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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04495933




Registration number
NCT04495933
Ethics application status
Date submitted
13/07/2020
Date registered
3/08/2020
Date last updated
23/04/2021

Titles & IDs
Public title
A Study on the Safety, Tolerability and Immune Response of SARS-CoV-2 Sclamp (COVID-19) Vaccine in Healthy Adults
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 in Healthy Adults Aged 18 to 55 Years Old and Healthy Older Adults, Aged 56 Years and Over
Secondary ID [1] 0 0
ACTRN12620000674932p
Secondary ID [2] 0 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:
SARS-CoV2 0 0
Covid19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg
Other interventions - MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg
Other interventions - MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg
Other interventions - Placebo

Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg - SARS-CoV-2 Sclamp antigen 5 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart.(Cohorts 1 & 4)

Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg - SARS-CoV-2 Sclamp antigen 15 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart. (Cohorts 2 & 5)

Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg - SARS-CoV-2 Sclamp antigen 45 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart. (Cohorts 3 & 6)


Other interventions: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg

Other interventions: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg

Other interventions: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg

Other interventions: Placebo
sterile saline

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Solicited local reactogenicity adverse events (AEs) - - the frequency of solicited local reactogenicity adverse events (AEs)
Timepoint [1] 0 0
7 days following each vaccination (at Days 1 and 29)
Primary outcome [2] 0 0
Frequency of Solicited systemic reactogenicity adverse events (AEs) - - the frequency of solicited systemic reactogenicity AEs
Timepoint [2] 0 0
7 days following each vaccination (at Days 1 and 29)
Primary outcome [3] 0 0
Grading of Solicited local reactogenicity adverse events (AEs) - - the grading of solicited local reactogenicity adverse events (AEs)
Timepoint [3] 0 0
7 days following each vaccination (at Days 1 and 29)
Primary outcome [4] 0 0
Grading of Solicited systemic reactogenicity adverse events (AEs) - - the grading of solicited systemic reactogenicity AEs
Timepoint [4] 0 0
7 days following each vaccination (at Days 1 and 29)
Primary outcome [5] 0 0
Unsolicited adverse events (AEs) - - the frequency, duration, intensity and relationship to vaccination of unsolicited local adverse events (AEs)
Timepoint [5] 0 0
28 days following each vaccination (at Days 1 and 29)
Primary outcome [6] 0 0
Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study - - the frequency, duration, intensity and relationship to vaccination of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study (including decision by the Principal Investigator [PI] not to proceed with the second dose) at any time during the study
Timepoint [6] 0 0
through study completion (394 days)
Primary outcome [7] 0 0
Geometric Mean Titer (GMT) of the serum antibody response - - Geometric mean titre (GMT) of the serum antibody response compared to placebo
Timepoint [7] 0 0
28 days following each vaccination (Days 29 and 57)
Primary outcome [8] 0 0
Geometric Mean Titer (GMT) of the serum neutralizing antibody (NAb) response to SARS-CoV-2 virus - GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo
Timepoint [8] 0 0
28 days following each vaccination (Days 29 and 57)
Secondary outcome [1] 0 0
Total serum antibody immune responses - GMT of the serum antibody response compared to placebo
Timepoint [1] 0 0
through study completion (394 days)
Secondary outcome [2] 0 0
proportion of participants with = 4 fold increase in titer above baseline - proportion of participants with greater than or equal to 4 fold increase in titre above baseline compared to placebo.
Timepoint [2] 0 0
through study completion (394 days)
Secondary outcome [3] 0 0
GMT of the serum neutralizing antibody (NAb) titres - GMT of the serum neutralizing antibody (NAb) immune responses compared to placebo
Timepoint [3] 0 0
through study completion (394 days)

Eligibility
Key inclusion criteria
- Healthy male or non-pregnant female, =18 and =55 years of age, with BMI >18 and <34.0
kg/m2 and body weight =50.0 kg for males and =45.0 kg for females (Part 1); Healthy
male or non-pregnant female, =56 years of age, with BMI >18 and <34.0 kg/m2 and body
weight =50.0 kg for males and =45.0 kg for females (Part 2)

- Healthy as defined by:

1. 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 pre-dosing is
at the discretion of the Investigator, and the subject may have their scheduled
dosing postponed until the condition resolves.

