Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: Placebo; Biological: Recombinant Zoster Vaccine; Biological: Zoster Vaccine Recombinant, Adjuvanted

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY; Young adult subjects received low dose of BV211	Biological: Recombinant Zoster Vaccine; 0.5mL, Intramuscular; Other Names: BV211
EXPERIMENTAL: HY; Young adult subjects received high dose of BV211	Biological: Recombinant Zoster Vaccine; 0.5mL, Intramuscular; Other Names: BV211
PLACEBO_COMPARATOR: Placebo; Young adult subjects received placebo	Biological: Placebo; 0.5mL, Intramuscular
EXPERIMENTAL: LO; Old adult subjects received low dose of BV211	Biological: Recombinant Zoster Vaccine; 0.5mL, Intramuscular; Other Names: BV211
EXPERIMENTAL: HO; Old adult subjects received high dose of BV211	Biological: Recombinant Zoster Vaccine; 0.5mL, Intramuscular; Other Names: BV211
ACTIVE_COMPARATOR: Control Vaccine; Old adult subjects received control vaccine	Biological: Zoster Vaccine Recombinant, Adjuvanted; 0.5mL, Intramuscular; Other Names: Shingrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in terms of adverse reactions/events	Incidence rates of adverse reactions/events (ADRs/AEs)	30 mins, 0-7 days, 8-30 days and 0-30 days
Safety in terms of laboratory-based AEs	Incidence rates of abnormal laboratory indicators	3 days after each vaccination
Safety in terms of SAEs	Incidence rates of SAEs	Within 6 months after full vaccination
Safety in terms of Adverse Events of Special Interest	Incidence rates of AESI	Within 6 months after full vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogencity in terms of GMT by ELISA or FAMA	GMC of anti-gE antibody and GMT of anti-VZV antibody	Days 1, 30, 60, 90 and 240
Immunogencity in terms of Seroconversion Rates	Seroconversion rates of anti-gE and anti-VZV antibody responses	Days 30, 60, 90 and 240
Immunogencity in terms of Geometric Mean Fold Increase	GMFI of anti-gE and anti-VZV antibody responses	Days 30, 60, 90 and 240
Immunogencity in terms of Cellular immunity	Frequency of CD4+ and CD8+T cells that express at least one cytokine	Days 1, 90 and 240

Collaborators and Investigators

• Sponsor: Wuhan BravoVax Co., Ltd.
• Collaborators: Shanghai BravoBio Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2023
• Primary Completion (ANTICIPATED): January 31, 2024
• Study Completion (ANTICIPATED): July 31, 2024

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Herpes Zoster Vaccine; BV211
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BV-C211-202301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No