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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

PHRR210209-003334

CLO-SCB-2019-003

2020-CT0576

A Double-Blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of AS03-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 18 years and Older

Protocol Number: CLO-SCB-2019-003

This study will assess the efficacy against COVID-19 and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, immunogenicity, reactogenicity, and safety of AS03-adjvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine, SCB-2019. 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. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.

CLO-SCB-2019-003 is a double-blind, randomized, controlled, multi-country study of AS03-adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), to assess the efficacy, immunogenicity, reactogenicity, and safety compared with control (placebo). The study will include subjects aged 18 years and older:

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-03-01 24 2023-03-01 0000-00-00

Ongoing

Institution Classification Region LTO #
Clover Biopharmaceuticals AUS Pty Ltd Private Business None NAP
Institution Classification Region LTO #
IQVIA RDS Philippines, Inc. Private Business NCR LTO-3000005977146
Institution Region
Clover Biopharmaceuticals AUS Pty Ltd None
Name E-Mail Institution and Institution Address
Marissa Laureta marissa.laureta@iqvia.com IQVIA RDS Philippines Inc., Unit A 7th Floor, 8 Rockwell Bldg., Hidalgo Drive, Rockwell Center, Makati City
Name E-Mail Institution and Institution Address
Dr. Htay Htay Han htayhtay.han@cloverbiopharma.com CLOVER Pharmaceuticals AUS Pty.Ltd., Level 17, HWT Tower, 40 City Road Southbank VIC 3006, Australia
Name Expertise Affiliation
Camilo C. Roa Jr., MD Pulmonologist Manila Doctors Hospital
Charissa Fay C. Borja-Tabora, MD Infectious Disease Asian Hospital and Medical Center
Charles Y. Yu, MD, MSc Infectious Disease De La Salle Medical and Health Sciences Institute
Edison Reyes Alberto, MD Infectious Diseases Tropical Disease Foundation, Inc.
Josefina B. Cadorna-Carlos, MD Infectious Diseases University of the East Ramon Magsaysay Memorial Medical Center
Lulu C. Bravo, MD Infectious Diseases University of the Philippines, Manila
Mari Rose A. Delos Reyes, MD Infectious Diseases Las Pinas Doctors Hospital
Mario Panaligan Infectious Diseases St Luke Medical Center - Global City
May Emmeline Montellano, MD Infectious Diseases Far Eastern University-Nicanor Reyes Medical Foundation
Milagros S. Bautista, MD Infectious Diseases University of the East Ramon Magsaysay Memorial Medical Center
Project Location Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Asian Hospital and Medical Center Asian Hospital and Medical Center Institutional Review Board
De La Salle Medical and Health Sciences Institute N/A
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board
University of the East Ramon Magsaysay Memorial Medical Center N/A
University of the Philippines, Manila N/A
Las Pinas Doctors Hospital N/A
St Luke Medical Center - Global City N/A
Far Eastern University-Nicanor Reyes Medical Foundation N/A
University of the East Ramon Magsaysay Memorial Medical Center N/A

Healthy Individual

To demonstrate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of any laboratory-confirmed COVID-19 of any severity in subjects without evidence of prior SARS-CoV-2 infection.

To evaluate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of any laboratory-confirmed moderate-to-severe COVID-19 in subjects without evidence of prior SARS-CoV-2 infection.

To assess the safety and reactogenicity of AS03-adjuvanted SCB-2019 vaccine compared to placebo

To evaluate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of any laboratory-confirmed SARS-CoV-2 infection in subjects without evidence of prior SARS-CoV-2.

To evaluate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of any laboratory-confirmed severe COVID-19 in subjects without evidence of prior SARS-CoV-2 infection.

To evaluate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of any laboratory-confirmed asymptomatic SARS-CoV-2 infection in subjects without evidence of prior SARS-CoV-2 infection.

To evaluate the efficacy of AS03-adjuvanted SCB-2019 vaccine for the prevention of BOD, in subjects without evidence of prior SARS-CoV-2 infection

Pending

  • Philippines

Clinical Trial

CLO-SCB-2019-003

20201125102235

2020-01-08

0000-00-00

7700

Unspecified

Unspecified

01 Mar 2021

Inclusion Criteria Subjects are eligible to be included in the study only if all of the following criteria apply: Type of Subject 1. Male or females ≥18 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 adults or adults 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 Pregnancy and Contraception 4. Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply: • Women of childbearing potential (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. See Appendix 5 for definitions and details of acceptable methods of contraception. Informed Consent 5. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening.

Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply: 1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive result for the Rapid COVID-19 antigen test) or a known history of SARS-CoV-2 infection. 2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator.

Please refer to pages 52 - 53 of the protocol

Interventional

SCB-2019

CLO-SCB-2019-003 is a double-blind, randomized, controlled, multi-country study of AS03-adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), to assess the efficacy, immunogenicity, reactogenicity, and safety compared with control (placebo). The study will include subjects aged 18 years and older:

None

Unspecified

Unspecified

The randomization will be stratified by site, age group and absence/presence of comorbities that associated with a high risk of severe COVID-19. At least 25% of enrolled participants will at high risk of severed COVID-19.

Parallel

This study will assess the efficacy against COVID-19 and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, immunogenicity, reactogenicity, and safety of AS03-adjvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine, SCB-2019. 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. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.

Phase II/III

Utilization Utilization Info
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