Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

NCT05718037 | Unknown Phase 1

• 1 other identifier: BV-C211-202301
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Zoster

Keywords

Herpes Zoster Vaccine; BV211

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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 Geometric Mean Fold Increase

  Days 30, 60, 90 and 240

• Immunogencity in terms of Cellular immunity

  Days 1, 90 and 240

Study Arms (6)

LY

EXPERIMENTAL

Young adult subjects received low dose of BV211

Biological: Recombinant Zoster Vaccine

HY

EXPERIMENTAL

Young adult subjects received high dose of BV211

Biological: Recombinant Zoster Vaccine

Placebo

PLACEBO COMPARATOR

Young adult subjects received placebo

Biological: Placebo

LO

EXPERIMENTAL

Old adult subjects received low dose of BV211

Biological: Recombinant Zoster Vaccine

HO

EXPERIMENTAL

Old adult subjects received high dose of BV211

Biological: Recombinant Zoster Vaccine

Control Vaccine

ACTIVE COMPARATOR

Old adult subjects received control vaccine

Biological: Zoster Vaccine Recombinant, Adjuvanted

Interventions

Recombinant Zoster Vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: BV211

HO; HY; LO; LY

Placebo BIOLOGICAL

0.5mL, Intramuscular

Placebo

Zoster Vaccine Recombinant, Adjuvanted BIOLOGICAL

0.5mL, Intramuscular

Also known as: Shingrix

Control Vaccine

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan BravoVax Co., Ltd.: lead
• Shanghai BravoBio Co., Ltd.: collaborator

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: August 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01