SARS-CoV-2Phase 1NCT05272605

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

A Phase 1 study testing Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59), SARS-CoV-2 beta variant RBD mRNA vaccine and Normal Saline in people with SARS-CoV-2, run by University of Melbourne at 2 sites 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

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
What is being tested?: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59), SARS-CoV-2 beta variant RBD mRNA vaccine and Normal Saline
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 2 sitesAustralia
Study dates: 5 Apr 2022to 19 Apr 2023
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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

To be eligible for this study, participants must meet ALL of the following inclusion criteria:
Adults 18 to 64 years of age, inclusive at screening previously vaccinated with a 2-dose schedule of Cominarty™ or Vaxzevria™.
≥ 3 months (90 days) since receipt of a booster dose of either ComirnatyTM or SpikevaxTM.
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.
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:
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.

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NOTE: Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post- ovulation methods) and withdrawal method (coitus interruptus) are not acceptable forms of contraception.
Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
Willing and able to give informed consent prior to study enrollment and to comply with all study procedures.

Who cannot join

Potential study participants will be excluded from the study if ANY of the following criteria apply:
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.
Participants with a BMI > 35kg/m2.
Positive result for rheumatoid factor (RF) at Screening.
Positive test at Screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen or hepatitis C virus antibody.
Clinical laboratory test results not within normal range and judged to be clinically relevant abnormalities by the investigator.

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History of prior cardiac inflammatory disease (endocarditis, myocarditis or pericarditis).
History of demyelinating disease or Guillain Barré syndrome.
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).
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.
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.
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.
Any known allergies to products contained in the investigational products.
Any history of anaphylaxis to any prior vaccine, food, drug, toxin or other exposure.
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.
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.
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.
Thrombocytopaenia, contraindicating intramuscular vaccination, based on the Investigator's judgment.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgement.
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).
Participants who are breastfeeding, pregnant or who plan to become pregnant prior to the end of study.
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.
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.
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).
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).
Aboriginal and Torres Strait Islander person aged 50 years or older.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Vaccine and Immunisation Research Group, Doherty Institute, University of Melbourne
Melbourne, Victoria, 3010
Royal Melbourne Hospital, Victorian Infectious Diseases Service (VIDS)
Melbourne, Victoria, 3052

Other trials in Australia

About this study

Official 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

This is a study of two experimental SARS-CoV-2 vaccines against the virus called SARS-CoV-2 virus. The first of the experimental vaccines is called DoCo-Pro-RBD-1 + M59® and contains a laboratory made protein which looks the same as a protein in the SARS-CoV-2 virus. As this protein is so similar to a protein in the SARS-CoV-2 virus, it allows the immune system to develop immunity against the real virus by producing specific antibodies against this protein. Antibodies are substances in the blood which could help protect against future infection. The second of the experimental vaccines that will be tested is called MIPSCo-mRNA-RBD-1. This type of vaccine uses messenger ribonucleic acid (mRNA) which is a set of instructions for a cell to make a viral protein called an antigen. Antigens are substances that can trigger the body's defences to produce antibodies that fight against the disease.

This study will test these two experimental COVID-19 vaccines in people who have previously received two doses of ComirnatyTM (Pfizer Australia Pty Ltd) or VaxzevriaTM (AstraZeneca Pty Ltd) and a third booster vaccination with either ComirnatyTM or SpikevaxTM (Moderna). This study is the first time this recombinant protein vaccine and this mRNA vaccine will be given to humans. The purpose of this study is to determine what amount, or dose, of the experimental vaccines is safe and produces the desired immune response and antibody level for future investigations. It will do this by testing 3 different dose levels for each of the two vaccines. Each participant will receive a single vaccine at one of the three dose levels, or a placebo injection. This study is the first time this recombinant protein vaccine and this mRNA vaccine will be given to humans.

