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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05272605




Registration number
NCT05272605
Ethics application status
Date submitted
3/03/2022
Date registered
9/03/2022

Titles & IDs
Public title
Safety and Immune Response of Adjuvanted SARS-CoV-2 (COVID-19) Beta Variant RBD Recombinant Protein (DoCo-Pro-RBD-1 + MF59®) and mRNA (MIPSCo-mRNA-RBD-1) Vaccines in Healthy Adults
Scientific title
A Phase I, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Adjuvanted SARS-CoV-2 (COVID-19) Beta Variant RBD Recombinant Protein (DoCo-Pro-RBD-1 + MF59®) and mRNA (MIPSCo-mRNA-RBD-1) Vaccines in Healthy Adults Aged 18 to 64 Years Previously Vaccinated With 3 Doses of Licensed SARS-CoV-2 Ancestral Strain Vaccines
Secondary ID [1] 0 0
UoM-SARS-CoV-2-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)
Treatment: Other - SARS-CoV-2 beta variant RBD mRNA vaccine
Other interventions - Normal Saline

Experimental: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 5mcg + MF59 - DoCo-Pro-RBD-1 antigen 5mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered intramuscularly in a one dose regimen, on Day 1

Experimental: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1)15mcg + MF59 - DoCo-Pro-RBD-1 antigen 15mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered intramuscularly in a one dose regimen, on Day 1

Experimental: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 45mcg + MF59 - DoCo-Pro-RBD-1 antigen 45mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered intramuscularly in a one dose regimen, on Day 1

Experimental: SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 10mcg - MIPSCo-mRNA-RBD-1 antigen 10mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1

Experimental: SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 20mcg - MIPSCo-mRNA-RBD-1 antigen 20mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1

Experimental: SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 50mcg - MIPSCo-mRNA-RBD-1 antigen 50mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1

Placebo comparator: Normal saline (0.9%) - Normal saline (0.9%) administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1


Treatment: Other: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)
Single booster dose in healthy adults previously vaccinated with two doses of CominartyTM (BNT162b2 \[mRNA\]) or VaxzevriaTM (ChAdOx1-S) COVID-19 and a third booster dose of either ComirnatyTM or SpikevaxTM vaccines.

Treatment: Other: SARS-CoV-2 beta variant RBD mRNA vaccine
Single booster dose in healthy adults previously vaccinated with two doses of CominartyTM (BNT162b2 \[mRNA\]) or VaxzevriaTM (ChAdOx1-S) COVID-19 and a third booster dose of either ComirnatyTM or SpikevaxTM vaccines.

Other interventions: Normal Saline
Placebo comparator
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 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.
Timepoint [1] 0 0
Through to study completion at Day 181.
Primary outcome [2] 0 0
SAEs post vaccination.
Timepoint [2] 0 0
Day 1 to 29 (28 Days post vaccination).
Primary outcome [3] 0 0
Solicited local and systemic reactogenicity AEs post vaccination.
Timepoint [3] 0 0
Within 7 days after vaccination (Day 1)
Primary outcome [4] 0 0
Unsolicited AEs post vaccination.
Timepoint [4] 0 0
Day 1 to Day 29 (28 days post vaccination).
Primary outcome [5] 0 0
Percentage of participants who achieve a boost response post vaccination.
Timepoint [5] 0 0
28 days after vaccination
Secondary outcome [1] 0 0
MAAEs from Day 1 to 6 months after vaccination.
Timepoint [1] 0 0
6 months after vaccination.
Secondary outcome [2] 0 0
The number of participants that develop an antibody response at least 4 times higher than baseline antibody titers.
Timepoint [2] 0 0
At baseline (Day 1), Day 29 (28 days after vaccination), and 3, and 6 months after vaccination
Secondary outcome [3] 0 0
Number of participants that mount a T cell response for SARS-CoV-2 RBD-derived peptide antigens.
Timepoint [3] 0 0
Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
Secondary outcome [4] 0 0
Number of participants that mount a T cell response that leads to type-1 cytokines (such as Interferon-gamma) versus type-2 cytokines (such as Interleukin 4, 5 and 13).
Timepoint [4] 0 0
Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
Secondary outcome [5] 0 0
The ratio of T cell derived type 1 versus type 2 cytokines in participants that mount a T cell response.
Timepoint [5] 0 0
Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.

