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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05775887




Registration number
NCT05775887
Ethics application status
Date submitted
8/03/2023
Date registered
20/03/2023
Date last updated
6/03/2024

Titles & IDs
Public title
A FIRST IN HUMAN TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-CoV-2 UQSC2 VACCINE IN HEALTHY ADULTS.
Scientific title
A PHASE 1 RANDOMIZED, ACTIVE-CONTROLLED, DOUBLEBLIND, SINGLE CENTRE STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF AN ADJUVANTED SARS-CoV-2 UQSC2 PROTEIN SUBUNIT VACCINE IN HEALTHY ADULTS, AGED 18 TO 50 YEARS.
Secondary ID [1] 0 0
UQ-2-UQSC2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - UQSC2 Vaccine
Other interventions - NVX-CoV2373 vaccine

Experimental: UQSC2 vaccine - 15mcg of UQSC2 (SARS-CoV-2 Sclamp2 antigen) adjuvanted with MF59

Active Comparator: NVX-CoV2373 vaccine - 5 mcg SARS-CoV-2 spike protein adjuvanted with Matrix-M


Other interventions: UQSC2 Vaccine
Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373. The Study will be unblinded after Day 29, to enable subjects who received the investigational vaccine (UQSC2 vaccine) to seek vaccination with a TGA (Therapeutic Goods Administration) approved COVID-19 booster vaccine if indicated by public health authorities.

Other interventions: NVX-CoV2373 vaccine
Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency, duration, and intensity of solicited local adverse events (AEs)
Timepoint [1] 0 0
[Time Frame: Day 1-7]
Primary outcome [2] 0 0
Frequency, duration, and intensity of solicited systemic adverse events (AEs)
Timepoint [2] 0 0
[Time Frame: Day 1-7]
Primary outcome [3] 0 0
Frequency, duration, and intensity of solicited systemic adverse events (AEs)
Timepoint [3] 0 0
[Time Frame: Day 1-29]
Primary outcome [4] 0 0
Frequency of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest and any AEs leading to study withdrawal at any time
Timepoint [4] 0 0
[Time Frame: Dat 1-183]
Primary outcome [5] 0 0
Geometric Mean Titres (GMT) of the serum NAb (Neutralising Antibody) titres to matched SARS-CoV-2 (prototypic strain) by microneutralisation (MN) assay.
Timepoint [5] 0 0
[Time Frame: At Day 29]
Primary outcome [6] 0 0
Seroresponse rate (SRR), where seroresponse is defined as = 4-fold rise from pre-vaccination, Day 1) by MN assay to matched SARS-CoV-2 (prototypic strain).
Timepoint [6] 0 0
[Time Frame: At Day 29]
Secondary outcome [1] 0 0
GMT of the serum antibody response by SARS-CoV-2 Spike antigen specific ELISA
Timepoint [1] 0 0
[Time Frame: At Day 29]
Secondary outcome [2] 0 0
Seroresponse rate (SRR, where seroresponse is defined as = 4-fold rise from pre-vaccination, Day 1) by ELISA
Timepoint [2] 0 0
[Time Frame: At Days 15, 29, 91 and 183]
Secondary outcome [3] 0 0
SRR by MN assay at Days 15, 29, 91 and183, compared to NVX-CoV2373
Timepoint [3] 0 0
[Time Frame: At Days 15, 29, 91 and 183]
Secondary outcome [4] 0 0
GMT to the SARS-CoV-2 Spike by antigen specific ELISA
Timepoint [4] 0 0
[Time Frame: At Days 1,15, 29, 91 and 183]
Secondary outcome [5] 0 0
GMT of the serum NAb titres to matched SARS-CoV-2 (prototypic strain) by MN assay
Timepoint [5] 0 0
[Time Frame: At Days 1,15, 29, 91 and 183]

Eligibility
Key inclusion criteria
1. Healthy male or non-pregnant female, =18 and =50 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.

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 (at least 3 symptom-free pre-dose days required) will be
carefully evaluated for upcoming illness/disease. Inclusion of 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.

3. Non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes
per week). Ex-heavy smokers (heavy smoking is 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.
Ex-moderate level smokers (i.e. >10 per week but <25 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 6 months.

