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OpenTrials
Completed

NCT Number: NCT05188677

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

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.

Completed

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Las Piñas Doctors Hospital, Las Piñas, National Capital Region, Philippines

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Candidate vaccine, SCB-2019

Biological

a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Comirnaty Vaccine

Biological

intramuscular injection

Vaxzevria Vaccine

Biological

intramuscular injection

CoronaVac vaccine

Biological

intramuscular injection

Primary outcomes

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

    Time frame: Day 15

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

    Time frame: Day 15

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

    Time frame: Day 15

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

    Time frame: Up to 7 days after each vaccination

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

    Time frame: Up to Day 29

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

    Time frame: Through study completion, an average of 6 Months

Sponsors and collaborators

Lead sponsor

Clover Biopharmaceuticals AUS Pty

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2022
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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