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.
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.
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;
Parallel
ABO1108
Biological/VaccineFormulation for injection
Placebo
Drug0.9% sodium chloride (normal saline) injection
Confirmed herpes zoster incidence rate per person-year]
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Suzhou Abogen Biosciences Co., Ltd.
Lead sponsor
Abogen Biosciences (Shanghai) Co., Ltd
Collaborator
