Clinical trial NCT05718037: Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine
Official title: A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Herpes Zoster
Keywords: Herpes Zoster Vaccine
BV211
Lead sponsor: Wuhan BravoVax Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai BravoBio Co., Ltd.
First posted: 2023-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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.
* Asplenia or functional asplenia, and asplenia or splenectomy caused by any reason.
* Primary or secondary immunocompromised or diagnosed with congenital or acquired immunodeficiency, infection of HIV, lymphoma, leukemia, SLE, JRA, inflammatory bowel disease or other autoimmune diseases.
* Received immunosuppressive therapy (such as long-term application of systemic glucocorticoids ≥ 14 days, dose ≥ 2 mg/kg/day or prednisone ≥ 20mg/day or equivalent to that dose of prednisone, excluding inhaled, intra-articular and topical steroid) within 3 months before vaccination.
* Serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), liver and renal diseases and diabetes with complications.
* History of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection.
* Abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) before vaccination; abnormal ECG
* Laboratory indicators out of the specified ranges (i.e., out of 1.5x of ULN or LLN), or with clinical significance as judged by the physician.
* Current/long-term history of alcohol abuse and/or history of drug abuse.
* Any other factors judged by investigator that may affect the safety of the subject or evaluation of the study.

Primary outcomes:
measure: Safety in terms of adverse reactions/events
timeFrame: 30 mins, 0-7 days, 8-30 days and 0-30 days
measure: Safety in terms of laboratory-based AEs
timeFrame: 3 days after each vaccination
measure: Safety in terms of SAEs
timeFrame: Within 6 months after full vaccination
measure: Safety in terms of Adverse Events of Special Interest
timeFrame: Within 6 months after full vaccination
Secondary outcomes:
measure: Immunogencity in terms of GMT by ELISA or FAMA
timeFrame: Days 1, 30, 60, 90 and 240
measure: Immunogencity in terms of Seroconversion Rates
timeFrame: Days 30, 60, 90 and 240
measure: Immunogencity in terms of Geometric Mean Fold Increase
timeFrame: Days 30, 60, 90 and 240
measure: Immunogencity in terms of Cellular immunity
timeFrame: Days 1, 90 and 240
Other outcomes:
Locations:
Study officials:
References: