Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001415796
Ethics application status
Approved
Date submitted
2/11/2022
Date registered
7/11/2022
Date last updated
13/10/2024
Date data sharing statement initially provided
7/11/2022
Date results provided
13/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate an mRNA COVID-19 vaccine (IN002.5.1) in comparison with an approved mRNA COVID-19 vaccine
Scientific title
A randomized, double-blind, active-controlled, phase I clinical study to evaluate the safety, tolerability, and immunogenicity of a COVID-19 mRNA vaccine (in002.5.1) in comparison with an approved mRNA booster vaccine for COVID-19 in population >= 18 years of age
Secondary ID [1] 308224 0
Protocol IN002011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 327986 0
Condition category
Condition code
Infection 325043 325043 0 0
Other infectious diseases
Respiratory 325187 325187 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase 1, randomized, double-blind, active controlled, staggered, dose-escalation study, consisting of 2 cohorts to evaluate the safety, tolerability and immunogenicity of an intramuscular injection COVID-19 mRNA vaccine in healthy subjects who had previously received either two or three doses of the approved/authorized mRNA COVID-19 vaccine (Moderna). The study will consist of 2 cohorts (1 cohort per dose level). Each cohort will include 30 subjects for a total of 60 subjects.

A staggered dosing schedule will be used for dosing and will include 6 sentinel subjects in each cohort. Initially, 2 sentinels will receive IN002.5.1 and 1 will receive Moderna vaccine and the remaining sentinels will be vaccinated 3 days later in a 2:1 ratio (2 receiving IN002.5.1 and 1 receiving active control vaccine). In Cohort 1, the remaining 24 subjects will be dosed at least 7 days later, following review of sentinels’ safety and tolerability data through e-mail by a Safety Review Committee (SRC).Based on the SRC’s recommendations, the study will progress towards the vaccination of the remaining subjects in that cohort.

Based on the SRC’s recommendations, the study will progress towards the vaccination of the remaining subjects in that cohort, as well as subjects in the subsequently planned cohort.
The planned dose range is anticipated to be as follows:
• Cohort 1: single dose of 30 µg administered on Day 1 (formulation IN002.5.1) or 50 µg dose of active control vaccine.
• Cohort 2: single dose of 60 µg administered on Day 1 (formulation IN002.5.1) or 50 µg dose of active control vaccine.

The SRC will review the safety and tolerability data for the 24 subjects in Cohort 1 for up to 15 days through a formal meeting, in order to make decisions whether to continue vaccination of the remaining subjects in Cohort 2. The decision can be to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.

The pharmacist at site will be unblinded and will prepare the study drug. The trained nurse will perform administration. The procedure will observed and recorded by a member of study team.
Intervention code [1] 324686 0
Prevention
Comparator / control treatment
Control group will receive 1 dose Moderna vaccine
Control group
Active

Outcomes
Primary outcome [1] 332866 0
To evaluate the safety and tolerability of IN002.5.1 as a booster vaccine following IM administration in healthy subjects >= 18 years of age by assessing adverse event (AE) percentage of the booster vaccine.
Subjects will be monitored throughout the study by the clinical staff for AEs. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the investigational product, whether or not considered related to the investigational product.
A diary will be provided to subject to record local reactions, daily temperatures and other adverse event. The diary will be reviewed by the Investigator and the clinicians during the study. Meanwhile adequate medical surveillance will be assured during the confinement period and the Investigator or designee will be available on call at all times. If necessary, the Investigator or designee at the clinical site or a healthcare professional in a nearby hospital will administer treatment for any AE(s).
Timepoint [1] 332866 0
1. The occurrence of immediate AEs (time frame: 30 minutes after administration on Day 1); 2. Solicited local AE (time frame: 14 days after administration); 3. Solicited systemic AE (time frame: 14 days after administration); 4. Unsolicited AEs (time frame: 28 days after administration); 5. Serious Adverse Events (SAEs) (time frame: 6 months after administration); 6. Adverse events of special interest (AESIs) (time frame: 6 months after administration).
Primary outcome [2] 332867 0
To evaluate the immunogenicity of IN002.5.1 as a booster vaccine following IM administration in healthy subjects >= 18 years of age by assessing humoral response, using blood sample.
Timepoint [2] 332867 0
Humoral response on Day 29 after administration;
Primary outcome [3] 333015 0
To evaluate the immunogenicity of IN002.5.1 as a booster vaccine following IM administration in healthy subjects >= 18 years of age by assessing cell-mediated immunogenicity (CMI) response, using blood sample.
Timepoint [3] 333015 0
Cell-mediated immunogenicity (CMI) response in the specific cellular immunogenicity subgroup at Day 8, Day 29 after administration.
Secondary outcome [1] 414899 0
To evaluate the sustainability of immune-response of IN002.5.1 as a booster vaccine in healthy subjects >= 18 years of age by assessing humoral response, using blood sample.
Timepoint [1] 414899 0
Humoral response at 3 months and 6 months after administration.
Secondary outcome [2] 415553 0
To evaluate the sustainability of immune-response of IN002.5.1 as a booster vaccine in healthy subjects >= 18 years of age by asseesing cell-mediated immunogenicity (CMI) response, using blood sample.
Timepoint [2] 415553 0
CMI response in the specific cellular immunogenicity subgroup at 3 months and 6 months after administration.

