Phase I Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above (NCT07285265) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above
China180 participantsStarted 2025-05-27
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
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 12 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:
✕. 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.
What they're measuring
1
Incidence of solicited AEs and ARs after each dose
Timeframe: up to day 74 (14 days after each dose)
2
Incidence of unsolicited AEs and ARs after each dose
✕. 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.