Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2023-08-17

Brief Summary

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The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SCB-2023 arm

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

Group Type EXPERIMENTAL

SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Intervention Type BIOLOGICAL

SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

SCB-2019 arm

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

Group Type ACTIVE_COMPARATOR

SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Intervention Type BIOLOGICAL

SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Interventions

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SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Intervention Type BIOLOGICAL

SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.
* Individuals who received three doses of inactivated COVID-19 vaccine.

Exclusion Criteria

* 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.
* Any progressive unstable or uncontrolled clinical conditions.
* Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
* History of severe adverse reaction associated with a vaccine or severe allergic reaction.
* History of malignancy within 1 year before screening.
* Individuals who have received any other investigational product.
* Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
* Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
* Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
* Administration of intravenous immunoglobulins and/or any blood products.
* Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes