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A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19

A Double-blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2- Mediated COVID-19 in Participants Aged 12 Years and Older

NCT04672395•Clover Biopharmaceuticals AUS Pty

View on ClinicalTrials.gov

Summary

The purpose of this double-blind, randomized, controlled study is to evaluate the efficacy, immunogenicity, reactogenicity and safety of an adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) trimeric spike (S)-protein subunit vaccine (SCB-2019) for the prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 12 Years and Older.

Detailed Description

This study will assess the efficacy against COVID-19, immunogenicity, reactogenicity, and safety of CpG 1018/Alum-adjuvated SCB-2019 vaccine. The COVID-19 pandemic has resulted in high morbidity and mortality, caused major disruption to healthcare systems, and has had significant socioeconomic impacts. Currently, only limited treatment options are available against COVID-19 and accelerated vaccine development is urgently needed. Several COVID-19 vaccines were recently authorized in some countries, but the global supply is insufficient for pandemic control. Additional safe and effective vaccines for COVID-19 prevention would have significant public health impact. Placebo recipients will be offered two doses of SCB-2019 vaccine at defined points as part of the study. Adults participants who received SCB-2019 vaccine, will be given a third dose of the SCB-2019 vaccine at least 4 months after the second dose to assess the safety and efficacy of a booster (third) dose.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or females ≥12 years of age, inclusive\*.
•2. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, the electronic completion of the COVID-19 ePRO and other study procedures.
•3. Healthy adult or adolescent subjects or adult or adolescent subjects with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
•\*Note: The first 200 individuals enrolled in the Phase 2 part of the study should be healthy subjects 18 to 64 years or age without comorbidities associated with a high risk of severe COVID-19
•4. Female subjects who are WOCBP are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
•* WOCBP must have a negative urine pregnancy test prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the investigator's discretion.
•* They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the second vaccination.
•5. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period.
•6. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening. For adolescent subjects: informed assent signed by adolescents and informed consent signed by the parent(s) or legally acceptable representative(s) as per local requirements.
•7. Applicable for HIV-positive individuals only if:
+1 more criteria

Exclusion Criteria

•1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR\* or Rapid COVID-19 Antigen test) at screening or within 14 days prior to enrollment.
•2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the investigator.
•3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
•4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period.
•5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.
•6. Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine (SCB-2019, CpG1018 Adjuvant and Aluminum hydroxide components).
•7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
•8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.
•9. Individuals who have received previous vaccination with any coronavirus vaccine.
•10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination.
+4 more criteria

Locations (31)

Anima

Alken, Belgium

Hôspital Erasme

Brussels, Belgium

Private Practice RESPISOM Namur

Namur, Belgium

Instituto D'OR de Pesquisa e Ensino

Rio de Janeiro, Rio Do Janeiro, Brazil

Instituto Atena de Pesquisa Clinica

Natal, Rio Grande do Norte, Brazil

CPCLIN - Centro de Pesquisas Clínicas de Natal

Natal, Rio Grande do Norte, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital da Universidade Federal de Santa Maria CEP/UFSM

Santa Maria, Rio Grande do Sul, Brazil

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Acacias

Acacías, Colombia

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede Aguazul

Aguazul, Colombia

Key Dates

Start Date

March 24, 2021

Primary Completion Date

September 15, 2022

Completion Date

April 23, 2023

Last Updated

June 29, 2023

Enrollment

31,454

ACTUAL participants

Conditions

COVID-19

Interventions

CpG 1018/Alum-adjuvanted SCB-2019 vaccine

BIOLOGICAL

Placebo; 0.9% saline

BIOLOGICAL

SCB-2019 vaccine

BIOLOGICAL

SCB-2019 vaccine for Placebo

BIOLOGICAL

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

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NCT07221162

COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19

Inclusion Criteria

Exclusion Criteria

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