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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06335849




Registration number
NCT06335849
Ethics application status
Date submitted
13/03/2024
Date registered
28/03/2024
Date last updated
30/05/2024

Titles & IDs
Public title
A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years
Scientific title
A Phase I, Randomized, Observer-blinded, Positive-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years
Secondary ID [1] 0 0
LYB004-CT-AUS-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - LYB004 25µg
Other interventions - LYB004 50µg
Other interventions - SHINGRIX

Experimental: Treatment 1 (LYB004 25µg) - Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Experimental: Treatment 2 (LYB004 50µg) - Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Active Comparator: Treatment 3 (SHINGRIX) - Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.


Other interventions: LYB004 25µg
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Other interventions: LYB004 50µg
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Other interventions: SHINGRIX
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 µg LYB004, 50 µg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the reactogenicity of LYB004 vaccine
Timepoint [1] 0 0
Within 30 minutes after each vaccination
Primary outcome [2] 0 0
Evaluate the safety and reactogenicity of LYB004 vaccine
Timepoint [2] 0 0
Within 0-7 days after each vaccination
Primary outcome [3] 0 0
Evaluate the safety of LYB004 vaccine
Timepoint [3] 0 0
Within 8-30 days after each vaccination
Primary outcome [4] 0 0
Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine
Timepoint [4] 0 0
3 days, 14 days after each vaccination and 90 days after the first vaccination
Primary outcome [5] 0 0
Evaluate the SAEs and AESIs of LYB004 vaccine
Timepoint [5] 0 0
From the first vaccination up to 6 months after the second vaccination
Secondary outcome [1] 0 0
Observe the humoral immunity of LYB004 vaccine
Timepoint [1] 0 0
At 14 and 30 days after each vaccination
Secondary outcome [2] 0 0
Observe the cellular immunity of LYB004 vaccine
Timepoint [2] 0 0
At 30 days after the second vaccination
Secondary outcome [3] 0 0
Observe the persistence of humoral immunity of LYB004 vaccine
Timepoint [3] 0 0
At 6 months after full vaccination
Secondary outcome [4] 0 0
Observe the persistence of cellular immunity of LYB004 vaccine
Timepoint [4] 0 0
At 6 months after full vaccination

Eligibility
Key inclusion criteria
1. A male or female aged 50 to 70 years inclusive at screening.

2. Written informed consent obtained from the subject before any assessment is performed.

3. Subjects who the investigator believes that they can and will comply with the
requirements of the protocol. (e.g., complete the diary cards, and complete follow-up
visits).

4. Subjects must have a Body Mass Index (BMI) between =18.0 and =35.0 kg/m^2 at
screening.

5. Female subjects who are not pregnant or lactating. Female subjects with childbearing
potential and their partners should use highly effective, medically accepted
double-barrier contraception and will not have pregnancy and fertility plan until
study completion.

- Female subjects of childbearing potential are defined as sexually mature women:
1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral
oophorectomy; 2) have had natural menses at any time in the preceding 12
consecutive months (without an alternative medical cause).

- Highly effective double-barrier contraception is defined as use of a condom AND
one of the following: Birth control pills (The Pill), Depot or injectable birth
control, Intrauterine device (IUD), Birth Control Patch (e.g., Ortho Evra),
NuvaRing®, Implantable contraception (e.g., Implanon).

6. Males participating in this study must agree to use highly effective, medically
accepted double-barrier contraception (as described above) and refrain from donating
sperm until study completion.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Tympanic temperature > 37.5°C at screening.

2. History of HZ.

3. Previous vaccination against HZ or varicella. Planned administration of VZV or HZ
vaccination during the study (including an investigational or non-registered vaccine),
except for the investigational vaccine.

4. Received a live attenuated vaccine within 28 days before vaccination or received other
vaccines within 14 days before vaccination.

5. Received any immunoglobulins or blood/plasma products within 3 months prior to
vaccination.

6. Individuals with the following diseases: 1)Any acute disease or acute attack of
chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g.,
acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior
to enrolment; 2)Allergies to any component of the investigational vaccine; 3)Subject
has any clinically significant history of allergic conditions to other vaccines.
4)History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or
psychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the participant inappropriate for entry into this study;
5)Asplenia, or functional asplenia; 6)Congenital or acquired immunodeficiency or
autoimmune disease; 7)Chronic administration (=14 consecutive days) of glucocorticoid
(reference value for dose: =20 mg/day prednisone or equivalent) or other
immunosuppressive agents within the past 3 months, with the exception of inhaled or
topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids;
8)Has severe cardiovascular diseases (cardiopulmonary disease, pulmonary edema),
severe hepatic or renal diseases, and diabetes complications that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the participant inappropriate for entry into this study;
9)History of thrombocytopenia or other coagulation disorders which may be
contraindications for an IM; 10)Severe hypertension uncontrolled by medication with
systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg;
11)Positive test for Hepatitis C virus (HCV), Hepatitis B surface antigen (HbsAg),
Human immunodeficiency virus (HIV) at screening; 12)Any skin condition and/or tattoo
that may interfere with the evaluation of safety at the injection site.

7. Clinically significant laboratory abnormalities determined by the investigator prior
to vaccination.

8. A positive urine drug test or alcohol breath test or a history of drug or alcohol
abuse in the past 1 years.

9. Recent participation in another clinical trial, with receipt of the investigational
drug/vaccine within 30 days prior to screening. Current participation or those
planning to participate in another clinical trial during the study.

10. Other conditions that may impact the subject's safety or influence the assessment of
vaccine response, as determined by the investigator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Guangzhou Patronus Biotech Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Yantai Patronus Biotech Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase 1 study in Australia will evaluate the safety and immunogenicity of the
Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06335849
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Chang, M.D
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherine Gunn
Address 0 0
Country 0 0
Phone 0 0
0737072781
Fax 0 0
Email 0 0
k.gunn@nucleusnetwork.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06335849