ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620000674932

Ethics application status

Approved

Date submitted

5/06/2020

Date registered

12/06/2020

Date last updated

3/10/2024

Date data sharing statement initially provided

12/06/2020

Date results provided

3/10/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

An interventional study to evaluate the safety and immune response of a vaccine against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19 infection) when given to healthy adult participants.

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 (COVID-19 vaccine) In Healthy Adults Aged 18 To 55 Years Old And Healthy Older Adults, Aged 56 Years And Over

Secondary ID [1]

UQ-1-SARS-CoV-2-Sclamp

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

COVID-19

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will be conducted in two parts: Part 1 and Part 2.

Part 1 of the study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of SARS-CoV-2 Sclamp vaccine in healthy adult participants of age more than or equal to 18 years to less than or equal to 55 years. Part 2 of the study will evaluate multiple ascending doses (MAD) of SARS-CoV-2 Sclamp vaccine administered as an intramuscular injection in older healthy adult participants of age 56 years and above.

Participants in both Parts 1 and 2 will be randomized to receive Treatment A, B, C and D or placebo in the respective Cohorts.
• Treatment A: SARS-CoV-2 Sclamp vaccine 5 micrograms (mcg) in 0.5 milliliter (mL) suspension, as an intramuscular injection, administered as two separate doses at least 28 days apart on Day 1 and 29
• Treatment B: SARS-CoV-2 Sclamp vaccine 15 mcg in 0.5 mL suspension, as an intramuscular injection, administered as two separate doses at least 28 days apart on Day 1 and 29
• Treatment C: SARS-CoV-2 Sclamp vaccine 45 mcg in 0.5 mL suspension, as an intramuscular injection, administered as two separate doses at least 28 days apart on Day 1 and 29
• Treatment D: SARS-CoV-2 Sclamp vaccine 45 mcg in 0.5 mL suspension, as an intramuscular injection, administered as the first dose on Day 1, followed by placebo as the second dose at least 28 days apart on Day 29

Part 1 and Part 2 will include 3 Cohorts each.
• Part 1, Cohort 1- Treatment A (24 participants) or placebo (8 participants)
• Part 1, Cohort 2- Treatment B (24 participants) or placebo (8 participants)
• Part 1, Cohort 3- Treatment C (24 participants) and Treatment D (24 participants) or placebo (8 participants)
• Part 2, Cohort 1- Treatment A (24 participants) or placebo (8 participants)
• Part 2, Cohort 2- Treatment B (24 participants) or placebo (8 participants)
• Part 2, Cohort 3- Treatment C (24 participants) or placebo (8 participants)

A total of 216 subjects are planned to be included in the study. The anticipated study duration for any individual participant is up to approximately 14 months.

Intervention code [1]

Prevention

Comparator / control treatment

Placebo: 0.5 mL solution (sterile Saline for injection)

Control group

Placebo

Outcomes

Primary outcome [1]

To assess the safety and tolerability of SARS-CoV-2 Sclamp vaccine compared to placebo by evaluating:
- the frequency, duration and intensity of solicited local adverse events (AEs), including pain, redness, induration
- the frequency, duration and intensity of solicited systemic AEs, including fever, nausea, chills, diarrhoea, headache, fatigue, myalgia
- the frequency, duration, intensity, and relatedness of unsolicited AEs through to Day 57.
Solicited AEs will be assessed by severity score, frequency, duration and intensity by FDA toxicity scoring.

Timepoint [1]

Information on solicited AEs (local and systemic) will be collected for the 7 days following each vaccination (at Days 1 and 29)
Information on unsolicited AEs, SAEs and MAAEs will be collected from the time of consent through to study completion, Study completion is anticipated to be 12 months after the first dose of vaccine.
Information on any AEs leading to withdrawal will be collected from time of consent to the time of withdrawal/ study completion. Study completion is anticipated to be 12 months after the first dose of vaccine.
An interim analysis will be conducted after the first vaccination (Day 29), with the final analysis at the conclusion of the active study period (Day 57). Addenda to the study report will be produced for 6-month and 12-month follow-up data.

Primary outcome [2]

To assess the neutralizing antibody (NAb) immune responses elicited by SARS-CoV-2 Sclamp vaccine compared to placebo.
This will be evaluated by looking at the GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo by microneutralization (MN) assay

Timepoint [2]

Blood samples will be collected for analysis at Day 29 (28 days after first dose) and Day 57 (28 days after first dose).
A complete immunogenicity analysis will be performed at the conclusion of the active study period (Day 57).

Secondary outcome [1]

To compare the total serum antibody immune responses compared to placebo, to be done by looking at the GMT of the serum antibody response to the Sclamp antigen compared to placebo by antigen specific ELISA at Days 1, 15, 29 (28 days after the first dose) and Days 43, 57 (28 days after the second dose) and Days 209 and 394 (6 and 12 months post second dose respectively).

Timepoint [1]

Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination.
An interim analysis will be conducted after the first vaccination (Day 29) for serum antibody responses by ELISA, with the complete immunogenicity analysis at the conclusion of the active study period (Day 57).

Secondary outcome [2]

To compare the total serum antibody immune responses compared to placebo, to be done by determining the proportion of participants with greater than or equal to 4 fold increase in titre above baseline by ELISA. (serum antibody) at Days 15, 29, 43, 57, 209 and 394 post-vaccination compared to placebo.

