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Trial registered on ANZCTR

Registration number

ACTRN12620000817943

Ethics application status

Approved

Date submitted

3/08/2020

Date registered

14/08/2020

Date last updated

8/09/2020

Date data sharing statement initially provided

14/08/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

A Phase 1/2 randomized, placebo-controlled, multi-centre study to evaluate the safety and immunogenicity of COVID-19 Vaccine in Healthy Adults

Scientific title

A randomized, observer-blind, placebo-controlled, Phase I/II study to evaluate the safety, reactogenicity and immunogenicity of Receptor Binding Domain (RBD) SARS-CoV-2 (COVID-19) Hepatitis B surface antigen (HBsAg) virus like particle (VLP) Vaccine in Healthy Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

SARS-CoV-2

COVID-19

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

RBD SARS-CoV-2 HBsAg VLP Vaccine, administered at two dose amounts, 5mcg and 25 mcg, by intramuscular injection by Investigators (or delegate) during in-clinic visit. Phase 1 will include three cohorts, to receive either 5mcg dose on Day 0 and 28; 25mcg dose on Days 0 and 28 or placebo on Day 0 and 28.

Phase 2 will evaluate both dose amounts either as single dose (given at day 0, with placebo at Day 28) or two doses (at Days 0 and 28). Participants will be randomised into one of 5 cohorts. These are 1) 5mcg dose administered on Days 0 and 28; 2) 25mcg dose administered on Days 0 and 28; 3) 5mcg dose administered on Days 0 and placebo on Day 28; 4) 25mcg dose administered on Days 0 and placebo on Day 28, or 5) placebo on day 0 and 28.

Phase 2 will commence following DSMB review of safety data from Phase 1.

Two groups of participants will be enrolled. Phase 1 will include a group of healthy adults aged 18-45. Phase 2 will include a separate group of healthy adults aged 18 - 79 years.

Participants will return to site at day 7 and 14 from vaccine administration dates to undergo safety assessments and blood sampling for immunogenicity evaluation. Further on site assessments are conducted monthly or bi-monthly for up to 180 days from date of first vaccine administration.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Phase I and II: Placebo vaccine containing aluminium hydroxide suspension, administered as two doses (0.25mL per dose) on days 0 and 28

Control group

Placebo

Outcomes

Primary outcome [1]

Phase II; To assess the composite endpoints of safety and reactogenicity of a the single and two-dose schedule of RBD SARS-CoV-2 HBsAg VLP vaccine administration as compared with placebo in healthy adults aged 18 - 79 years as determined through participant reported and clinically identified local and systemic adverse events. This will include safety blood assessment and the recording of solicited and unsolicited local and systemic adverse events by participants via an electronic diary or by the clinical staff as part of scheduled clinic visits

Timepoint [1]

Participant reported events reported daily for 7 days post-vaccination and then on occurrence up to 180 days post-vaccination

Primary outcome [2]

Phase I: To assess the composite endpoints of vaccine safety and reactogenicity of a two-dose schedule of two dose amounts of RBD SARS-CoV-2 HBsAg VLP vaccine as compared with two-dose administration of placebo in healthy adults aged 18 - 45 years as determined through participant reported (solicited and unsolicited) and clinically identified local and systemic adverse events (e.g. blood tests, vital signs, physical examination).

Timepoint [2]

Participant reported events reported daily for 7 days post-vaccination and then on occurrence up to 180 days post-vaccination

Primary outcome [3]

Phase II; To assess the immune response of a two-dose schedule of two dose amounts of RBD SARS-CoV-2 HBsAg VLP vaccine as compared with two-dose administration of placebo in healthy adults aged 18 - 79 years as determined through changes in participant immunity 56 days from first dose. To assess the immune response following a single-dose schedule of RBD SARS-CoV-2 HBsAg VLP vaccine as compared with placebo in healthy adults aged 18 - 79 years as determined through changes in participant immune response 56 days after receiving the vaccine dose. Immune response will be measured through analysis of blood samples.

Timepoint [3]

Increase in neutralising antibody titres as measured through to day 56

Secondary outcome [1]

Phase I; To assess the immune response of a two-dose schedule of RBD SARS-CoV-2 HBsAg VLP vaccine as compared with two-dose administration of placebo in healthy adults aged 18 - 45 years as determined through changes in participant serum blood immune response 28 days after receiving the second vaccine dose and through assessment of cellular immune response as taken from PBMC samples.

Timepoint [1]

Increase in neutralising antibody titres as measured at Day 14, 28, and 56 from date of first vaccine administration.