Read the detailed description

This is a randomised, double-blind, placebo-controlled, dose-escalation, first-in-human study to assess the safety, reactogenicity and immunogenicity of SARS-CoV-2 beta variant DoCo-Pro-RBD-1 + MF59® and MIPSCo-mRNA-RBD-1 vaccine at three dose levels, administered intramuscularly (IM) as a 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. The study will comprise a Dose-Escalation Phase and an Expanded Phase.

The study vaccines, DoCo-Pro-RBD-1 + MF59®, MIPSCo-mRNA-RBD-1 or placebo (normal saline) will be administered IM in the deltoid region of the upper arm.

The study will enroll healthy adults aged 18 to 64 years of age inclusive. Participants in both the Dose-Escalation Phase and Expanded Phase of the study will be stratified by prior primary course COVID-19 vaccination with CominartyTM or VaxzevriaTM.

Conditions: SARS-CoV-2
Being tested: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59), SARS-CoV-2 beta variant RBD mRNA vaccine, Normal Saline
Keywords: COVID-19
Medical subject headings: COVID-19

What participants receive

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

Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)Biological
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.
SARS-CoV-2 beta variant RBD mRNA vaccineBiological
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.
Normal SalineOther
Placebo comparator

Study groups in NCT05272605
Study group	Role	What they receive
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 5mcg + MF59	Experimental	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 Receives: Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1)15mcg + MF59	Experimental	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 Receives: Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 45mcg + MF59	Experimental	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 Receives: Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59)
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 10mcg	Experimental	MIPSCo-mRNA-RBD-1 antigen 10mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1 Receives: Biological: SARS-CoV-2 beta variant RBD mRNA vaccine
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 20mcg	Experimental	MIPSCo-mRNA-RBD-1 antigen 20mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1 Receives: Biological: SARS-CoV-2 beta variant RBD mRNA vaccine
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 50mcg	Experimental	MIPSCo-mRNA-RBD-1 antigen 50mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1 Receives: Biological: SARS-CoV-2 beta variant RBD mRNA vaccine
Normal saline (0.9%)	Placebo comparator	Normal saline (0.9%) administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1 Receives: Other: Normal Saline

What is being measured

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

Serious adverse events (SAEs), medically attended adverse events (MAAEs) and any adverse events (AEs) leading to study withdrawal at any time during the study.
Frequency
Measured: Through to study completion at Day 181.
SAEs post vaccination.
Frequency
Measured: Day 1 to 29 (28 Days post vaccination).
Solicited local and systemic reactogenicity AEs post vaccination.
Frequency, severity, duration and peak intensity
Measured: Within 7 days after vaccination (Day 1)
Unsolicited AEs post vaccination.
Frequency
Measured: Day 1 to Day 29 (28 days post vaccination).
Percentage of participants who achieve a boost response post vaccination.
Defined as a 4-fold increase in SARS-CoV-2 neutralising or RBD-specific Ab titres from baseline.
Measured: 28 days after vaccination

Secondary outcomes (5)

MAAEs from Day 1 to 6 months after vaccination.
MeDRA classification, severity score and relatedness.
Measured: 6 months after vaccination.
The number of participants that develop an antibody response at least 4 times higher than baseline antibody titers.
Number of participants that develop an antibody response at least 4 times higher than baseline antibody titers (before injection of the vaccine candidate or placebo), as assessed using in vitro ELISA assays for binding of the SARS-CoV-2 RBD to ACE2, and neutralising antibody assays that measure the ability to block RBD binding to ACE-2 or the ability of virus to infect cells in vitro). The magnitude and durability of those antibody responses over time will also be used to indicate the strength of the response within each participant to each vaccine in each cohort, and in relation to which vaccine the participants had previously received, compared to those participants that received placebo.
Measured: At baseline (Day 1), Day 29 (28 days after vaccination), and 3, and 6 months after vaccination
Number of participants that mount a T cell response for SARS-CoV-2 RBD-derived peptide antigens.
Number of participants that develop a T cell response in the short term (Day 8) and in the longer term (Day 29, 3 and 6 months after vaccination) in response to the vaccine candidate compared to their baseline (Day 1) T cell responses. T cell responses will be measured by flow cytometry looking for activated CD4 and CD8 T cells, including the percentage of T cells that respond to peptide antigens derived from the SARS-CoV-2 RBD. The magnitude and durability of those T cell responses over time will also be used to indicate the strength of the response within each participant to each vaccine in each cohort, and in relation to which vaccine the participants had previously received, compared to those participants that received placebo.
Measured: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
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).
For participants that develop a T cell response, two types of T cell response will be assessed, based on whether the activated T cells produce the cytokine Interferon-gamma, indicative of a type 1 cytokine response, or Interleukins 4, 5 and 13, indicative of a type 2 cytokine response. Cytokines will be measured following T cell activation with SARS-CoV-2-derived peptide antigens in vitro, using assays for cytokines will include intracellular cytokine staining as measured by flow cytometry, and elispot, as measured by an elispot reader.
Measured: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
The ratio of T cell derived type 1 versus type 2 cytokines in participants that mount a T cell response.
For participants that develop a T cell response, the ratio of type 1 cytokine to type 2 cytokines, measured by intracellular cytokine staining and by ELISpot, will be determined for at each timepoint, compared to placebo controls and baseline responses.
Measured: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.