4. All women of child bearing potential (WOCBP) and men must refrain from sperm/egg
donation and must be able and willing to use at least 1 highly effective method of
contraception commencing at least 28 days prior to vaccine administration and for 3
months after vaccine administration. Subjects in same sex relationships must be able
and willing to refrain from sperm/egg donation for 3 months after vaccine
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 a post-menopausal
state. Examples of acceptable methods of contraceptive methods (for female subjects
and female partners of male subjects) to be used throughout the study include

1. Use of hormonal contraceptives, started at at least 28 days prior to study
treatment administration and must agree to use the same hormonal contraceptive
throughout the study;

2. Use of an intra-uterine contraceptive device, placed at at least 28 days prior to
study treatment administration;

3. Use of a diaphragm, started at least 28 days prior to study treatment
administration;

4. Use of condoms for male subjects whose partners are pregnant to ensure that the
foetus is not exposed to the study vaccine;

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

6. True abstinence, defined as no sexual intercourse with a male partner, (for
heterosexual couples) from the time of enrollment and at for at least 28 days
prior to study treatment administration and for at least the duration of the
study. Periodic abstinence and withdrawal are not acceptable methods.

5. Must meet the following COVID-19 vaccination status:

1. Have completed a primary SARS-CoV-2 vaccination series with either the Pfizer or
Moderna COVID-19 vaccine, and

2. Have received at least one booster dose of the Pfizer or Moderna SARS-CoV-2
vaccine at least 3 months prior to study entry.

6. WOCBP must return a negative urine pregnancy test prior to receiving the study
treatment.

7. 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 study treatment administration until at least 90 days after the last
study treatment administration.

8. Must be willing to refrain from blood (and plasma) donation throughout study
participation.

9. Must be able to attend all visits for the duration of the study and comply with all
study procedures according to the study schedule.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects to whom any of the following applies will be excluded from the study:

1. Any clinically significant abnormality or vital sign abnormality at physical
examination (including baseline resting average high blood pressure [average systolic
blood pressure =140 mmHg or resting average diastolic blood pressure =90 mmHg or high
random blood sugar [nonfasting]), 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. Subjects who have a chronic condition that is
stable and controlled and otherwise healthy should not be excluded. Within at least
the past 3 months must NOT have received another COVID-19 vaccine.

3. Persons who received another COVID-19 vaccine within the past 3 months prior to
dosing.

4. Persons who received a primary vaccination series and or a booster vaccination dose of
a non-mRNA COVID-19 vaccine (ie Matrix M adjuvanted COVID-19 vaccine, Novavax).

5. Persons who have a history of COVID-19 or virologically confirmed SARS-CoV-2 infection
in the past 3 months.

6. Persons with a history of COVID-19 with ongoing sequelae.

7. Persons with a history of myocarditis and/or pericarditis.

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

9. Known history of allergic reactions or hypersensitivity to any vaccine, or to any
excipient in the formulation (including the adjuvants: MF59C.1 and Matrix-M).

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

11. 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.

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

13. 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 12months prior to
screening.

14. Participation in a clinical research study involving the administration of an
investigational, or marketed, drug or device within 30 days prior to receiving the
treatment administration, or administration of a biological product in the context of
a clinical research study within 90 days prior to dosing, or concomitant participation
in an investigational study involving drug, vaccine, or device administration, or
intent to participate in another clinical study at any time during the conduct of the
study.

15. Use of medications for the timeframes specified below, (except for 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. A new, or a change in a prescription medication within 14 days prior to treatment
administration;

2. Any medication, or treatments, that may affect the immune system such as allergy
injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or
other drugs are 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 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 dosing, with the exception of
the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins.

16. 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 dosing.

17. Receipt of blood products within 2 months prior to vaccine administration (Day 1), or
planned receipt of blood products during the study period (Screening through Day 29).

18. Breast-feeding subjects, or subjects who plan to breastfeed from the time of the
vaccination through 60 days after the treatment administration.

19. Presence of tattoos, scarring, skin discolouration, 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.

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

21. Employees of the specific team at the University of Queensland responsible for
manufacturing and managing the IP (Investigational Product) or their immediate
relatives.

22. Any reason that, 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)
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2023
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QPharm Pty.Ltd. (Nucleus Network Brisbane) - Herston
Recruitment postcode(s) [1] 0 0
4006 - 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
Coalition for Epidemic Preparedness Innovations
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This will be a single centre, Phase 1, First-In-Human , Randomized, Active-controlled (2-
arm) Double-blind, single dose, parallel design study. The study will be conducted in a young
healthy adult population aged = 18 - = 50 years. This study will consist of a single cohort
of 70 subjects (35 receiving a single dose of UQSC2 vaccine and 35 subjects receiving a
single dose of a TGA (Therapeutic Goods Administration) registered SARS-CoV-2 vaccine
NVX-CoV2373).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05775887
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristi Mclendon
Address 0 0
Nucleus Network Pty Ltd Brisbane
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries