Suspended

Monovalent Omicron XBB.1.5 Vaccine Booster for Previously Vaccinated Adults

What is being tested

SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19

+ SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19

Biological

Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3

Interventional

Study Start: October 2023

See protocol details

Summary

Principal SponsorClover Biopharmaceuticals AUS Pty

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2023

Actual date on which the first participant was enrolled.

This study aims to test a new COVID-19 booster shot specifically designed for the Omicron XBB.1.5 variant. It targets adults who have already received three doses of an inactivated COVID-19 vaccine at least six months ago. By comparing this new booster to an older version, the study seeks to determine how well it works in boosting the immune system and how safe it is for people to take. This research is important because it could lead to better protection against COVID-19 variants, addressing the ongoing challenge of keeping up with virus mutations. Participants in the study will receive the new Omicron XBB.1.5 vaccine as a booster shot, and the effects will be compared to those who receive the older vaccine. The study will measure how well the immune system responds to the new booster and monitor any side effects to ensure safety. This approach helps researchers understand the effectiveness and safety of updating vaccines to match new virus variants, which is essential for maintaining public health.

Official TitlePhase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine

NCT06567457

Principal SponsorClover Biopharmaceuticals AUS Pty

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

5 inclusion criteria required to participate

Male or female ≥18 years of age.

Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.

Individuals willing and able to give an informed consent, prior to screening.

Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.

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14 exclusion criteria prevent from participating

Body temperature >37.8°C (axillary), or any acute illness at baseline.

Confirmed SARS-CoV-2 infectionor with known history of COVID-19.

Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).

Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive one booster dose with SCB-2023B vaccine on Day 1

Group II

Active Comparator

Participants will receive one booster dose with SCB-2019 vaccine on Day 1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers