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Trial registered on ANZCTR


Registration number
ACTRN12620000674932
Ethics application status
Approved
Date submitted
5/06/2020
Date registered
12/06/2020
Date last updated
24/07/2020
Date data sharing statement initially provided
12/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An interventional study to evaluate the safety and immune response of a vaccine against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19 infection) when given to healthy adult participants.
Scientific title
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Dosage-Escalation, Single Centre Study To Evaluate The Safety And Immunogenicity Of An Adjuvanted SARS-CoV-2 Sclamp Protein Subunit Vaccine (COVID-19 vaccine) In Healthy Adults Aged 18 To 55 Years Old
Secondary ID [1] 301329 0
UQ-1-SARS-CoV-2-Sclamp
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317529 0
Condition category
Condition code
Infection 315622 315622 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive two single intramuscular (IM) doses (of 5, 15 or 45 mcg) of the following study treatments at 28 days apart as follows:
IM administration (to the deltoid region of the subjects non dominant arm, administered by a registered nurse [RN]) of SARS-CoV-2 Sclamp adjuvanted vaccine, or matching placebo, administered on Days 1 and 29, of one of the following treatments:
Treatment A (Test 1): SARS-CoV-2 Sclamp vaccine 1 x 5 mcg in 0.5 mL suspension, administered as two separate doses at least 28 days apart
Treatment B (Test 2): SARS-CoV-2 Sclamp vaccine 1 x 15 mcg in 0.5 mL suspension, administered as two separate doses , at least 28 days apart
Treatment C (Test 3): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL suspension, administered as two separate doses at least 28 days apart
Treatment D (Test 4): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL suspension, administered as the first dose, followed by placebo as the second dose at least 28 days apart
Intervention code [1] 317626 0
Prevention
Comparator / control treatment
Placebo: 0.5 mL solution (sterile Saline for injection)
Control group
Placebo

