NCT05718037
Not yet recruiting
Phase 1
A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers
ConditionsHerpes Zoster
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Herpes Zoster
- Sponsor
- Wuhan BravoVax Co., Ltd.
- Enrollment
- 40
- Primary Endpoint
- Safety in terms of adverse reactions/events
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy resident aged 30-70 years with body weight ≥ 50 kg for males and ≥ 45 kg for females, BMI within the range of 19.0-32.0 (including the boundary value), who can provide legal identification.
- •Willing to participate in the study and sign ICF.
- •Women of childbearing age shall take effective contraception measures 30 days before vaccination up to 6 months post full vaccination and not in lactation period. The pregnancy test on the day of vaccination shall be negative.
- •Will attend all scheduled follow-up visits and follow the requirements of the clinical study.
Exclusion Criteria
- •Smoking, and/or excessive alcohol use.
- •Failed the screening test of illicit drugs, including THC.
- •Axillary temperature above 37.3℃.
- •History of herpes zoster.
- •Received any herpes zoster vaccine.
- •Received any vaccine within 14 days or live vaccine within 28 days before vaccination.
- •Received gamma immunoglobulin or intravenous immunoglobulin within 3 months before vaccination.
- •Have acute illness or are in the acute exacerbation phase of a chronic disease within 3 days before vaccination.
- •Allergic history to any vaccine-related component; history of severe allergies to any vaccine.
- •History of convulsions, epilepsy or encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, damage to nerve tissue in brain caused by chemical drug poisoning, etc.) and psychiatric history or family history of mental illness.
Outcomes
Primary Outcomes
Safety in terms of adverse reactions/events
Time Frame: 30 mins, 0-7 days, 8-30 days and 0-30 days
Incidence rates of adverse reactions/events (ADRs/AEs)
Safety in terms of laboratory-based AEs
Time Frame: 3 days after each vaccination
Incidence rates of abnormal laboratory indicators
Safety in terms of Adverse Events of Special Interest
Time Frame: Within 6 months after full vaccination
Incidence rates of AESI
Safety in terms of SAEs
Time Frame: Within 6 months after full vaccination
Incidence rates of SAEs
Secondary Outcomes
- Immunogencity in terms of GMT by ELISA or FAMA(Days 1, 30, 60, 90 and 240)
- Immunogencity in terms of Seroconversion Rates(Days 30, 60, 90 and 240)
- Immunogencity in terms of Cellular immunity(Days 1, 90 and 240)
- Immunogencity in terms of Geometric Mean Fold Increase(Days 30, 60, 90 and 240)
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