Varicella-zoster VirusPhase 3NCT07817108
Phase III Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above
A Phase 3 study testing ABO1108 in people with Varicella-zoster Virus, run by Suzhou Abogen Biosciences Co., Ltd. at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella-zoster Virus
- What is being tested?
- ABO1108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,000 participants
- Where
- 4 sitesChina
- Study dates
- 27 Jun 2026to 17 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- Chinese male or female aged ≥40 year. Participants with underlying medical conditions may be enrolled if their conditions are stably controlled;
- Be able to communicate well with the investigator, understand and comply with the protocol requirements for trial participation;
- 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.
Who cannot join
- 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;
- 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;
- Female participants who are known to be pregnant or breastfeeding, or who have a positive pregnancy test if of childbearing potential;
- History of allergy to any component of the investigational vaccine, or history of severe allergic reactions to other vaccines, foods, or drugs;
- 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;
- Previous or planned vaccination with herpes zoster or varicella vaccines (including licensed or unlicensed vaccines) during the trial period;
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- 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;
- 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;
- History of clinically diagnosed coagulation abnormalities or coagulation disorders, or contraindications to intramuscular injection such as receiving anticoagulant therapy;
- 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;
- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
- 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;
- Acute infection, acute phase of chronic infection, or currently receiving anti tuberculosis treatment, or those with a previous positive treponemal antibody test;
- 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;
- Current skin diseases that, in the investigator's judgment, may affect trial observations;
- 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;
- 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;
- Suspected or known drug abuse that, in the investigator's opinion, may affect safety evaluation or trial compliance;
- Investigators at the trial site/study site, or employees of the sponsor or third party monitoring company involved in the trial;
- Other conditions that the investigator deems unsuitable for participation in this trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Shandong Center for Disease Control and Prevention
Jinan
Li Zhang, zltrial@vip.163.com
- Recruiting
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning
Teng Huang, 0771-2518136, huangt24@126.com
- Recruiting
Hebei Province Center for Disease Control and Prevention
Shijiazhuang
Minjie Li, 0311-86573212, liminjie507@163.com
- Recruiting
Zhejiang Center for Disease Control and Prevention
Zhejiang
Shenyu Wang, sywang@cdc.zj.cn
About this study
Official title: 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.
- Conditions
- Varicella-zoster Virus
- Being tested
- ABO1108, Placebo
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO1108Biological
Formulation for injection
PlaceboDrug
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Group1: Experimental group in adults aged 40 or above | Experimental | Two injections of ABO1108 given approximately 60 days apart Receives: Biological: ABO1108 |
| Group 2: Placebo control in adults aged 40 or above | Placebo comparator | Two injections of placebo given approximately 60 days apart Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed herpes zoster incidence rate per person-year]
Measured: ≥30 days after receiving two doses of the study vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Jun 2026
- Primary completion17 Oct 2027 (estimated)
- Study completion17 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella-zoster VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Teng Huang, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817108
- Sponsor's protocol ID
- ABO1108-301
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07817108
- Acronym / sponsor ID
- ABO1108-301
- Conditions
- Varicella-zoster Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abogen Biosciences (Shanghai) Co., Ltd
- Study start
- 27 Jun 2026 (actual)
- Primary completion
- 17 Oct 2027 (estimated)
- Study completion
- 17 Oct 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Experimental group in adults aged 40 or above | Experimental | Biological: ABO1108Two injections of ABO1108 given approximately 60 days apart |
| Group 2: Placebo control in adults aged 40 or above | Placebo comparator | Drug: PlaceboTwo injections of placebo given approximately 60 days apart |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- Chinese male or female aged ≥40 year. Participants with underlying medical conditions may be enrolled if their conditions are stably controlled;
- Be able to communicate well with the investigator, understand and comply with the protocol requirements for trial participation;
- 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.
Key exclusion criteria (20 listed)
- 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;
- 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;
- Female participants who are known to be pregnant or breastfeeding, or who have a positive pregnancy test if of childbearing potential;
- History of allergy to any component of the investigational vaccine, or history of severe allergic reactions to other vaccines, foods, or drugs;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABO1108Formulation for injection | Biological | Group1: Experimental group in adults aged 40 or above |
| Placebo0.9% sodium chloride (normal saline) injection | Drug | Group 2: Placebo control in adults aged 40 or above |
Primary outcome
Confirmed herpes zoster incidence rate per person-year]
Time frame: ≥30 days after receiving two doses of the study vaccine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teng Huang principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABO1108 in people with Varicella-zoster Virus, run by Suzhou Abogen Biosciences Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shihui Fu (0512-69150735, Shihui.fu@abogenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed herpes zoster incidence rate per person-year] (time frame: ≥30 days after receiving two doses of the study vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.