Outcomes
Primary outcome [1] 323858 0
To assess the safety and tolerability of SARS-CoV-2 Sclamp vaccine compared to placebo by evaluating:
- the frequency, duration and intensity of solicited local adverse events (AEs), including pain, redness, induration
- the frequency, duration and intensity of solicited systemic AEs, including fever, nausea, chills, diarrhoea, headache, fatigue, myalgia
- the frequency, duration, intensity, and relatedness of unsolicited AEs through to Day 57.
Solicited AEs will be assessed by severity score, frequency, duration and intensity by FDA toxicity scoring.
Timepoint [1] 323858 0
Information on solicited AEs (local and systemic) will be collected for the 7 days following each vaccination (at Days 1 and 29)
Information on unsolicited AEs, SAEs and MAAEs will be collected from the time of consent through to study completion, Study completion is anticipated to be 12 months after the first dose of vaccine.
Information on any AEs leading to withdrawal will be collected from time of consent to the time of withdrawal/ study completion. Study completion is anticipated to be 12 months after the first dose of vaccine.
An interim analysis will be conducted after the first vaccination (Day 29), with the final analysis at the conclusion of the active study period (Day 57). Addenda to the study report will be produced for 6-month and 12-month follow-up data.
Primary outcome [2] 323859 0
To assess the total serum antibody immune responses elicited by SARS-CoV-2 Sclamp vaccine compared to placebo.
This will be evaluated by looking at the Geometric mean titre (GMT) of the serum antibody response to the Sclamp antigen compared to placebo by antigen specific Enzyme-linked immunosorbent assay (ELISA).
Timepoint [2] 323859 0
Blood samples will be collected for analysis at Day 29 (28 days after first dose) and Day 57 (28 days after second dose).
An interim analysis will be conducted after the first vaccination (Day 29) for serum antibody responses by ELISA, with the complete immunogenicity analysis at the conclusion of the active study period (Day 57).
Primary outcome [3] 324076 0
To assess the neutralizing antibody (NAb) immune responses elicited by SARS-CoV-2 Sclamp vaccine compared to placebo.
This will be evaluated by looking at the GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo by microneutralization (MN) assay
Timepoint [3] 324076 0
Blood samples will be collected for analysis at Day 29 (28 days after first dose) and Day 57 (28 days after first dose).
A complete immunogenicity analysis will be performed at the conclusion of the active study period (Day 57).
Secondary outcome [1] 383075 0
To compare the total serum antibody immune responses compared to placebo, to be done by looking at the GMT of the serum antibody response to the Sclamp antigen compared to placebo by antigen specific ELISA at Days 1, 15, 29 (28 days after the first dose) and Days 43, 57 (28 days after the second dose) and Days 209 and 394 (6 and 12 months post second dose respectively).
Timepoint [1] 383075 0
Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination.
An interim analysis will be conducted after the first vaccination (Day 29) for serum antibody responses by ELISA, with the complete immunogenicity analysis at the conclusion of the active study period (Day 57).
Secondary outcome [2] 383686 0
To compare the total serum antibody immune responses compared to placebo, to be done by determining the proportion of participants with greater than or equal to 4 fold increase in titre above baseline by ELISA. (serum antibody) at Days 15, 29, 43, 57, 209 and 394 post-vaccination compared to placebo.
Timepoint [2] 383686 0
Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination.
An interim analysis will be conducted after the first vaccination (Day 29) for serum antibody responses by ELISA, with the complete immunogenicity analysis at the conclusion of the active study period (Day 57).
Secondary outcome [3] 383687 0
To compare the NAb immune responses compared to placebo, to be done by determining the proportion of participants with greater than or equal to 4 fold increase in titre above baseline by MN assay (NAb) at Days 15, 29, 43, 57, 209 and 394 post-vaccination compared to placebo.
Timepoint [3] 383687 0
Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination. A complete immunogenicity analysis will be performed at the conclusion of the active study period (Day 57).
Secondary outcome [4] 383688 0
To compare the total NAb immune responses compared to placebo, to be done by looking at the GMT of the serum neutralizing antibody (NAb) titres to SARS-CoV-2 virus compared to placebo by MN assay at Days 1, 15, 29 (28 days after the first dose) and Days 43, 57 (28 days after the second dose) and Days 209 and 394 (6 and 12 months post second dose respectively).
Timepoint [4] 383688 0
Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination. A complete immunogenicity analysis will be performed at the conclusion of the active study period (Day 57).