Timeline

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

5 Apr 202219 Apr 2023

First posted9 Mar 2022
Study start5 Apr 2022
Primary completion19 Apr 2023
Study completion19 Apr 2023

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 SARS-CoV-2Studies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05272605
Sponsor's protocol ID: UoM-SARS-CoV-2-01
Status last verified: May 2023
First submitted: 3 Mar 2022
Last updated: 15 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nolan TM, Deliyannis G, Griffith M, Braat S, Allen LF, Audsley J, Chung AW, Ciula M, Gherardin NA, Giles ML, Gordon TP, Grimley SL, Horng L, Jackson DC, Juno JA, Kedzierska K, Kent SJ, Lewin SR, Littlejohn M, McQuilten HA, Mordant FL, Nguyen THO, Soo VP, Price B, Purcell DFJ, Ramanathan P, Redmond SJ, Rockman S, Ruan Z, Sasadeusz J, Simpson JA, Subbarao K, Fabb SA, Payne TJ, Takanashi A, Tan CW, Torresi J, Wang JJ, Wang LF, Al-Wassiti H, Wong CY, Zaloumis S, Pouton CW, Godfrey DI. Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster. EBioMedicine. 2023 Dec;98:104878. doi: 10.1016/j.ebiom.2023.104878. Epub 2023 Nov 27.
PubMed 38016322

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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05272605
Acronym / sponsor ID: UoM-SARS-CoV-2-01
Conditions: SARS-CoV-2
Keywords: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of MelbourneUniversity, hospital or other
Collaborators: Southern Star Research
Study start: 5 Apr 2022 (actual)
Primary completion: 19 Apr 2023 (actual)
Study completion: 19 Apr 2023 (actual)
First posted: 9 Mar 2022 (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.

Detailed description

The study vaccines, DoCo-Pro-RBD-1 + MF59®, MIPSCo-mRNA-RBD-1 or placebo (normal saline) will be administered IM in the deltoid region of the upper arm.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 5mcg + MF59	Experimental	Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + 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
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1)15mcg + MF59	Experimental	Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + 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
Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 45mcg + MF59	Experimental	Biological: Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + 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
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 10mcg	Experimental	Biological: SARS-CoV-2 beta variant RBD mRNA vaccineMIPSCo-mRNA-RBD-1 antigen 10mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 20mcg	Experimental	Biological: SARS-CoV-2 beta variant RBD mRNA vaccineMIPSCo-mRNA-RBD-1 antigen 20mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1
SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 50mcg	Experimental	Biological: SARS-CoV-2 beta variant RBD mRNA vaccineMIPSCo-mRNA-RBD-1 antigen 50mcg administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1
Normal saline (0.9%)	Placebo comparator	Other: Normal SalineNormal saline (0.9%) administered intramuscularly as a 0.5 mL dose in a one dose regimen on Day 1

