Herpes ZosterPhase 1NCT05718037
Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine
A Phase 1 study testing Recombinant Zoster Vaccine and Zoster Vaccine Recombinant, Adjuvanted in people with Herpes Zoster, run by Wuhan BravoVax Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Recombinant Zoster Vaccine and Zoster Vaccine Recombinant, Adjuvanted
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- Herpes Zoster
- Being tested
- Recombinant Zoster Vaccine, Placebo, Zoster Vaccine Recombinant, Adjuvanted
- Keywords
- Herpes Zoster Vaccine, BV211
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Zoster VaccineBiological
Also called BV211
0.5mL, Intramuscular
PlaceboBiological
0.5mL, Intramuscular
Zoster Vaccine Recombinant, AdjuvantedBiological
Also called Shingrix
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| LY | Experimental | Young adult subjects received low dose of BV211 Receives: Biological: Recombinant Zoster Vaccine |
| HY | Experimental | Young adult subjects received high dose of BV211 Receives: Biological: Recombinant Zoster Vaccine |
| Placebo | Placebo comparator | Young adult subjects received placebo Receives: Biological: Placebo |
| LO | Experimental | Old adult subjects received low dose of BV211 Receives: Biological: Recombinant Zoster Vaccine |
| HO | Experimental | Old adult subjects received high dose of BV211 Receives: Biological: Recombinant Zoster Vaccine |
| Control Vaccine | Active comparator | Old adult subjects received control vaccine Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of adverse reactions/events
Incidence rates of adverse reactions/events (ADRs/AEs)
Measured: 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
Measured: 3 days after each vaccination
Safety in terms of SAEs
Incidence rates of SAEs
Measured: Within 6 months after full vaccination
Safety in terms of Adverse Events of Special Interest
Incidence rates of AESI
Measured: Within 6 months after full vaccination
Secondary outcomes (4)
Immunogencity in terms of GMT by ELISA or FAMA
GMC of anti-gE antibody and GMT of anti-VZV antibody
Measured: Days 1, 30, 60, 90 and 240
Immunogencity in terms of Seroconversion Rates
Seroconversion rates of anti-gE and anti-VZV antibody responses
Measured: Days 30, 60, 90 and 240
Immunogencity in terms of Geometric Mean Fold Increase
GMFI of anti-gE and anti-VZV antibody responses
Measured: 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
Measured: Days 1, 90 and 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan BravoVax Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai BravoBio Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718037
- Sponsor's protocol ID
- BV-C211-202301
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers
- ClinicalTrials.gov ID
- NCT05718037
- Acronym / sponsor ID
- BV-C211-202301
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster Vaccine, BV211
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wuhan BravoVax Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai BravoBio Co., Ltd.
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY | Experimental | Biological: Recombinant Zoster VaccineYoung adult subjects received low dose of BV211 |
| HY | Experimental | Biological: Recombinant Zoster VaccineYoung adult subjects received high dose of BV211 |
| Placebo | Placebo comparator | Biological: PlaceboYoung adult subjects received placebo |
| LO | Experimental | Biological: Recombinant Zoster VaccineOld adult subjects received low dose of BV211 |
| HO | Experimental | Biological: Recombinant Zoster VaccineOld adult subjects received high dose of BV211 |
| Control Vaccine | Active comparator | Biological: Zoster Vaccine Recombinant, AdjuvantedOld adult subjects received control vaccine |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Zoster VaccineAlso: BV2110.5mL, Intramuscular | Biological | HO, HY, LO, LY |
| Placebo0.5mL, Intramuscular | Biological | Placebo |
| Zoster Vaccine Recombinant, AdjuvantedAlso: Shingrix0.5mL, Intramuscular | Biological | Control Vaccine |
Primary outcome
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)
Safety in terms of laboratory-based AEs
Time frame: 3 days after each vaccination
Incidence rates of abnormal laboratory indicators
Safety in terms of SAEs
Time frame: Within 6 months after full vaccination
Incidence rates of SAEs
Safety in terms of Adverse Events of Special Interest
Time frame: Within 6 months after full vaccination
Incidence rates of AESI
4 secondary outcomes
Immunogencity in terms of GMT by ELISA or FAMA
Time frame: Days 1, 30, 60, 90 and 240
Immunogencity in terms of Seroconversion Rates
Time frame: Days 30, 60, 90 and 240
Immunogencity in terms of Geometric Mean Fold Increase
Time frame: Days 30, 60, 90 and 240
Immunogencity in terms of Cellular immunity
Time frame: Days 1, 90 and 240
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Zoster Vaccine and Zoster Vaccine Recombinant, Adjuvanted in people with Herpes Zoster, run by Wuhan BravoVax Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in terms of adverse reactions/events (time frame: 30 mins, 0-7 days, 8-30 days and 0-30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.