Eligibility
Key inclusion criteria
1. Healthy male or non-pregnant female, greater than or equal to 18 and less than or equal to 55 years of age, with BMI greater than 18 and less than 34.0 kg/metres sqaured and body weight greater than or equal to 50.0 kg for males and greater than or equal to 45.0 kg for females.
2. Healthy as defined by:
a.The absence of clinically significant illness and surgery within 28 days prior to dosing. Subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. Inclusion is at the discretion of the Investigator, and the subject may have their scheduled dosing postponed until the condition resolves.
b.The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3.Non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). Ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 1 year.
4.Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 2 highly effective methods of contraception commencing at least 28 days prior to enrolment, during the study and for 3 months after last treatment administration. A female subject is considered to be a WOCBP following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). A follicle-stimulating hormone (FSH) test may be used to confirm postmenopausal state. Examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include:
a. Simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment (active or placebo) administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
b. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner;
c. Simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration;
d. Sterile male partner (vasectomized since at least 6 months prior to first study treatment administration);
e. True abstinence, defined as no sexual intercourse (heterosexual couples), for at least 28 days prior to first study treatment administration and for at least the duration of the study. Periodic abstinence and withdrawal are not acceptable methods.
5. WOCBP must have a negative urine pregnancy test (and negative serum pregnancy test in the event of a positive urine test) prior to receiving each dose.
6. Male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration.
7. Male subjects must be willing not to donate sperm until 90 days following the last study treatment administration.
8. Must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule.
9. Capable of, and have given, written consent.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormality or vital sign abnormality at physical examination, including baseline high blood pressure (140/90), after 3 repeated measurements and high random blood sugar(non fasting), clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
2. Any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject’s participation.
3. Any subject that has an active COVID-19 infection (positive COVID-19 test: nasal/oropharyngeal swab and/or positive serum antibody response) at screening, and Day 1, has been in close contact with someone who has an active COVID-19 infection, or has recovered from a previous COVID-19, SARS-CoV1 or MERS infection.
4. Positive pregnancy, urine drug screen, or alcohol breath test at screening.
5. Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in the formulation (including the adjuvant).
6. Presence of a known, or suspected, impairment of the immune system including, but not limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus.
7. History of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or asthma.
8. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit.
9. Positive test for drugs of abuse (such as marijuana/tetrahydrocannabinol [THC] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine [MDMA], or phencyclidine [PCP]) at screening, prior to dosing, or a history of drug abuse within 1 year prior to screening.
10. Participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the first treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study.
11. Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged to interfere with subject safety (e.g., topical drug products without significant systemic absorption are permissible):
a. Prescription medication within 14 days prior to the first dosing;
b. Any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs known to be frequently associated with signficant major organ toxicity with 90 days prior to enrolment;
c. Any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the second dose of the study vaccine
d. Any other investigational coronoavirus vaccine i.e. SARSCoV-1, SARSCoV-2, MERS etc. at any time prior to, or during, the study.
e. Over-the-counter products within 7 days prior to the first dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins.
12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
13. Receipt of blood products within 2 months prior to the first study treatment administration (Day 1), or planned receipt of blood products during the study period.
14. Breast-feeding subject, or subject who plans to breastfeed from the time of first dose through 60 days after last study treatment administration.
15. Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the injection site which, in the opinion of the Investigator, may inhibit the ability to effectively perform an injection site assessment.
16. Employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or Syneos Health.
17. Any reason which, in the opinion of the Investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is the off-site pharmacist with no contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
It is planned to enroll approximately 120 male and female volunteers for participation in this study.
No prospective calculations of statistical power have been made, since no statistical hypothesis is associated with the objectives of the study. The sample size of 24 subjects per treatment group has been selected to provide information on safety and estimates related to the primary and secondary endpoints

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16721 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 30323 0
4007 - Herston

Funding & Sponsors
Funding source category [1] 305763 0
University
Name [1] 305763 0
University of Queensland
Address [1] 305763 0
School of Chemistry & Molecular Biosciences
Building 68, St Lucia QLD 4072
Country [1] 305763 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Chemistry & Molecular Biosciences
Building 68, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 306199 0
None
Name [1] 306199 0
Address [1] 306199 0
Country [1] 306199 0
Other collaborator category [1] 281326 0
Other Collaborative groups
Name [1] 281326 0
Coalition for Epidemic Preparedness Innovations (CEPI)
Address [1] 281326 0
Marcus Thranes gate 2, 0473 Oslo
Country [1] 281326 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306036 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 306036 0
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 306036 0
Australia
Date submitted for ethics approval [1] 306036 0
27/05/2020
Approval date [1] 306036 0
07/07/2020
Ethics approval number [1] 306036 0

Summary
Brief summary
This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102502 0
Dr Paul Griffin
Address 102502 0
Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD
Country 102502 0
Australia
Phone 102502 0
+61 402077302
Fax 102502 0
Email 102502 0
p.griffin@nucleusnetwork.com.au
Contact person for public queries
Name 102503 0
Dr Paul Griffin
Address 102503 0
Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD
Country 102503 0
Australia
Phone 102503 0
+61 402077302
Fax 102503 0
Email 102503 0
p.griffin@nucleusnetwork.com.au
Contact person for scientific queries
Name 102504 0
Dr Paul Griffin
Address 102504 0
Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD
Country 102504 0
Australia
Phone 102504 0
+61 402077302
Fax 102504 0
Email 102504 0
p.griffin@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by sponsor, University of Queensland (UQ)
Contact rapid.response.trials@uq.edu.au
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 8021 0
Clinical study report
Citation [1] 8021 0
Link [1] 8021 0
Email [1] 8021 0
rapid.response.trials@uq.edu.au
Other [1] 8021 0
Attachment [1] 8021 0
Summary results
No Results