Drugs / SCB-2019
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04932824 | Jan → Nov 2021 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05087368 | Dec 2021 → Apr 2022 | COVID-19 | D'Or Institute for Research and Education | Unknown | No outcome recorded |
| Phase 2 | NCT04954131 | Aug → Nov 2021 | COVID-19 | Zhejiang Clover Biopharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 2/32 trials · 2 met primary | ||||||
| Phase 2/3 | NCT05193279 | Oct → Dec 2022 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Withdrawn | Met primary Stop: Enrollment |
| Phase 2/3 | NCT04672395 | Mar 2021 → Sep 2022 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Completed | Met primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT05812586 | Mar → Jun 2023 | COVID-19 | D'Or Institute for Research and Education | Unknown | No outcome recorded |
| Phase 3 | NCT05188677 | Jun 2022 → Jun 2023 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Completed | No outcome recorded |
| Phase 3 | NCT05012787 | Nov 2021 → Mar 2022 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT05228314 Comparator | May → Sep 2022 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Completed | No outcome recorded |
| Phase 1 | NCT04405908 Comparator | Jun 2020 → Oct 2021 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Completed | No outcome recorded |
| Phase 3 | NCT06567457 Comparator | Oct 2023 → Sep 2024 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Withdrawn | No outcome recorded |
| Phase 3 | NCT05926440 Comparator | Aug 2023 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2022-11-30 | Clover Biopharmaceuticals AUS Pty | Results Clover's Vaccine Candidate Reduced Household Transmission of SARS-CoV-2 in Study Published in Clinical Infectious Diseases cloverbiopharma.com ↗ |
| 2022-10-09 | Clover Biopharmaceuticals AUS Pty | Results Clover Provides Update on 2022 Corporate Milestones cloverbiopharma.com ↗
New data demonstrating superiority as a heterologous booster compared to inactivated vaccine, robust neutralization of globally dominant Omicron BA.5 strain, and 84% reduction in transmission of SARS-CoV-2 infection to household contacts |
| 2022-09-20 | Clover Biopharmaceuticals AUS Pty | Results Clover's Universal COVID-19 Booster Vaccine Candidate Demonstrates Superior Neutralization of Omicron BA.5 Compared to Inactivated Vaccine cloverbiopharma.com ↗
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced positive data from its ongoing Phase 3 study evaluating Clover’s SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine candidate. |
| 2022-09-06 | Clover Biopharmaceuticals AUS Pty | Results Clover's COVID-19 Vaccine Candidate Demonstrates Superior Booster Responses Compared to Inactivated Vaccine cloverbiopharma.com ↗
Clover's COVID-19 Vaccine Candidate Demonstrates Superior Booster Responses Compared to Inactivated Vaccine |
| 2022-08-30 | Clover Biopharmaceuticals AUS Pty | Results Clover's COVID-19 Booster Vaccine Candidate Demonstrates Robust Neutralization of Dominant Omicron BA.5 cloverbiopharma.com ↗
BA.5 neutralizing antibody levels were approximately two to four-fold higher than BA.1 neutralizing antibody levels, demonstrating a potentially differentiated breadth of neutralization against the globally dominant BA.5 subvariant by SCB-2019 (CpG 1018/Alum) vaccination |
| 2022-08-25 | Clover Biopharmaceuticals AUS Pty | Results Clover Announces Positive Phase 2/3 Results in Adolescents for its COVID-19 Vaccine cloverbiopharma.com ↗
Clover Announces Positive Phase 2/3 Results in Adolescents for its COVID-19 Vaccine |
| 2022-06-27 | Clover Biopharmaceuticals AUS Pty | Results Clover's COVID-19 Vaccine Candidate Demonstrates Strong Cross-Neutralization Against Omicron as a Homologous Booster cloverbiopharma.com ↗
A homologous booster dose of SCB-2019 (CpG 1018/Alum) demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants. |
| 2022-04-20 | Clover Biopharmaceuticals AUS Pty | Results Clover's Efficacy Data in Previously-Infected Individuals is Published in Lancet Infectious Disease cloverbiopharma.com ↗
SCB-2019 (CpG 1018/Alum) provides significant incremental protection against COVID-19 in a previously-infected participant population |
| 2022-04-19 | Clover Biopharmaceuticals AUS Pty | Results Clover Presents Updated Durability and Booster Data for COVID-19 Vaccine Candidate at World Vaccine Congress Washington 2022 cloverbiopharma.com ↗
today announced additional positive data from two ongoing studies evaluating SCB-2019 (CpG 1018/Alum), which demonstrated durable protection through approximately six months following primary vaccination |
| 2022-03-17 | Clover Biopharmaceuticals AUS Pty | Results Clover's COVID-19 Vaccine Candidate Demonstrates Durable High Protection and Immune Responses Against Omicron as a Booster cloverbiopharma.com ↗
Together, these results demonstrated durable, high efficacy after primary vaccination and robust immune response against Omicron as a booster and provide strong evidence for utilization of SCB-2019 (CpG 1018/Alum) for primary vaccination and as a universal COVID-19 booster candidate. |
| 2021-09-22 | Clover Biopharmaceuticals AUS Pty | Results Clover's COVID-19 Vaccine Candidate Demonstrates 79% Efficacy Against Delta in Global Phase 2/3 SPECTRA Trial Dominated by Variants of Concern and Interest cloverbiopharma.com ↗
SCB-2019 (CpG 1018/Alum) demonstrated 79% overall efficacy against COVID-19 of any severity caused by the globally dominant Delta variant, which currently comprises over 90% of all cases worldwide. |
| 2021-09-10 | Clover Biopharmaceuticals AUS Pty | Regulatory Clover Biopharmaceuticals Receives Pharmaceutical Manufacturing Permit from Zhejiang Medical Products Administration to Produce COVID-19 Vaccine cloverbiopharma.com ↗
Clover Biopharmaceuticals Receives Pharmaceutical Manufacturing Permit from Zhejiang Medical Products Administration to Produce COVID-19 Vaccine |
| 2021-02-01 | Clover Biopharmaceuticals AUS Pty | Results Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet cloverbiopharma.com ↗
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial |
| 2020-12-04 | Clover Biopharmaceuticals AUS Pty | Results Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates cloverbiopharma.com ↗
Clover’s protein-based COVID-19 vaccine candidates adjuvanted with either GSK’s pandemic adjuvant system or Dynavax’s CpG 1018 plus alum induced strong neutralizing immune responses in 150 adult and elderly subjects from the Phase 1 clinical study. |
| 2020-09-25 | Clover Biopharmaceuticals AUS Pty | Results Clover Announces Positive Preclinical Data and Updates on Phase 1 Study for its Adjuvanted S-Trimer COVID-19 Vaccine Candidate cloverbiopharma.com ↗
The manuscript describing the results titled “S-Trimer, a COVID-19 subunit vaccine candidate, induces protective immunity in nonhuman primates” has been published in Nature Communications. |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SCB 2019 | “This study is to evaluate the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB 2019)...” NCT05012787 ↗ |
| Known as | S-Trimer | “Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial.” PMID 33524311 ↗ Jan 2021 |
| Modality | Vaccine | “a protein subunit vaccine candidate for COVID-19” PMID 33524311 ↗ Jan 2021 |
| Route | Intramuscular | “SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).” NCT04405908 ↗ |