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

To be eligible for this study, participants must meet ALL of the following inclusion criteria:
Adults 18 to 64 years of age, inclusive at screening previously vaccinated with a 2-dose schedule of Cominarty™ or Vaxzevria™.
≥ 3 months (90 days) since receipt of a booster dose of either ComirnatyTM or SpikevaxTM.
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.
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:

Key exclusion criteria (28 listed)

Potential study participants will be excluded from the study if ANY of the following criteria apply:
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.
Participants with a BMI > 35kg/m2.
Positive result for rheumatoid factor (RF) at Screening.
Positive test at Screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen or hepatitis C virus antibody.

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
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.	Biological	Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 45mcg + MF59, Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1) 5mcg + MF59, Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1)15mcg + MF59
SARS-CoV-2 beta variant RBD mRNA vaccineSingle 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.	Biological	SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 10mcg, SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 20mcg, SARS-CoV-2 beta variant RBD mRNA vaccine (MIPSCo-mRNA-RBD-1) 50mcg
Normal SalinePlacebo comparator	Other	Normal saline (0.9%)

Primary outcome

Serious adverse events (SAEs), medically attended adverse events (MAAEs) and any adverse events (AEs) leading to study withdrawal at any time during the study.
Time frame: Through to study completion at Day 181.
Frequency
SAEs post vaccination.
Time frame: Day 1 to 29 (28 Days post vaccination).
Frequency
Solicited local and systemic reactogenicity AEs post vaccination.
Time frame: Within 7 days after vaccination (Day 1)
Frequency, severity, duration and peak intensity
Unsolicited AEs post vaccination.
Time frame: Day 1 to Day 29 (28 days post vaccination).
Frequency
Percentage of participants who achieve a boost response post vaccination.
Time frame: 28 days after vaccination
Defined as a 4-fold increase in SARS-CoV-2 neutralising or RBD-specific Ab titres from baseline.

5 secondary outcomes

MAAEs from Day 1 to 6 months after vaccination.
Time frame: 6 months after vaccination.
The number of participants that develop an antibody response at least 4 times higher than baseline antibody titers.
Time frame: At baseline (Day 1), Day 29 (28 days after vaccination), and 3, and 6 months after vaccination
Number of participants that mount a T cell response for SARS-CoV-2 RBD-derived peptide antigens.
Time frame: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
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).
Time frame: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.
The ratio of T cell derived type 1 versus type 2 cytokines in participants that mount a T cell response.
Time frame: Baseline (Day 1), Day 8 (7 days after vaccination), Day 29 (28 days after vaccination) and 3 and 6 months after vaccination.

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 15 May 2023.
Derived from this study: PubMed 38016322Nolan TM, Deliyannis G, Griffith M, Braat S, Allen LF, Audsley J, Chung AW, Ciula M, Gherardin NA, Giles ML, Gordon TP, Grimley SL, Horng L, Jackson DC, Juno JA, Kedzierska K, Kent SJ, Lewin SR, Littlejohn M, McQuilten HA, Mordant FL, Nguyen THO, Soo VP, Price B, Purcell DFJ, Ramanathan P, Redmond SJ, Rockman S, Ruan Z, Sasadeusz J, Simpson JA, Subbarao K, Fabb SA, Payne TJ, Takanashi A, Tan CW, Torresi J, Wang JJ, Wang LF, Al-Wassiti H, Wong CY, Zaloumis S, Pouton CW, Godfrey DI. Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster. EBioMedicine. 2023 Dec;98:104878. doi: 10.1016/j.ebiom.2023.104878. Epub 2023 Nov 27.
Individual participant dataSharing planned: No

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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.

Prof. Terry Nolan principal investigator

Peter Doherty Institute for Infection and Immunity, The University of Melbourne

2 sites 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 9 inclusion and 28 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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Serious adverse events (SAEs), medically attended adverse events (MAAEs) and any adverse events (AEs) leading to study withdrawal at any time during the study. (time frame: Through to study completion at Day 181.). 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 NCT05272605, 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 15 May 2023.