long term immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to vaccination, or planned use during the period from enrollment to 1 month after the full course of vaccination, with the exception of topical drugs. Topical drugs should not exceed the recommended dose in the package insert or induce signs of systemic exposure. Long term systemic corticosteroids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent;
  17. Receipt of immunoglobulins and/or blood products, or blood donation, within 3 months prior to vaccination, or planned during the period from enrollment to 1 month after the full course of vaccination;
  18. Suspected or known drug abuse that, in the investigator's opinion, may affect safety evaluation or trial compliance;
  19. Investigators at the trial site/study site, or employees of the sponsor or third party monitoring company involved in the trial;
  20. Other conditions that the investigator deems unsuitable for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1: Experimental group in adults aged 40 or above
Two injections of ABO1108 given approximately 60 days apart
Biological: ABO1108
Formulation for injection
Placebo Comparator: Group 2: Placebo control in adults aged 40 or above
Two injections of placebo given approximately 60 days apart
Drug: Placebo
0.9% sodium chloride (normal saline) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirmed herpes zoster incidence rate per person-year]
Time Frame: ≥30 days after receiving two doses of the study vaccine
≥30 days after receiving two doses of the study vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Abogen Biosciences Co., Ltd.

Collaborators

Abogen Biosciences (Shanghai) Co., Ltd

Investigators

  • Principal Investigator: Teng Huang, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2026

Primary Completion (Estimated)

October 17, 2027

Study Completion (Estimated)

October 17, 2027

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABO1108-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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