New Generation mRNA Booster Vaccine Against Emerging VOCs

NCT05580159 | Unknown Phase 3 DMC

• 1 other identifier: SWC310
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
2. 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.

Conditions

Immunogenicity; Efficacy; Safety

Keywords

new generation mRNA vaccine

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  To describe the safety profile of all participants in each group up to 6 months post-dose.

  6 months post-dose

• Immunogenicity of 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.

  28 days post dose

Study Arms (2)

SW-BIC-213

EXPERIMENTAL

Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular

Biological: SW-BIC-213

SARS-Cov-2 Vaccina(Vero Cell ) Inactivated

ACTIVE COMPARATOR

Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration Intramuscular : injection Intramuscular

Biological: SARS-Cov-2 Vaccina(Vero Cell ) Inactivated

Interventions

SW-BIC-213 BIOLOGICAL

The patient will take a single 25 μg dose mRNA vaccine SW-BIC-213.

SW-BIC-213

SARS-Cov-2 Vaccina(Vero Cell ) Inactivated BIOLOGICAL

The patient will take a third dose of COVID-19 Inactivated vaccine.

SARS-Cov-2 Vaccina(Vero Cell ) Inactivated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stemirna Therapeutics: lead

Study Sites (1)

Savannakhét Provincial hospital

Savannakhet, Sava, Laos

RECRUITING

Related Publications (1)

• Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372. doi: 10.1016/j.eclinm.2023.102372. eCollection 2024 Jan.

  PMID: 38169790 DERIVED

Study Officials

• Mayfong Mayxay, doctor

  National Ethics Committee for Health Research(NECHR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yang li, doctor

CONTACT

+856 02095779465; yang.li@stemirna.com

bin luo, bachelor

CONTACT

+856 02095779465; bin.luo@stemirna.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a randomized observer-blinded parallel controlled trial：Experimental group（mRNA vaccine） and positive control group（inactive vaccine）

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 14, 2022
• Study Start: October 1, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)