2. The absence of clinically significant history of neurological, endocrine,
cardiovascular, respiratory, haematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease (Part 1); b. The absence
of clinically significant history of a pre-existing medical condition that is not
stable (neurological, endocrine, cardiovascular, respiratory, haematological,
immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic
disease). A stable medical condition is defined as disease not requiring
significant change in therapy or hospitalization for worsening disease during the
3 months before enrolment (Part 2)

- 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 12 months.

- 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 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 postmenopausal 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 post-menopausal state.
Examples of acceptable methods of contraceptive methods (for female subjects) to be
used throughout the study include:

1. Simultaneous use of hormonal contraceptives, started at least 28 days prior to
first study treatment administration and must agree to use the same hormonal
contraceptive throughout the study, and condom for the male partner;

2. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days
prior to first study treatment administration, and condom for the male partner;

3. 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;

4. Sterile male partner (vasectomized since at least 6 months prior to first study
treatment administration);

5. True abstinence, defined as no sexual intercourse with a male partner, (for
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.

- WOCBP must have a negative urine pregnancy test prior to receiving each dose.

- 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.

- Male subjects must be willing not to donate sperm until 90 days following the last
study treatment administration.

- 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.

- Capable of, and have given, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any clinically significant abnormality or vital sign abnormality at physical
examination (including baseline high blood pressure [140/90] after 3 repeated
measurements or 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 (Part 1); Any clinically significant abnormality or
vital sign abnormality at physical examination, or uncontrolled hypertension in adults
aged = 56 years and older ,or 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 (Part 2).

- Any acute or chronic ongoing illness which, in the judgement of the investigator, may
preclude the subject's participation.

- Any subject that has an active COVID-19 infection (positive COVID-19 test:
nasal/oropharyngeal swab and/or positive serum antibody response) at screening, or Day
1, or has been in close contact with someone who has an active COVID-19 infection, or
has recovered from a previous COVID-19, SARS-CoV-1, or MERS infection.

- Positive pregnancy, urine drug screen, or alcohol breath test at screening.

- Known history of allergic reactions or hypersensitivity to vaccines, or to any
excipient in the formulation (including the adjuvant, MF59C.1).

- Presence of a known, or suspected, impairment of the immune system including, but not
limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes
mellitus.

- 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, excluding childhood asthma
(Part 1); History of a known, or suspected, or currently unstable medical condition
that may expose the participant to an increased risk for severe SARS-CoV-2 disease,
such as a respiratory system disorder including, but not limited to, cystic fibrosis,
reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary
disease (COPD), or asthma, excluding childhood asthma, uncontrolled hypertension,
ischemic or structural heart disease, chronic kidney disease, chronic liver disease,
endocrine disorder and neurological illness (Part 2).

- History of significant alcohol abuse within 12 months prior to screening.

- 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 12 months prior to
screening.

- 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.

- 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:

1. Prescription medication within 14 days prior to the first dosing (Part 1);
Prescription medication within 14 days prior to the first dosing that in the
opinion of the Investigator could impact the subjects safe participation in the
study (Part 2)

2. 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 significant major organ
toxicity within 90 days prior to enrolment;

3. 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

4. Any other investigational coronavirus vaccine i.e. SARS-CoV-1, SARS-CoV-2, MERS
etc. at any time prior to, or during, the study.

5. 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 (Part 1); Over-the-counter products within 7 days prior to the
first dosing, that in the opinion of the investigator could impact the subjects
safe participation in the study. Paracetamol (up to 2 g daily) and standard dose
vitamins will be permitted (Part 2).

- 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.

- 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.

- Breast-feeding subject, or subject who plans to breastfeed from the time of first dose
through 60 days after last study treatment administration.

- 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.

- Employee or immediate relative of an employee of the clinical site, any of its
affiliates or partners, or Syneos Health.

- 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.

- Permanent resident in an aged care facility (nursing or aged care home) (Part 2 only)

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)
Methods used to generate the sequence in which subjects will be randomised (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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
Nucleus Network Brisbane (Q-Pharm Pty Ltd) - Herston
Recruitment postcode(s) [1] 0 0
4007 - Herston

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Coalition for Epidemic Preparedness Innovations
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/show/NCT04495933
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Griffin, Dr
Address 0 0
Nucleus Network Brisbane
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Griffin, Dr
Address 0 0
Country 0 0
Phone 0 0
+61402077302
Fax 0 0
Email 0 0
p.griffin@nucleusnetwork.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04495933