Eligibility
Key inclusion criteria
1. Male or female, >=18 and <= 59 years of age.
2. Body mass index (BMI) > 18.5 and < 35.0 kg/m2 and body weight >= 50.0 kg for males and >= 45.0 kg for females.
3. Participants with Gilbert’s syndrome who have normal conjugated bilirubin and normal liver function tests (LFTs).
4. Participants must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) COVID-19 vaccine.
5. Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test and they are not breastfeeding.
6. Sexually active non-sterile male subjects must be willing to use an acceptable contraceptive method throughout the study.
7. Female subjects of childbearing potential must be willing not to donate eggs from dosing until the EOS.
8. Male subjects must be willing not to donate sperm from dosing until the EOS.
9. Participants who provide signed informed consent to participate in the study and are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination.
2. Subjects with any of the following laboratory abnormalities at Screening:
a. Alanine aminotransferase (ALT) > 1.5X upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) > 1.5X ULN
c. Alkaline phosphatase > 1.5X ULN
d. Total Bilirubin > 2X ULN
e. Neutrophils < 1.5 x 109/µL or < 1.0 x 109/µL in African Americans or black subjects
3. Participants had close contact (without personal protective equipment [PPE]) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
4. Participant has tested positive for SARS-CoV-2 by an authorized/approved lateral flow/rapid antigen or polymerase chain reaction (PCR) test within 90 days of Screening.
5. Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
6. Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
7. Participant has dosed in an interventional clinical study within 90 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
8. Previous participation in other studies involving study intervention with lipid nanoparticles (LNPs).
9. Positive pregnancy test or lactating female subject.
10. Positive urine drug screen or alcohol breath test.
11. History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug or vaccine, or any excipients in the formulation.
12. Clinically significant electrocardiogram (ECG) abnormalities or vital signs abnormalities (systolic blood pressure (BP) lower than 85 or over 150 mmHg, diastolic BP lower than 50 or over 90 mmHg, heart rate (HR) less than 40 or over 100 bpm, or respiratory rate (RR) less than 8 or over 22 bpm) at screening.
13. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (e.g., due to enterovirus or adenovirus), and celiac disease.
14. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
15. History of a known or suspected respiratory system disorder including, but not limited to, cystic fibrosis, interstitial lung disease, reactive airway disease, emphysema, chronic bronchitis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), or asthma (participants with childhood asthma can be included in the study).
16. Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the injection site which, in the opinion of the Investigator, may inhibit the ability to effectively perform an injection site assessment.
17. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2023
Actual
28/04/2023
Date of last participant enrolment
Anticipated
Actual
17/08/2023
Date of last data collection
Anticipated
13/02/2024
Actual
16/02/2024
Sample size
Target
60
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 25071 0
New Zealand
State/province [1] 25071 0

Funding & Sponsors
Funding source category [1] 312479 0
Commercial sector/Industry
Name [1] 312479 0
Shenzhen Shenxin Biotechnology Co., Ltd.
Country [1] 312479 0
China
Primary sponsor type
Commercial sector/Industry
Name
Shenzhen Shenxin Biotechnology Co., Ltd.
Address
6th Floor of Building B, Tsinghua Information Harbor, No.1, SongpingShan New East Road, SongpingShan Community, Xili Street, Nanshan District, Shenzhen, Guangdong, China, 518055
Country
China
Secondary sponsor category [1] 314065 0
None
Name [1] 314065 0
Address [1] 314065 0
Country [1] 314065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311821 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 311821 0
Ethics committee country [1] 311821 0
New Zealand
Date submitted for ethics approval [1] 311821 0
03/03/2023
Approval date [1] 311821 0
16/03/2023
Ethics approval number [1] 311821 0
2023 AM 13608

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122486 0
Dr Cory Sellwood
Address 122486 0
New Zealand Clinical Research (NZCR), Ground Floor 3, Ferncroft St, Grafton, Auckland 1010, New Zealand
Country 122486 0
New Zealand
Phone 122486 0
+64 21 461766
Fax 122486 0
Email 122486 0
[email protected]
Contact person for public queries
Name 122487 0
Yinrui Jiang
Address 122487 0
Shenzhen Shenxin Biotechnology Co., Ltd., 6th Floor of Building B, Tsinghua Information Harbor, No.1, SongpingShan New East Road, SongpingShan Community, Xili Street, Nanshan District, Shenzhen, Guangdong, China, 518055
Country 122487 0
China
Phone 122487 0
+86 755 86533681
Fax 122487 0
Email 122487 0
[email protected]
Contact person for scientific queries
Name 122488 0
Yinrui Jiang
Address 122488 0
Shenzhen Shenxin Biotechnology Co., Ltd., 6th Floor of Building B, Tsinghua Information Harbor, No.1, SongpingShan New East Road, SongpingShan Community, Xili Street, Nanshan District, Shenzhen, Guangdong, China, 518055
Country 122488 0
China
Phone 122488 0
+86 755 86533681
Fax 122488 0
Email 122488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.