Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

February 6, 2023 updated by: Wuhan BravoVax Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety in terms of adverse reactions/events
Time Frame: 30 mins, 0-7 days, 8-30 days and 0-30 days
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
Time Frame: 3 days after each vaccination
Incidence rates of abnormal laboratory indicators
3 days after each vaccination
Safety in terms of SAEs
Time Frame: Within 6 months after full vaccination
Incidence rates of SAEs
Within 6 months after full vaccination
Safety in terms of Adverse Events of Special Interest
Time Frame: Within 6 months after full vaccination
Incidence rates of AESI
Within 6 months after full vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunogencity in terms of GMT by ELISA or FAMA
Time Frame: Days 1, 30, 60, 90 and 240
GMC of anti-gE antibody and GMT of anti-VZV antibody
Days 1, 30, 60, 90 and 240
Immunogencity in terms of Seroconversion Rates
Time Frame: Days 30, 60, 90 and 240
Seroconversion rates of anti-gE and anti-VZV antibody responses
Days 30, 60, 90 and 240
Immunogencity in terms of Geometric Mean Fold Increase
Time Frame: Days 30, 60, 90 and 240
GMFI of anti-gE and anti-VZV antibody responses
Days 30, 60, 90 and 240
Immunogencity in terms of Cellular immunity
Time Frame: Days 1, 90 and 240
Frequency of CD4+ and CD8+T cells that express at least one cytokine
Days 1, 90 and 240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan BravoVax Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai BravoBio Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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