Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

Wuhan BravoVax

Status and phase: Not yet enrolling; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: Recombinant Zoster Vaccine; Biological: Placebo; Biological: Zoster Vaccine Recombinant, Adjuvanted

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05718037

BV-C211-202301

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 6 patient groups, including a placebo group

LY

Experimental group

Description:

Young adult subjects received low dose of BV211

Treatment:

Biological: Recombinant Zoster Vaccine

HY

Experimental group

Description:

Young adult subjects received high dose of BV211

Treatment:

Biological: Recombinant Zoster Vaccine

Placebo

Placebo Comparator group

Description:

Young adult subjects received placebo

Treatment:

Biological: Placebo

LO

Experimental group

Description:

Old adult subjects received low dose of BV211

Treatment:

Biological: Recombinant Zoster Vaccine

HO

Experimental group

Description:

Old adult subjects received high dose of BV211

Treatment:

Biological: Recombinant Zoster Vaccine

Control Vaccine

Active Comparator group

Description:

Old adult subjects received control vaccine

Treatment:

Biological: Zoster Vaccine Recombinant, Adjuvanted