Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults

NCT05188677
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,831
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Lead sponsor
Clover Biopharmaceuticals AUS Pty
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Start date
2022-06-13
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Number of sites
2
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Summary
The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who: * Received primary series with one of the selected authorized or investigational COVID-19 vaccines at least 3 months prior to enrollment. * Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.
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Short title
Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
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Official title
A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, Who Previously Received Primary Series of a COVID-19 Vaccine
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-06-06
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First posted
2022-01-12
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Registry last updated
2023-08-24
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Primary completion date
2023-06-06
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Start date
2022-06-13
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Actual participants
1,831
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Participants
1,831
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
2
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Clover Biopharmaceuticals AUS Pty
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05188677
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ClinicalTrials.gov ID
NCT05188677
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15

    Timeframe: Day 15

  2. GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15

    Timeframe: Day 15

  3. GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15

    Timeframe: Day 15

  4. Local and systemic solicited AEs reported within 7 days after study vaccination

    Timeframe: Up to 7 days after each vaccination

  5. Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29

    Timeframe: Up to Day 29

  6. SAEs, AEs leading to early termination from the study, MAAEs, and AESIs

    Timeframe: Through study completion, an average of 6 Months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Male and female participants at least 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 primary vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥3 months prior to enrollment.

  • Individuals with fever >37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization;
  • Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR);
  • Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), or plan to receive COVID-19 vaccine 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 vaccines;
  • Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
Sources for eligibility
clinicaltrials.gov

  • Las Piñas Doctors HospitalLas Piñas, Philippines
  • Manila Doctors HospitalManila, Philippines
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)