A study to evaluate an mRNA COVID-19 vaccine (IN002.5.1) in comparison with an approved mRNA COVID-19 vaccine
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
Shenzhen Shenxin Biotechnology Co., Ltd.
60 participants
Apr 28, 2023
Interventional
Conditions
Summary
IN002.5.1 is a potential new mRNA COVID-19 booster vaccination which will be compared to a comparator vaccine, Moderna. The purpose of this study is to evaluate how safe and well tolerated IN002.5.1 is compared to Moderna, in previously vaccinated participants. Meanwhile the study is to measure the body’s response to a single dose of IN002.5.1, and assess how strong the body’s immune response to IN002.5.1 in previously vaccinated participants.
Eligibility
Inclusion Criteria9
- Male or female, >=18 and <= 59 years of age.
- 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.
- Participants with Gilbert’s syndrome who have normal conjugated bilirubin and normal liver function tests (LFTs).
- Participants must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) COVID-19 vaccine.
- Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test and they are not breastfeeding.
- Sexually active non-sterile male subjects must be willing to use an acceptable contraceptive method throughout the study.
- Female subjects of childbearing potential must be willing not to donate eggs from dosing until the EOS.
- Male subjects must be willing not to donate sperm from dosing until the EOS.
- 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.
Exclusion Criteria22
- Any clinically significant abnormal finding at physical examination.
- 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
- 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.
- 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.
- Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
- 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.
- 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.
- Previous participation in other studies involving study intervention with lipid nanoparticles (LNPs).
- Positive pregnancy test or lactating female subject.
- Positive urine drug screen or alcohol breath test.
- History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug or vaccine, or any excipients in the formulation.
- 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.
- 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.
- 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.
- 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).
- 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.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
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Interventions
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.
Locations(1)
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ACTRN12622001415796