Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05718037
• Other study ID #: BV-C211-202301
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2023
• Source: Wuhan BravoVax Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Zoster

Intervention

Biological:
• Recombinant Zoster Vaccine
0.5mL, Intramuscular
• Placebo
0.5mL, Intramuscular
• Zoster Vaccine Recombinant, Adjuvanted
0.5mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan BravoVax Co., Ltd.	Shanghai BravoBio Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety in terms of laboratory-based AEs	Incidence rates of abnormal laboratory indicators	3 days after each vaccination
Primary	Safety in terms of SAEs	Incidence rates of SAEs	Within 6 months after full vaccination
Primary	Safety in terms of Adverse Events of Special Interest	Incidence rates of AESI	Within 6 months after full vaccination
Secondary	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
Secondary	Immunogencity in terms of Seroconversion Rates	Seroconversion rates of anti-gE and anti-VZV antibody responses	Days 30, 60, 90 and 240
Secondary	Immunogencity in terms of Geometric Mean Fold Increase	GMFI of anti-gE and anti-VZV antibody responses	Days 30, 60, 90 and 240
Secondary	Immunogencity in terms of Cellular immunity	Frequency of CD4+ and CD8+T cells that express at least one cytokine	Days 1, 90 and 240