Eligibility

Key inclusion criteria

1. Male or Female aged 18 to 79 years (both inclusive)
a. Phase I: Subjects aged 18 to 45 years (both inclusive)
b. Phase II: Subjects aged 18 to 79 years (both inclusive)
2. Healthy participants as determined by medical history, physical examination, vital signs and clinical laboratory examination with no clinically significant deviations as judged by the Investigator at screening and randomization (Day 0)
3. Test negative for SARS-CoV-2 infection by RT-PCR test at screening
4. Test negative for SARS-CoV-2 IgG antibody by at screening
5. Capable and willing to provide written informed consent prior to the performance of any study-specific procedures

Minimum age

18 Years

Maximum age

79 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past
2. Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0)
3. Participants with a BMI > 35 kg/m2.
4. Presence of current active viral or bacterial infection, at screening and randomization (Day 0), which is determined by the Investigator to be of clinical significance
5. Individuals with history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, blood dyscrasia, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, asthma (with the exception of history of resolved childhood asthma), immunological and autoimmune diseases or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives
6. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID-19 hotspots/outbreak areas)
7. Pregnant or lactating women or willingness/intention to become pregnant during the study
8. Men and Women (of child-bearing potential) not agreeing to use adequate contraception during the study
9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection
10. Severely immunocompromised subjects. This exclusion category comprises a) subjects with solid organ transplantation; b) subjects with bone marrow transplantation; c) subjects under chemotherapy/radiotherapy; d) subjects with primary immunodeficiency; e) treatment with any anticytokine therapies. f) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks
11. History of solid or non-solid malignancy or lymphoma (except basal cell carcinoma of the skin and cervical carcinoma in situ)
12. Known allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema.
13. A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure.
14. Known hypersensitivity reactions to yeast.
15. Positive test result at screening for human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody.
16. Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator
17. History of demyelinating disease or Guillain Barre syndrome
18. Eczema or other significant skin lesion or infection at the site of vaccination
19. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
20. Positive screen for drugs of abuse#or alcohol (breath test) at screening and randomization (Day 0).
21. Participants who currently smoke 10 cigarettes or equivalent per day
22. Subjects not willing to/unable to comply with study procedures
23. Participating in any other study and have received any other investigational medication or device within 30 days prior to randomization or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
24. Receipt of blood/blood products/immunoglobulins or donation of blood/ blood products 8 weeks prior to vaccination or planned receipt or donation during the study period
25. Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Other design features

Phase

Phase 1 / Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

17/08/2020

Actual

22/08/2020

Date of last participant enrolment

Anticipated

30/11/2020

Actual

Date of last data collection

Anticipated

30/03/2021

Actual

Sample size

Target

280

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Nucleus Network - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Serum Institute of India Pvt Ltd

Address [1]

212/2, Off Soli Poonawalla Road, Hadapsar Pune - 411028

Country [1]

India

Primary sponsor type

Commercial sector/Industry

Name

Accelagen Pty Ltd

Address

Suite 1.02, 722 High Street
Kew East VIC 3102

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Serum Institute of India Pvt Ltd

Address [1]

212/2, Off Soli Poonawalla Road, Hadapsar Pune - 411028

Country [1]

India

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/07/2020

Approval date [1]

19/08/2020

Ethics approval number [1]

Summary

Brief summary

The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). 

The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies.

The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity reported after two-doses of vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity reported after receiving a single dose or two-doses of vaccine 28 days apart when compared with placebo.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Paul Griffin

Address

Nucleus Network 89 Commercial Road Melbourne, Victoria, 3004 Australia

Country

Australia

Phone

+61385939801

Fax

[email protected]

Contact person for public queries

Name

Greg Plunkett

Address

Accelagen Pty Ltd Suite 1.02, 722 High Street Kew East VIC 3102

Country

Australia

Phone

+61410552020

Fax

[email protected]

