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

NCT04672395 | Completed Phase 2 DMC

• 1 other identifier: CLO-SCB-2019-003
• Study Type: interventional
• Target: 31,454
• Locations: 5 countries
• Sites: 31

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019

  Day 36 up to Day 389 (1 year after second dose)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 8 (7 days after first dose) and up to Day 29 (7 days after second dose)

• Number of Participants with Unsolicited AEs

  Up to Day 43 (21 days after each dose)

• Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)

  Up to Day 389 (1 year after second dose)

• Non-inferiority of the neutralizing titers after third dose compared to the neutralizing titers after second dose

  14 days after third dose

• Non-inferiority of the neutralising titers in adolescents versus young adults.

  14 days after second dose

Secondary Outcomes (30)

• Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019

  Day 36 up to Day 389 (1 year after second dose)

• Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo

  Day 36 up to Day 389 (1 year after second dose)

• Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo

  Day 36 up to Day 389 (1 year after second dose)

• Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo

  Day 36 up to Day 389 (1 year after second dose)

• Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo

  Day 36 up to Day 389 (1 year after second dose)

Study Arms (4)

Group 1

EXPERIMENTAL

CpG 1018/Alum-adjuvanted SCB-2019 vaccine

Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine

Group 2

PLACEBO COMPARATOR

Placebo Comparator: 0.9% Saline

Biological: Placebo; 0.9% saline

Booster dose of SCB-2019

EXPERIMENTAL

Adult SCB-2019 recipients will receive 1 dose of SCB-2019 at least 4 months after the second dose

Biological: SCB-2019 vaccine

Vaccination of placebo recipients with SCB-2019

PLACEBO COMPARATOR

Placebo participants will be offered two doses of SCB-2019 vaccine

Biological: SCB-2019 vaccine for Placebo

Interventions

CpG 1018/Alum-adjuvanted SCB-2019 vaccine BIOLOGICAL

Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG1018/Alum adjuvant on Day 1 and on Day 22

Group 1

Placebo; 0.9% saline BIOLOGICAL

Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22

Group 2

SCB-2019 vaccine BIOLOGICAL

Participants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant

Booster dose of SCB-2019

SCB-2019 vaccine for Placebo BIOLOGICAL

Participants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart

Vaccination of placebo recipients with SCB-2019

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females ≥12 years of age, inclusive\*.
• 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.
• 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
• 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.
• 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.
• 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.
• Applicable for HIV-positive individuals only if:
• They are medically stable at screening, as determined by the investigator, and free of opportunistic infections in the 1 year prior to first study vaccination, and They have an HIV-1 viral load \<1000 copies/mL within 45 days of randomization in the study, and They are receiving highly active antiretroviral therapy (HAART) for at least 3 months before screening. Changes in antiretroviral dosage within 3 months of entering the study are allowed, as are exchanges in pharmacological formulations.

You may not qualify if:

• 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.
• Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the investigator.
• Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
• 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.
• Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.
• 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).
• 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).
• 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.
• Individuals who have received previous vaccination with any coronavirus vaccine.
• 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.
• Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period.
• Individuals with any condition that, in the opinion of the investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives.
• Individuals with fever \>37.8°C (irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization.

Sponsors & Collaborators

• Clover Biopharmaceuticals AUS Pty: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• International Vaccine Institute: collaborator

Study Sites (31)

Anima

Alken, 3570, Belgium

Location

Hôspital Erasme

Brussels, 1070, Belgium

Location

Private Practice RESPISOM Namur

Namur, 5101, Belgium

Location

Instituto D'OR de Pesquisa e Ensino

Rio de Janeiro, Rio Do Janeiro, 22281-100, Brazil

Location

Instituto Atena de Pesquisa Clinica

Natal, Rio Grande do Norte, 59020-500, Brazil

Location

CPCLIN - Centro de Pesquisas Clínicas de Natal

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital da Universidade Federal de Santa Maria CEP/UFSM

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

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

Acacías, Colombia

Location

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

Aguazul, Colombia

Location

Clínica de la Costa Ltda

Barranquilla, 080020, Colombia

Location

Fundación Hospital Universitario del Norte

Barranquilla, Colombia

Location

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Bogotá D.C.

Bogotá, Colombia

Location

Policlinico Social del Norte

Bogotá, Colombia

Location

Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.

Cali, Colombia

Location

IPS Médicos Internistas de Caldas SAS

Manizales, Colombia

Location

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

Yopal, 850001, Colombia

Location

De La Salle Medical and Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

Asian Hospital and Medical Center

City of Muntinlupa, 1781, Philippines

Location

St. Luke's Medical Center

City of Taguig, 1634, Philippines

Location

Las Pinas Doctors Hospital

Las Piñas, 1742, Philippines

Location

Tropical Disease Foundation

Makati, 1230, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

University of the Philippines Manila - Philippine General Hospital

Pasay, 1301, Philippines

Location

UERM Memorial Medical Center

Quezon City, 1100, Philippines

Location

University of the East Ramon Magsaysay Memorial Medical Center

Quezon City, 1100, Philippines

Location

FEU-NRMF Medical Center

Quezon City, 1118, Philippines

Location

Wits Clinical Research

Johannesburg, Gauteng, 2013, South Africa

Location

DJW Research

Krugersdorp, Gauteng, 1739, South Africa

Location

Soweto Clinical Trials Centre

Soweto, Gauteng, 1818, South Africa

Location

Dr JM Engelbrecht Trial Site

Somerset West, Western Cape, 7130, South Africa

Location

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MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride; SCB-2019 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Igor Smolenov, MD, PhD

  Clover Biopharmaceuticals AUS Pty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will receive 2 doses of their assigned treatment on Days 1 and 22. Booster dose will be given at least 4 months after the second dose (Day 1A for booster dose). The treatment will be administered IM in the deltoid region of the upper non-dominant arm

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 17, 2020
• Study Start: March 24, 2021
• Primary Completion: September 15, 2022
• Study Completion: April 23, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

ZA (4); BE (3); BR (5); CO (9); PH (10)