A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19
NCT ID: NCT04672395
Last Updated: 2023-06-29
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
31454 participants
INTERVENTIONAL
2021-03-24
2023-04-23
Brief Summary
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Detailed Description
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Placebo recipients will be offered two doses of SCB-2019 vaccine at defined points as part of the study.
Adults participants who received SCB-2019 vaccine, will be given a third dose of the SCB-2019 vaccine at least 4 months after the second dose to assess the safety and efficacy of a booster (third) dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1
CpG 1018/Alum-adjuvanted SCB-2019 vaccine
CpG 1018/Alum-adjuvanted SCB-2019 vaccine
Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG1018/Alum adjuvant on Day 1 and on Day 22
Group 2
Placebo Comparator: 0.9% Saline
Placebo; 0.9% saline
Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22
Booster dose of SCB-2019
Adult SCB-2019 recipients will receive 1 dose of SCB-2019 at least 4 months after the second dose
SCB-2019 vaccine
Participants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant
Vaccination of placebo recipients with SCB-2019
Placebo participants will be offered two doses of SCB-2019 vaccine
SCB-2019 vaccine for Placebo
Participants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart
Interventions
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CpG 1018/Alum-adjuvanted SCB-2019 vaccine
Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG1018/Alum adjuvant on Day 1 and on Day 22
Placebo; 0.9% saline
Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22
SCB-2019 vaccine
Participants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant
SCB-2019 vaccine for Placebo
Participants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart
Eligibility Criteria
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Inclusion Criteria
2. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, the electronic completion of the COVID-19 ePRO and other study procedures.
3. Healthy adult or adolescent subjects or adult or adolescent subjects with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
\*Note: The first 200 individuals enrolled in the Phase 2 part of the study should be healthy subjects 18 to 64 years or age without comorbidities associated with a high risk of severe COVID-19
4. Female subjects who are WOCBP are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
* WOCBP must have a negative urine pregnancy test prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the investigator's discretion.
* They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the second vaccination.
5. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period.
6. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening. For adolescent subjects: informed assent signed by adolescents and informed consent signed by the parent(s) or legally acceptable representative(s) as per local requirements.
7. Applicable for HIV-positive individuals only if:
They are medically stable at screening, as determined by the investigator, and free of opportunistic infections in the 1 year prior to first study vaccination, and They have an HIV-1 viral load \<1000 copies/mL within 45 days of randomization in the study, and They are receiving highly active antiretroviral therapy (HAART) for at least 3 months before screening. Changes in antiretroviral dosage within 3 months of entering the study are allowed, as are exchanges in pharmacological formulations.
Exclusion Criteria
2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the investigator.
3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period.
5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.
6. 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 vaccine (SCB-2019, CpG1018 Adjuvant and Aluminum hydroxide components).
7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.
9. Individuals who have received previous vaccination with any coronavirus vaccine.
10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination.
11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period.
13. Individuals with any condition that, in the opinion of the investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives.
14. Individuals with fever \>37.8°C (irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization.
12 Years
ALL
Yes
Sponsors
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Coalition for Epidemic Preparedness Innovations
OTHER
International Vaccine Institute
OTHER
Clover Biopharmaceuticals AUS Pty
INDUSTRY
Responsible Party
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Principal Investigators
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Igor Smolenov, MD, PhD
Role: STUDY_CHAIR
Clover Biopharmaceuticals AUS Pty
Locations
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Anima
Alken, , Belgium
Hôspital Erasme
Brussels, , Belgium
Private Practice RESPISOM Namur
Namur, , Belgium
Instituto D'OR de Pesquisa e Ensino
Rio de Janeiro, Rio Do Janeiro, Brazil
Instituto Atena de Pesquisa Clinica
Natal, Rio Grande do Norte, Brazil
CPCLIN - Centro de Pesquisas Clínicas de Natal
Natal, Rio Grande do Norte, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital da Universidade Federal de Santa Maria CEP/UFSM
Santa Maria, Rio Grande do Sul, Brazil
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Acacias
Acacías, , Colombia
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede Aguazul
Aguazul, , Colombia
Clínica de la Costa Ltda
Barranquilla, , Colombia
Fundación Hospital Universitario del Norte
Barranquilla, , Colombia
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Bogotá D.C.
Bogotá, , Colombia
Policlinico Social del Norte
Bogotá, , Colombia
Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.
Cali, , Colombia
IPS Médicos Internistas de Caldas SAS
Manizales, , Colombia
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Yopal
Yopal, , Colombia
De La Salle Medical and Health Sciences Institute
Dasmariñas, Cavite, Philippines
Asian Hospital and Medical Center
City of Muntinlupa, , Philippines
St. Luke's Medical Center
City of Taguig, , Philippines
Las Pinas Doctors Hospital
Las Piñas, , Philippines
Tropical Disease Foundation
Makati, , Philippines
Manila Doctors Hospital
Manila, , Philippines
University of the Philippines Manila - Philippine General Hospital
Pasay, , Philippines
UERM Memorial Medical Center
Quezon City, , Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, , Philippines
FEU-NRMF Medical Center
Quezon City, , Philippines
Wits Clinical Research
Johannesburg, Gauteng, South Africa
DJW Research
Krugersdorp, Gauteng, South Africa
Soweto Clinical Trials Centre
Soweto, Gauteng, South Africa
Dr JM Engelbrecht Trial Site
Somerset West, Western Cape, South Africa
Countries
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References
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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.
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.
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.
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.
Amai M, Nojima M, Yuki Y, Kiyono H, Nagamura F. A review of criteria strictness in "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". Vaccine. 2023 Aug 31;41(38):5622-5629. doi: 10.1016/j.vaccine.2023.07.072. Epub 2023 Aug 1.
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.
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.
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.
Other Identifiers
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CLO-SCB-2019-003
Identifier Type: -
Identifier Source: org_study_id
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