Contact person for scientific queries

Name

Greg Plunkett

Address

Accelagen Pty Ltd Suite 1.02, 722 High Street Kew East VIC 3102

Country

Australia

Phone

+61410552020

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Data from overall study population will be available within the clinical study report provided to participating sites, and scientific publications as prepared by Sponsor representatives or Study Investigators.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Coronavirus vaccine development: from SARS and MERS to COVID-19	2020	https://doi.org/10.1186/s12929-020-00695-2
Dimensions AI	COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies	2020	https://doi.org/10.1016/j.ejphar.2020.173751
Dimensions AI	COVID-19 vaccines – are we there yet?	2020	https://doi.org/10.18773/austprescr.2020.084
Embase	A Review on SARS-CoV-2-Induced Neuroinflammation, Neurodevelopmental Complications, and Recent Updates on the Vaccine Development.	2021	https://dx.doi.org/10.1007/s12035-021-02399-6
Embase	COVID-19 vaccines: The status and perspectives in delivery points of view.	2021	https://dx.doi.org/10.1016/j.addr.2020.12.011
Embase	Pharmaceutical Aspects and Clinical Evaluation of COVID-19 Vaccines.	2021	https://dx.doi.org/10.1080/08820139.2021.1904977
Embase	Review on up-to-date status of candidate vaccines for COVID-19 disease.	2021	https://dx.doi.org/10.2147/IDR.S288877
Embase	SARS-CoV-2: Targeted managements and vaccine development.	2021	https://dx.doi.org/10.1016/j.cytogfr.2020.11.001
Embase	Scientific rationale for developing potent RBD-based vaccines targeting COVID-19.	2021	https://dx.doi.org/10.1038/s41541-021-00393-6
Dimensions AI	A comprehensive overview of vaccines developed for pandemic viral pathogens over the past two decades including those in clinical trials for the current novel SARS-CoV-2	2021	https://doi.org/10.1039/d0ra09668g
Dimensions AI	A current novel perspective approach for coronavirus disease-2019 pandemic outbreak	2021	https://doi.org/10.4103/japtr.japtr_159_21
Dimensions AI	COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials	2021	https://doi.org/10.3390/ph14050406
Dimensions AI	COVID-19 vaccines: rapid development, implications, challenges and future prospects	2021	https://doi.org/10.1007/s13577-021-00512-4
Dimensions AI	SARS-CoV-2 vaccine development and how Brazil is contributing	2021	https://doi.org/10.1590/1678-4685-gmb-2020-0320
Dimensions AI	SARS-CoV-2 virus: Vaccines in development	2021	https://doi.org/10.1016/j.fmre.2021.01.009
Dimensions AI	Virus-like particles against infectious disease and cancer: guidance for the nano-architect	2021	https://doi.org/10.1016/j.copbio.2021.09.012
Embase	Analysis of the Protective Efficacy of Approved COVID-19 Vaccines Against Various Mutants.	2022	https://dx.doi.org/10.3389/fimmu.2022.804945
Embase	Success of nano-vaccines against COVID-19: a transformation in nanomedicine.	2022	https://dx.doi.org/10.1080/14760584.2022.2148659
Dimensions AI	A Review of Virus-Like Particle-Based SARS-CoV-2 Vaccines in Clinical Trial Phases	2022	https://doi.org/10.5812/ijpr-127042
Dimensions AI	Intranasal administration of BReC-CoV-2 COVID-19 vaccine protects K18-hACE2 mice against lethal SARS-CoV-2 challenge	2022	https://doi.org/10.1038/s41541-022-00451-7
Dimensions AI	Mechanisms of cellular and humoral immunity through the lens of VLP-based vaccines	2022	https://doi.org/10.1080/14760584.2022.2029415
Dimensions AI	Nanotechnology-facilitated vaccine development during the coronavirus disease 2019 (COVID-19) pandemic	2022	https://doi.org/10.1002/exp.20210082
Embase	Aspects of Nanotechnology for COVID-19 Vaccine Development and Its Delivery Applications.	2023	https://dx.doi.org/10.3390/pharmaceutics15020451
Embase	Nanovaccines to combat virus-related diseases.	2023	https://dx.doi.org/10.1002/wnan.1857
Embase	Protein-based nanocages for vaccine development.	2023	https://dx.doi.org/10.1016/j.jconrel.2022.12.022
Dimensions AI	A perspective on SARS-CoV-2 virus-like particles vaccines	2023	https://doi.org/10.1016/j.intimp.2022.109650
Dimensions AI	Advances in SARS-CoV-2 receptor-binding domain-based COVID-19 vaccines	2023	https://doi.org/10.1080/14760584.2023.2211153
Dimensions AI	Large-Scale Purification and Characterization of Recombinant Receptor-Binding Domain (RBD) of SARS-CoV-2 Spike Protein Expressed in Yeast	2023	https://doi.org/10.3390/vaccines11101602
Dimensions AI	Protein-based nano-vaccines against SARS-CoV-2: Current design strategies and advances of candidate vaccines	2023	https://doi.org/10.1016/j.ijbiomac.2023.123979

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically