COVID-19Phase 1NCT04405908

SCB-2019 as COVID-19 Vaccine

A Phase 1 study testing SCB-2019, SCB-2019 with AS03 adjuvant and SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 1 site in Australia.

Completed

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

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: SCB-2019, SCB-2019 with AS03 adjuvant and SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteAustralia
Study dates: 19 Jun 2020to 8 Dec 2021
Phase: Phase 1
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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult male or females, ≥18 years of age at Screening:
For the adult group: 18 to 54 years, inclusive, and
For the elderly group: 55 to 75 years, inclusive.
Individuals who are willing and able to give an informed consent, prior to Screening.
Individuals who are able to comply with study requirements.
Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:

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Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to each vaccination. They must be using a highly effective licensed method of birth control for 30 days prior to the first dose of the study vaccine/placebo and must agree to continue such precautions during the study until 60 days after the second dose of the study vaccine/placebo.
Women not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (no menses for 12 months and follicle-stimulating hormone [FSH] in the postmenopausal range).
Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 90 days after the second dose of the study vaccine/placebo and also refrain from donating sperm during this period.
General good health based on medical history, physical examination, cardiac health evaluation, and clinical laboratory evaluations. Participants in the elderly population who have medically stable, well-controlled co-morbidities may be enrolled at the discretion of the Investigator.
All clinical laboratory values should be within normal reference ranges unless confirmed by Investigator or delegate as not clinically significant. One repeat evaluation of electrocardiogram (ECG), and clinical laboratory tests will be permitted, at the discretion of the Investigator.
Individuals agree to avoid strenuous exercise from Screening to Day 50.
For the SARS-CoV-2 seropositive treatment group only (Treatment Groups 16 to 18):
Serological or ELISA confirmation of SARS-CoV-2;
No history of severe SARS-CoV-2 symptoms;
No SARS-CoV-2 symptoms at the time of the screening .

Who cannot join

Individuals with any positive test for SARS-CoV-2 infection, including but not limited to RT-PCR, at Screening (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
Individuals with known or suspected impairment of the immune system, such as:

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Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to Day 1. Use of inhaled, intranasal, or topical corticosteroids is allowed.Note: Systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the study vaccine/placebo.
Receipt of cancer chemotherapy within 5 years prior to Day 1.
Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.
Known HIV or acquired immune deficiency syndrome (AIDS).
Subjects with active or prior documented autoimmune disorder (such as potential immune-mediated diseases [pIMDs]).
Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study.
Positive serology test results for hepatitis C virus antibody, HIV antibody, and/or hepatitis B virus surface antigen at Screening.
Individuals who are pregnant or breastfeeding.
Individuals who are allergic to any of the study vaccine/placebo components as outlined in the current SCB 2019 IB.
Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the date of first administration of the study vaccine/placebo (Day 1).
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 with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
Individuals who have a previous confirmed or suspected illness caused by coronaviruses, SARS-CoV-1, SARS-CoV-2, and Middle East Respiratory Syndrome (MERS)-CoV (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
Individuals who have received any prior vaccine against a coronavirus, including but not limited to SARS-CoV, SARS-CoV-2, MERS-CoV.
Individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days (before or after) the study vaccine/placebos, with the exception of the seasonal influenza vaccine.
Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS CoV 2 infection and/or its complications.
Individuals with known bleeding diathesis.
Individuals with a body mass index <18.5 kg/m2 or >35.0 kg/m2.
Individuals with a history of drug or alcohol abuse within the past 2 years.
Individuals with a history of anaphylaxis or angioedema including but not limited to history of anaphylaxis after any vaccine.
Individuals with any condition that, in the opinion of the Investigator, would interfere with the primary study objectives or pose additional subject risk.
Individuals who are research staff involved with the clinical study or family/household members of research staff.
Individuals must not have donated blood for 2 months prior to Day 1 and must agree to not donate blood for 6 months post Day 1 (receipt of first dose of study vaccine).

Trial locations and contacts

1 site in 1 country.

Australia1 site

Linear Clinical Research Ltd
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: 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.

Conditions: COVID-19
Being tested: SCB-2019, SCB-2019 with AS03 adjuvant, SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant, SCB-2019 with Alum adjuvant
Medical subject headings: COVID-19

What participants receive

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

SCB-2019Biological
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
SCB-2019 with AS03 adjuvantBiological
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantBiological
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.
SCB-2019 with Alum adjuvantBiological
SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.

Study groups in NCT04405908
Study group	Role	What they receive
Adult Group 1	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg. Receives: Biological: SCB-2019
Adult Group 2	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Adult Group 3	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Adult Group 4	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg . Receives: Biological: SCB-2019
Adult Group 5	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Adult Group 6	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Adult Group 7	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg . Receives: Biological: SCB-2019
Adult Group 8	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Adult Group 9	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Elderly Group 10	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Elderly Group 11	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Elderly Group 12	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Elderly Group 13	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Elderly Group 14	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Elderly Group 15	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SARS-CoV-2 Seropositive Group 16	Placebo comparator	SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg. Receives: Biological: SCB-2019
SARS-CoV-2 Seropositive Group 17	Placebo comparator	SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
SARS-CoV-2 Seropositive Group 18	Placebo comparator	SARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Adjuvant Dose Modification: Adult Group 19	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Adjuvant Dose Modification: Adult Group 20	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Adjuvant Dose Modification: Elderly Group 21	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Adjuvant Dose Modification: Elderly Group 22	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Alum Only Adjuvant Group 23	Placebo comparator	Subjects receive SCB-2019 9 µg with Alum adjuvant only. Receives: Biological: SCB-2019 with Alum adjuvant
Dose Expansion Phase: Adult Group 24	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Dose Expansion Phase: Adult Group 25	Placebo comparator	Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Dose Expansion Phase: Elderly Group 26	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant. Receives: Biological: SCB-2019 with AS03 adjuvant
Dose Expansion Phase: Elderly Group 27	Placebo comparator	Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant. Receives: Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant

What is being measured

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

Incidence of solicited adverse events (AEs) after vaccination
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Measured: 7 days after the first or second vaccination.
Incidence of unsolicited AEs after vaccination
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Measured: Day 1 to Day 50
Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Measured: Day 1 to Day 50
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Measured: Day 1 to Day 184
As assessed by serum anti-SCB-2019 IgG antibody titers
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Measured: Day 1 to Day 184

Secondary outcomes (4)

Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Measured: Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Measured: Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Measured: Day 1 to Day 184
Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Measured: Day 1 to Day 184

Timeline

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

19 Jun 20208 Dec 2021

First posted28 May 2020
Study start19 Jun 2020
Primary completion20 Oct 2021
Study completion8 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04405908
Sponsor's protocol ID: CLO-SCB-2019-001
Status last verified: Feb 2022
First submitted: 25 May 2020
Last updated: 18 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R. 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. Lancet. 2021 Feb 20;397(10275):682-694. doi: 10.1016/S0140-6736(21)00241-5. Epub 2021 Jan 29.
PubMed 33524311

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 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04405908
Acronym / sponsor ID: CLO-SCB-2019-001
Conditions: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
Study start: 19 Jun 2020 (actual)
Primary completion: 20 Oct 2021 (actual)
Study completion: 8 Dec 2021 (actual)
First posted: 28 May 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 27

Arm	Type	Receives
Adult Group 1	Placebo comparator	Biological: SCB-2019Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.
Adult Group 2	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
Adult Group 3	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
Adult Group 4	Placebo comparator	Biological: SCB-2019Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .
Adult Group 5	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adult Group 6	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
Adult Group 7	Placebo comparator	Biological: SCB-2019Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .
Adult Group 8	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
Adult Group 9	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 10	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
Elderly Group 11	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 12	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Elderly Group 13	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 14	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
Elderly Group 15	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SARS-CoV-2 Seropositive Group 16	Placebo comparator	Biological: SCB-2019SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.
SARS-CoV-2 Seropositive Group 17	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantSARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.
SARS-CoV-2 Seropositive Group 18	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantSARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Adult Group 19	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adjuvant Dose Modification: Adult Group 20	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Elderly Group 21	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adjuvant Dose Modification: Elderly Group 22	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Alum Only Adjuvant Group 23	Placebo comparator	Biological: SCB-2019 with Alum adjuvantSubjects receive SCB-2019 9 µg with Alum adjuvant only.
Dose Expansion Phase: Adult Group 24	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Dose Expansion Phase: Adult Group 25	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Dose Expansion Phase: Elderly Group 26	Placebo comparator	Biological: SCB-2019 with AS03 adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Dose Expansion Phase: Elderly Group 27	Placebo comparator	Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Healthy adult male or females, ≥18 years of age at Screening:
Individuals who are willing and able to give an informed consent, prior to Screening.
Individuals who are able to comply with study requirements.
Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
General good health based on medical history, physical examination, cardiac health evaluation, and clinical laboratory evaluations. Participants in the elderly population who have medically stable, well-controlled co-morbidities may be enrolled at the discretion of the Investigator.

Key exclusion criteria (29 listed)

Individuals with any positive test for SARS-CoV-2 infection, including but not limited to RT-PCR, at Screening (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.

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
SCB-2019SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).	Biological	Adult Group 1, Adult Group 4, Adult Group 7, SARS-CoV-2 Seropositive Group 16
SCB-2019 with AS03 adjuvantSCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.	Biological	Adjuvant Dose Modification: Adult Group 19, Adjuvant Dose Modification: Elderly Group 21, Adult Group 2, Adult Group 5, Adult Group 8, Dose Expansion Phase: Adult Group 24, Dose Expansion Phase: Elderly Group 26, Elderly Group 10, Elderly Group 12, Elderly Group 14, SARS-CoV-2 Seropositive Group 17
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvantSCB-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	Adjuvant Dose Modification: Adult Group 20, Adjuvant Dose Modification: Elderly Group 22, Adult Group 3, Adult Group 6, Adult Group 9, Dose Expansion Phase: Adult Group 25, Dose Expansion Phase: Elderly Group 27, Elderly Group 11, Elderly Group 13, Elderly Group 15, SARS-CoV-2 Seropositive Group 18
SCB-2019 with Alum adjuvantSCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.	Biological	Alum Only Adjuvant Group 23

Primary outcome

Incidence of solicited adverse events (AEs) after vaccination
Time frame: 7 days after the first or second vaccination.
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Incidence of unsolicited AEs after vaccination
Time frame: Day 1 to Day 50
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
Time frame: Day 1 to Day 50
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Time frame: Day 1 to Day 184
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
As assessed by serum anti-SCB-2019 IgG antibody titers
Time frame: Day 1 to Day 184
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).

4 secondary outcomes

Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )
Time frame: Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )
Time frame: Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)
Time frame: Day 1 to Day 184
Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
Time frame: Day 1 to Day 184

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 18 Feb 2022.
Derived from this study: PubMed 33524311Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R. 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. Lancet. 2021 Feb 20;397(10275):682-694. doi: 10.1016/S0140-6736(21)00241-5. Epub 2021 Jan 29.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 29 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of solicited adverse events (AEs) after vaccination (time frame: 7 days after the first or second vaccination.). The study lists 5 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 NCT04405908, which also lists 1 linked publication.

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 18 Feb 2022.