COVID-19Phase 2/3SCB-2019NCT04672395

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

A Phase 2/3 study testing CpG 1018/Alum-adjuvanted SCB-2019 vaccine and SCB-2019 vaccine in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 31 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: CpG 1018/Alum-adjuvanted SCB-2019 vaccine and SCB-2019 vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31,454 participants
Where: 31 sitesin 5 countries
Study dates: 24 Mar 2021to 23 Apr 2023
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Male or females ≥12 years of age, inclusive*.
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.
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
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.

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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.
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.
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.
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.

Who cannot join

Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR* or Rapid COVID-19 Antigen test) at screening or within 14 days prior to enrollment.
Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the investigator.
Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
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.
Individuals who are pregnant, or breastfeeding, or planning to become pregnant 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 vaccine (SCB-2019, CpG1018 Adjuvant and Aluminum hydroxide components).

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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).
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.
Individuals who have received previous vaccination with any coronavirus vaccine.
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.
Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
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.
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.
Individuals with fever >37.8°C (irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization.

Trial locations and contacts

31 sites in 5 countries.

Country

City, postcode or hospital

31 sites in 5 countries

Philippines10 sites

Asian Hospital and Medical Center
City of Muntinlupa, 1781
St. Luke's Medical Center
City of Taguig, 1634
De La Salle Medical and Health Sciences Institute
Dasmariñas, Cavite, 4114
Las Pinas Doctors Hospital
Las Piñas, 1742
Tropical Disease Foundation
Makati, 1230
Manila Doctors Hospital
Manila, 1000
University of the Philippines Manila - Philippine General Hospital
Pasay, 1301
UERM Memorial Medical Center
Quezon City, 1100
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, 1100
FEU-NRMF Medical Center
Quezon City, 1118

Other trials in Philippines

Colombia9 sites

Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Acacias
Acacías
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede Aguazul
Aguazul
Clínica de la Costa Ltda
Barranquilla, 080020
Fundación Hospital Universitario del Norte
Barranquilla
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Bogotá D.C.
Bogotá
Policlinico Social del Norte
Bogotá
Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.
Cali
IPS Médicos Internistas de Caldas SAS
Manizales
Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Yopal
Yopal, 850001

Other trials in Colombia

Brazil5 sites

Instituto Atena de Pesquisa Clinica
Natal, Rio Grande do Norte, 59020-500
CPCLIN - Centro de Pesquisas Clínicas de Natal
Natal, Rio Grande do Norte, 59025-050
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Instituto D'OR de Pesquisa e Ensino
Rio de Janeiro, Rio Do Janeiro, 22281-100
Hospital da Universidade Federal de Santa Maria CEP/UFSM
Santa Maria, Rio Grande do Sul, 97105-900

Other trials in Brazil

South Africa4 sites

Wits Clinical Research
Johannesburg, Gauteng, 2013
DJW Research
Krugersdorp, Gauteng, 1739
Dr JM Engelbrecht Trial Site
Somerset West, Western Cape, 7130
Soweto Clinical Trials Centre
Soweto, Gauteng, 1818

Other trials in South Africa

Belgium3 sites

Anima
Alken, 3570
Hôspital Erasme
Brussels, 1070
Private Practice RESPISOM Namur
Namur, 5101

Other trials in Belgium

About this study

Official title: A Double-blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2- Mediated COVID-19 in Participants Aged 12 Years and Older

Read the detailed description

This study will assess the efficacy against COVID-19, immunogenicity, reactogenicity, and safety of CpG 1018/Alum-adjuvated SCB-2019 vaccine. The COVID-19 pandemic has resulted in high morbidity and mortality, caused major disruption to healthcare systems, and has had significant socioeconomic impacts. Currently, only limited treatment options are available against COVID-19 and accelerated vaccine development is urgently needed. Several COVID-19 vaccines were recently authorized in some countries, but the global supply is insufficient for pandemic control. Additional safe and effective vaccines for COVID-19 prevention would have significant public health impact.

