New Generation mRNA Booster Vaccine Against Emerging VOCs

Summary: Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity 1. To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group. 2. To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group. Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
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Short title: New Generation mRNA Booster Vaccine Against Emerging VOCs
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Official title: A Multi-national, Randomized, Observer-blinded, Parallel Controlled Trial to Evaluate the Immunogenicity and Safety of New Generation COVID-19 mRNA Booster Vaccination Against Emerging Variants of Concern (VOC)
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Control arm: Active comparator
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Registry reports results: No
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Listing at source: Listed
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Recruitment status: Unknown
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Phase: Phase 3
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Study type: Interventional
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Completion date: 2023-05-11
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First posted: 2022-10-14
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Registry last updated: 2023-04-12
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Primary completion date: 2023-05-11
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Start date: 2022-10-01
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Participants: 2,000
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Participant count basis: Estimated
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Planned participants: 2,000
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Protocol amendments: 0
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Number of sites: 1
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Data monitoring committee: Yes
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Registry sponsor category: Industry
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Lead sponsor: Stemirna Therapeutics
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Source registry: ClinicalTrials.gov
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Registry ID: NCT05580159
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ClinicalTrials.gov ID: NCT05580159
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Registry record: Open registry record
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Allocation: Randomised
Model: Parallel groups
Purpose: Prevention
Masking: Quadruple masking
Masking description: This study uses a double blinded design, and the investigators and participants will all remain blinded before unblinding and do not know which group the participant belongs to.
Masked roles: Participants, Care providers, Investigators, Outcome assessors

Sources for study design

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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: 6 months post-dose
To describe the safety profile of all participants in each group up to 6 months post-dose.
Immunogenicity of 28 days post dose
Timeframe: 28 days post dose
To demonstrate the superiority of neutralizing antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine 28 days post dose.

Sources for outcomes

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Sex: All
Age groups: Adults, Older adults
Minimum age: 18 Years
Healthy volunteers: Yes

Participant is willing and able to give written informed consent for participation in the study.
Male or Female, aged 18 years or above and in good health as determined by study clinician.
Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunization continuously until 3 months after boost immunization.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Subjects had completed the 2-dose series vaccination of COVID-19 inactivated vaccine at least .

24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.

The participant may not enter the study if ANY of the following apply:

Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
Self-reported history of SARS and MERS infection;
Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination;
Receipt of any SARS-COV-2 vaccine after last dose of primary vaccination
Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
Any history of anaphylaxis to any component of vaccine.
Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
Suspected or known current alcohol or drug dependency
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness (mild/moderate well controlled comorbidities are allowed).
Scheduled elective surgery during the trial.