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New Generation mRNA Booster Vaccine Against Emerging VOCs

NCT05580159 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2023-04-12

No results posted yet for this study

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.

Conditions

  • Immunogenicity
  • Efficacy
  • Safety

Interventions

BIOLOGICAL

SW-BIC-213

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

BIOLOGICAL

SARS-Cov-2 Vaccina(Vero Cell ) Inactivated

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

Sponsors & Collaborators

  • Stemirna Therapeutics

    lead INDUSTRY

Principal Investigators

  • Mayfong Mayxay, doctor · National Ethics Committee for Health Research(NECHR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-05-11
Completion
2023-05-11

Countries

  • Laos

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580159 on ClinicalTrials.gov