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: COVID-19
Being tested: CpG 1018/Alum-adjuvanted SCB-2019 vaccine, Placebo; 0.9% saline, SCB-2019 vaccine, SCB-2019 vaccine for Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CpG 1018/Alum-adjuvanted SCB-2019 vaccineBiological
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% salineBiological
Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22
SCB-2019 vaccineBiological
Participants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant
SCB-2019 vaccine for PlaceboBiological
Participants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart

Study groups in NCT04672395
Study group	Role	What they receive
Group 1	Experimental	CpG 1018/Alum-adjuvanted SCB-2019 vaccine Receives: Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine
Group 2	Placebo comparator	Placebo Comparator: 0.9% Saline Receives: Biological: Placebo; 0.9% saline
Booster dose of SCB-2019	Experimental	Adult SCB-2019 recipients will receive 1 dose of SCB-2019 at least 4 months after the second dose Receives: Biological: SCB-2019 vaccine
Vaccination of placebo recipients with SCB-2019	Placebo comparator	Placebo participants will be offered two doses of SCB-2019 vaccine Receives: Biological: SCB-2019 vaccine for Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 8 (7 days after first dose) and up to Day 29 (7 days after second dose)
Number of Participants with Unsolicited AEs
Measured: Up to Day 43 (21 days after each dose)
Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)
Measured: Up to Day 389 (1 year after second dose)
Non-inferiority of the neutralizing titers after third dose compared to the neutralizing titers after second dose
Measured: 14 days after third dose
Non-inferiority of the neutralising titers in adolescents versus young adults.
Measured: 14 days after second dose

Secondary outcomes (30)

Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo
Measured: Day 36 up to Day 389 (1 year after second dose)
Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 of Any Severity, Associated with Hospitalization, Starting 14 Days after Second Dose of SCB-2019 or Placebo
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of evidence of prior SARS-CoV-2 Infection
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of risk of severe COVID-19
Measured: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of SCB-2019 or Placebo
Measured: Day 15 up to Day 22
Number of Participants with a First Occurrence of COVID-19 of Any Severity caused by SARS-CoV-2 variants of concern starting 14 days after Second Dose
Measured: Day 36 up to Day 389 (1 year after second dose)
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of SCB-2019 binding antibody
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for SCB-2019 binding antibody
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of Trimer-Tag binding antibody
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of Trimer-Tag binding antibody
Measured: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to 7 days after booster dose
Number of Participants with Unsolicited AEs
Measured: Up to 21 days after booster dose
Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)
Measured: Up to 6 months after booster dose
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific nAb
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Titer (GMT) of SCB-2019 binding antibody
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Number of Participants with Seroconversion for SCB-2019 binding antibody
Measured: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202123 Apr 2023

First posted17 Dec 2020
Study start24 Mar 2021
Primary completion15 Sep 2022
Study completion23 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Each subject will receive 2 doses of their assigned treatment on Days 1 and 22. Booster dose will be given at least 4 months after the second dose (Day 1A for booster dose). The treatment will be administered IM in the deltoid region of the upper non-dominant arm
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31,454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04672395
Sponsor's protocol ID: CLO-SCB-2019-003
Acronym: SCB-2019
Status last verified: Jun 2023
First submitted: 16 Dec 2020
Last updated: 29 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 28827692
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.
PubMed 17448577
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.
PubMed 30639297
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.
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.
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.
PubMed 39218309
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.
PubMed 37226504
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.
PubMed 36868877
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.
PubMed 36781334
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.
PubMed 36433685
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.
PubMed 35065705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2- Mediated COVID-19 in Participants Aged 12 Years and Older
ClinicalTrials.gov ID: NCT04672395
Acronym / sponsor ID: SCB-2019 / CLO-SCB-2019-003
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31,454 participants (actual)
Lead sponsor: Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
Collaborators: Coalition for Epidemic Preparedness Innovations, International Vaccine Institute
Study start: 24 Mar 2021 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 23 Apr 2023 (actual)
First posted: 17 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Placebo recipients will be offered two doses of SCB-2019 vaccine at defined points as part of the study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Each subject will receive 2 doses of their assigned treatment on Days 1 and 22. Booster dose will be given at least 4 months after the second dose (Day 1A for booster dose). The treatment will be administered IM in the deltoid region of the upper non-dominant arm

Arm	Type	Receives
Group 1	Experimental	Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccineCpG 1018/Alum-adjuvanted SCB-2019 vaccine
Group 2	Placebo comparator	Biological: Placebo; 0.9% salinePlacebo Comparator: 0.9% Saline
Booster dose of SCB-2019	Experimental	Biological: SCB-2019 vaccineAdult SCB-2019 recipients will receive 1 dose of SCB-2019 at least 4 months after the second dose
Vaccination of placebo recipients with SCB-2019	Placebo comparator	Biological: SCB-2019 vaccine for PlaceboPlacebo participants will be offered two doses of SCB-2019 vaccine

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Male or females ≥12 years of age, inclusive*.
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.
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
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:

Key exclusion criteria (14 listed)

Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR* or Rapid COVID-19 Antigen test) at screening or within 14 days prior to enrollment.
Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the investigator.
Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
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.
Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CpG 1018/Alum-adjuvanted SCB-2019 vaccineGroup 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	Biological	Group 1
Placebo; 0.9% salineGroup 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22	Biological	Group 2
SCB-2019 vaccineParticipants will receive 1 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant	Biological	Booster dose of SCB-2019
SCB-2019 vaccine for PlaceboParticipants will receive 2 IM injection of 30 microgram (ug) SCB-2019 with CpG 1018/alum adjuvant, 21 days apart	Biological	Vaccination of placebo recipients with SCB-2019

Primary outcome

Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 8 (7 days after first dose) and up to Day 29 (7 days after second dose)
Number of Participants with Unsolicited AEs
Time frame: Up to Day 43 (21 days after each dose)
Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)
Time frame: Up to Day 389 (1 year after second dose)
Non-inferiority of the neutralizing titers after third dose compared to the neutralizing titers after second dose
Time frame: 14 days after third dose
Non-inferiority of the neutralising titers in adolescents versus young adults.
Time frame: 14 days after second dose

30 secondary outcomes

Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo
Time frame: Day 36 up to Day 389 (1 year after second dose)
Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 of Any Severity, Associated with Hospitalization, Starting 14 Days after Second Dose of SCB-2019 or Placebo
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of evidence of prior SARS-CoV-2 Infection
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of risk of severe COVID-19
Time frame: Day 36 up to Day 389 (1 year after second dose)
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of SCB-2019 or Placebo
Time frame: Day 15 up to Day 22
Number of Participants with a First Occurrence of COVID-19 of Any Severity caused by SARS-CoV-2 variants of concern starting 14 days after Second Dose
Time frame: Day 36 up to Day 389 (1 year after second dose)
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of SCB-2019 binding antibody
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Seroconversion for SCB-2019 binding antibody
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Titer (GMT) of Trimer-Tag binding antibody
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Geometric Mean Fold Rise (GMFR) of Trimer-Tag binding antibody
Time frame: Day 1, Day 22, Day 35, Day 205, and Day 389
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to 7 days after booster dose
Number of Participants with Unsolicited AEs
Time frame: Up to 21 days after booster dose
Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)
Time frame: Up to 6 months after booster dose
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific nAb
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Titer (GMT) of SCB-2019 binding antibody
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)
Number of Participants with Seroconversion for SCB-2019 binding antibody
Time frame: Day 1A, Day 15A (15 days after booster), and Day 389A (6 months after booster)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Background: PubMed 28827692Liu 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: PubMed 17448577Ruggeberg 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: PubMed 30639297Rhodes 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.
BackgroundFood 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.
BackgroundFood 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.
BackgroundSafety 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.
BackgroundChan ISF, Bohidar NR (1998) Exact power and sample size for vaccine efficacy studies, Communications in Statistics - Theory and Methods 1998;27(6):1305-22.
BackgroundMaurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. Stat Biopharm Res 2013;5(4):311-20.
Derived from this study: PubMed 39218309Aziz 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.
Derived from this study: PubMed 37226504Lopez 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.
Derived from this study: PubMed 36868877Hosain 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.
Derived from this study: PubMed 36781334Buntinx 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Igor Smolenov, MD, PhD study chair

Clover Biopharmaceuticals AUS Pty

31 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CpG 1018/Alum-adjuvanted SCB-2019 vaccine and SCB-2019 vaccine in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Philippines, Colombia, Brazil, South Africa, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019 (time frame: Day 36 up to Day 389 (1 year after second dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04672395, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.