Trials / Completed
CompletedNCT04405908
SCB-2019 as COVID-19 Vaccine
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 166 (actual)
- Sponsor
- Clover Biopharmaceuticals AUS Pty · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with and without adjuvant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCB-2019 | SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22). |
| BIOLOGICAL | SCB-2019 with AS03 adjuvant | SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant. |
| BIOLOGICAL | SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant | SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant. |
| BIOLOGICAL | SCB-2019 with Alum adjuvant | SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant. |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2021-10-20
- Completion
- 2021-12-08
- First posted
- 2020-05-28
- Last updated
- 2022-02-18
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04405908. Inclusion in this directory is not an endorsement.