Eligibility
Key inclusion criteria
Inclusion criteria:

To be eligible for this study, participants must meet ALL of the following inclusion criteria:

1. Adults 18 to 64 years of age, inclusive at screening previously vaccinated with a 2-dose schedule of Cominarty™ or Vaxzevria™.
2. = 3 months (90 days) since receipt of a booster dose of either ComirnatyTM or SpikevaxTM.
3. Be in good health as determined by medical history, physical examination, vital signs, and clinical laboratory assessments with no clinically significant abnormalities as judged by the Investigator at screening and randomisation. Vital signs must be within medically acceptable ranges prior to the first vaccination.
4. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea of at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study:

a. Condoms (male or female); Diaphragm; Cervical cap; Intrauterine device; Oral or patch contraceptives; Norplant®, Depo-Provera®, or another regulatory approved contraceptive method; Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle.
5. NOTE: Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post- ovulation methods) and withdrawal method (coitus interruptus) are not acceptable forms of contraception.
6. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
7. Willing and able to give informed consent prior to study enrollment and to comply with all study procedures.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

Potential study participants will be excluded from the study if ANY of the following criteria apply:

1. History of test-confirmed (by PCR, rapid antigen test (RAT) to SARS-CoV-2) COVID-19 infection within 3 months (90 days) prior to randomisation.
2. Participants with a BMI > 35kg/m2.
3. Positive result for rheumatoid factor (RF) at Screening.
4. Positive test at Screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen or hepatitis C virus antibody.
5. Clinical laboratory test results not within normal range and judged to be clinically relevant abnormalities by the investigator.
6. History of prior cardiac inflammatory disease (endocarditis, myocarditis or pericarditis).
7. History of demyelinating disease or Guillain Barré syndrome.
8. Fever (non-axillary temperature >37.5°C) or any other symptoms of infection that have not completely resolved within 3 days prior to Randomisation (Day 1).
9. Presence of current active viral infection or bacterial infection, at Screening or Randomisation (Day 1), which is determined by the Investigator to be of clinical significance.
10. Participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination or an intention to participate in another clinical trial at any time during the conduct of this study.
11. Received any other vaccine within 30 days prior to the first study vaccination, other than licensed influenza vaccine, which can be administered up to 14 days prior to randomization.
12. Any known allergies to products contained in the investigational products.
13. Any history of anaphylaxis to any prior vaccine, food, drug, toxin or other exposure.
14. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.

NOTE: Stable endocrine disorders (e.g., thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis) are NOT excluded.
15. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.

NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose = 10mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
16. Received immunoglobulin, blood-derived products, or immunosuppressant drugs or donation of blood/blood products within 90 days prior to vaccination or planned receipt or donation during the study period.
17. Thrombocytopaenia, contraindicating intramuscular vaccination, based on the Investigator's judgment.
18. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgement.
19. Active cancer (malignancy) on therapy within one year prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo malignancy and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the Investigator).
20. Participants who are breastfeeding, pregnant or who plan to become pregnant prior to the end of study.
21. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the Investigator, might interfere with protocol compliance.
22. Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may, in the Investigator's opinion, interfere with injection site assessments.
23. Any other condition that, in the opinion of the Investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
24. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization (CRO), and study site personnel involved in the conduct or planning of the study).
25. Aboriginal and Torres Strait Islander person aged 50 years or older.

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
Other
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
5/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2023
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Vaccine and Immunisation Research Group, Doherty Institute, University of Melbourne - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital, Victorian Infectious Diseases Service (VIDS) - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Southern Star Research Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Terry Nolan
Address 0 0
Peter Doherty Institute for Infection and Immunity, The University of Melbourne
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05272605