Phase II Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above (NCT07285278) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above
China300 participantsStarted 2025-11-15
Plain-language summary
The primary objective of this study is to evaluate the immunogenicity and safety of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the Informed Consent Form (ICF) approved by the Ethics Committee and agree to participate in the trial before undergoing any trial procedures.
. Healthy adults ≥40 years of age, participants with underlying diseases that are stably controlled may be accepted.
. Willing to and physically able to communicate with the investigators, understand and comply with protocol required follow-up, simple self-observation and recording using the Diary Card.
. Male participants (and their female partners) and female participants of childbearing potential agree to continue effective contraception through 6 months following vaccination.
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:
. Female participants known to be pregnant or breastfeeding, or positive pregnancy test for women of childbearing potential.
. History of allergy to any ingredient of the investigational products, or severe allergic reactions to other vaccines, foods, or medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean value (GMT or GMC) of Serum gE-specific IgG antibody and VZV antibody
Timeframe: Up to Day 90 (30 days after the last dose)
2
Geometric Mean Increase versus Postbaseline/Baseline Ab Titers
Timeframe: Up to Day 90 (30 days after the last dose)
3
gE-specific T cell responses
Timeframe: Up to Day 90 (30 days after the last dose)
. 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.