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

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.

Timeline

Start

2021-03-24

Primary completion

2022-09-15

Completion

2023-04-23

Outcome

Met primary endpoint

paper an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8) PMID 35065705 ↗

release “Clover's adjuvanted protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) achieved the primary efficacy endpoint and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial.” cloverbiopharma.com ↗

Publications

• Background Liu H, Su D, Zhang J, Ge S, Li Y, Wang F, Gravel M, Roulston A, Song Q, Xu W, Liang JG, Shore G, Wang X, Liang P. Improvement of Pharmacokinetic Profile of TRAIL via Trimer-Tag Enhances its Antitumor Activity in vivo. Sci Rep. 2017 Aug 21;7(1):8953. doi: 10.1038/s41598-017-09518-1.
• Background Ruggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, de Souza Brito G, Heininger U, Imoukhuede B, Khamesipour A, Erlewyn-Lajeunesse M, Martin S, Makela M, Nell P, Pool V, Simpson N; Brighton Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5675-84. doi: 10.1016/j.vaccine.2007.02.064. Epub 2007 Mar 12. No abstract available.
• Background Rhodes SJ, Knight GM, Kirschner DE, White RG, Evans TG. Dose finding for new vaccines: The role for immunostimulation/immunodynamic modelling. J Theor Biol. 2019 Mar 21;465:51-55. doi: 10.1016/j.jtbi.2019.01.017. Epub 2019 Jan 10.
• Background Food and Drug Administration letter. Device: BinaxNOW COVID-19 Ag Card. 26 August 2020. https://www.fda.gov/media/141567/download. Accessed on 15 September 2020.
• Background Food and Drug Administration Guidance Document: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Available at https://www.fda.gov/media/73679/download. Accessed on 15 September 2020.
• Background Safety Platform for Emergency vACcines (SPEAC). D2.3 Priority List of Adverse Events of Special Interest: COVID-19. V1.1 Date 05 March 2020. https://media.tghn.org/articles/COVID-19_AESIs_SPEAC_V1.1_5Mar2020.pdf. Accessed on 15 September 2020.
• Background Chan ISF, Bohidar NR (1998) Exact power and sample size for vaccine efficacy studies, Communications in Statistics - Theory and Methods 1998;27(6):1305-22.
• Background Maurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. Stat Biopharm Res 2013;5(4):311-20.
• Aziz AB, Sugimoto JD, Hong SL, You YA, Bravo L, Roa C Jr, Borja-Tabora C, Montellano MEB, Carlos J, de Los Reyes MRA, Alberto ER, Salvani-Bautista M, Kim HY, Njau I, Clemens R, Marks F, Tadesse BT. Indirect effectiveness of a novel SARS-COV-2 vaccine (SCB-2019) in unvaccinated household contacts in the Philippines: A cluster randomised analysis. J Infect. 2024 Oct;89(4):106260. doi: 10.1016/j.jinf.2024.106260. Epub 2024 Aug 30.
• Lopez P, Bravo L, Buntinx E, Borja-Tabora C, Velasquez H, Rodriquez EJ, Rodriguez CA, Carlos J, Montellano MEB, Alberto ER, Salvani-Bautista M, Huang Y, Hu B, Li P, Han HH, Baccarini C, Smolenov I. Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12-17 year-old adolescents. Hum Vaccin Immunother. 2023 Dec 31;19(1):2206359. doi: 10.1080/21645515.2023.2206359. Epub 2023 May 25.
• Hosain R, Aquino P, Baccarini C, Smolenov I, Li P, Qin H, Verhoeven C, Hu B, Huang Y, Rubio P; SPECTRA Study Group. Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study. Vaccine. 2023 Mar 24;41(13):2253-2260. doi: 10.1016/j.vaccine.2023.02.018. Epub 2023 Feb 10.
• Buntinx E, Brochado L, Borja-Tabora C, Yu CY, Alberto ER, Montellano MEB, Carlos JC, Toloza LB, Hites M, Siber G, Clemens R, Ambrosino D, Qin H, Chen HL, Han HH, Hu B, Li P, Baccarini C, Smolenov I. Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naive and exposed individuals in a phase 2/3, double-blind, randomized study. Vaccine. 2023 Mar 10;41(11):1875-1884. doi: 10.1016/j.vaccine.2023.02.017. Epub 2023 Feb 9.
• Tadesse BT, Bravo L, Marks F, Aziz AB, You YA, Sugimoto J, Li P, Garcia J, Rockhold F, Clemens R; Household Contact Study Group. Impact of Vaccination With the SCB-2019 Coronavirus Disease 2019 Vaccine on Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Household Contact Study in the Philippines. Clin Infect Dis. 2023 Apr 3;76(7):1180-1187. doi: 10.1093/cid/ciac914.
• Bravo L, Smolenov I, Han HH, Li P, Hosain R, Rockhold F, Clemens SAC, Roa C Jr, Borja-Tabora C, Quinsaat A, Lopez P, Lopez-Medina E, Brochado L, Hernandez EA, Reynales H, Medina T, Velasquez H, Toloza LB, Rodriguez EJ, de Salazar DIM, Rodriguez CA, Sprinz E, Cerbino-Neto J, Luz KG, Schwarzbold AV, Paiva MS, Carlos J, Montellano MEB, de Los Reyes MRA, Yu CY, Alberto ER, Panaligan MM, Salvani-Bautista M, Buntinx E, Hites M, Martinot JB, Bhorat QE, Badat A, Baccarini C, Hu B, Jurgens J, Engelbrecht J, Ambrosino D, Richmond P, Siber G, Liang J, Clemens R. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2022 Jan 29;399(10323):461-472. doi: 10.1016/S0140-6736(22)00055-1. Epub 2022 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SCB-2019	Vaccine	30 ug	Intramuscular

Indications