Timepoint [2]

Secondary outcome [3]

To compare the NAb immune responses compared to placebo, to be done by determining the proportion of participants with greater than or equal to 4 fold increase in titre above baseline by MN assay (NAb) at Days 15, 29, 43, 57, 209 and 394 post-vaccination compared to placebo.

Timepoint [3]

Blood samples will be collected for analysis at baseline (Day 1) and at Days 15, 29, 43, 57, 209, and 394 post vaccination. A complete immunogenicity analysis will be performed at the conclusion of the active study period (Day 57).

Secondary outcome [4]

To compare the total NAb immune responses compared to placebo, to be done by looking at the GMT of the serum neutralizing antibody (NAb) titres to SARS-CoV-2 virus compared to placebo by MN assay at Days 1, 15, 29 (28 days after the first dose) and Days 43, 57 (28 days after the second dose) and Days 209 and 394 (6 and 12 months post second dose respectively).

Timepoint [4]

Eligibility

Key inclusion criteria

Part 1
1. Healthy male or non-pregnant female, greater than or equal to 18 and less than or equal to 55 years of age, with BMI greater than 18 and less than 34.0 kg/metres sqaured and body weight greater than or equal to 50.0 kg for males and greater than or equal to 45.0 kg for females.
2. Healthy as defined by:
a.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 is at the discretion of the Investigator, and the subject may have their scheduled dosing postponed until the condition resolves.
b.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 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 1 year.
4.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 least 28 days prior to 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 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 postmenopausal state. Examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include:
a. Simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment (active or placebo) administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
b. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner;
c. 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;
d. Sterile male partner (vasectomized since at least 6 months prior to first study treatment administration);
e. True abstinence, defined as no sexual intercourse (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.
5. WOCBP must have a negative urine pregnancy test (and negative serum pregnancy test in the event of a positive urine test) prior to receiving each dose.
6. 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.
7. Male subjects must be willing not to donate sperm until 90 days following the last study treatment administration.
8. 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.
9. Capable of, and have given, written consent.

Part 2
Subjects must meet all of the following criteria to be included in the study:
1. Healthy male or non-pregnant female equal to 56 years of age, with BMI >18 and <34.0 kg/m2 and body weight equal to 50.0 kg for males and equal to 45.0 kg for females.
2. Healthy as defined by:
a. 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.
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.
3. 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.
4. 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 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 post-menopausal state. Examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include:
a. 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;
b. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner;
c. 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;
d. Sterile male partner (vasectomized since at least 6 months prior to first study treatment administration);
e. 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.
5. WOCBP must have a negative urine pregnancy test prior to receiving each dose.
6. 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.
7. Male subjects must be willing not to donate sperm until 90 days following the last study treatment administration.
8. 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.
9. Capable of, and have given, written informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Part 1:
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 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.
2. Any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject’s participation.
3. 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.
4. Positive pregnancy, urine drug screen, or alcohol breath test at screening.
5. Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in the formulation (including the adjuvant, MF59C.1).
6. Presence of a known, or suspected, impairment of the immune system including, but not limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus.
7. 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.
8. History of significant alcohol abuse within 12 months year prior to screening.
9. 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.
10. 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.
11. 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:
a. Prescription medication within 14 days prior to the first dosing;
b. 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;
c. 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
d. Any other investigational coronavirus vaccine i.e. SARS--CoV-1, SARS--CoV-2, MERS etc. at any time prior to, or during, the study.
e. 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.
12. 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.
13. 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.
14. Breast-feeding subject, or subject who plans to breastfeed from the time of first dose through 60 days after last study treatment administration.
15. 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.
16. Employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or Syneos Health.
17. 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.
Part 2
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, 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.
2. Any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject’s participation.
3. 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.
4. Positive pregnancy, urine drug screen, or alcohol breath test at screening.
5. Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in the formulation (including the adjuvant, MF59C.1).
6. Presence of a known, or suspected, impairment of the immune system including, but not limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus.
7. 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.
8. History of significant alcohol abuse within 12 months prior to screening.
9. 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.
10. 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.
11. 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:
a. 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;
b. 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;
c. 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
d. Any other investigational coronavirus vaccine i.e. SARS-CoV-1, SARS-CoV-2, MERS etc. at any time prior to, or during, the study.
e. 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.
12. 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.
13. 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.
14. Breast-feeding subject, or subject who plans to breastfeed from the time of first dose through 60 days after last study treatment administration.
15. 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.
16. Employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or Syneos Health.
17. 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.
18. Permanent resident in an aged care facility (nursing or aged care home.

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)

Allocation involves contacting the holder of the allocation schedule who is the off-site pharmacist with no contact with participants.

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

Simple randomisation using a randomisation table created by computer software (i.e. computerised 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

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Safety

Statistical methods / analysis

It is planned to enroll approximately 216 male and female volunteers for participation in this study.
No prospective calculations of statistical power have been made, since no statistical hypothesis is associated with the objectives of the study. The sample size of 24 subjects per treatment group has been selected to provide information on safety and estimates related to the primary and secondary endpoints

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

14/07/2020

Actual

13/07/2020

Date of last participant enrolment

Anticipated

Actual

9/10/2020

Date of last data collection

Anticipated

Actual

10/10/2020

Sample size

Target

216

Accrual to date

Final

216

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston

Recruitment postcode(s) [1]

4007 - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Address [1]

School of Chemistry & Molecular Biosciences
Building 68, St Lucia QLD 4072

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

School of Chemistry & Molecular Biosciences
Building 68, St Lucia QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Coalition for Epidemic Preparedness Innovations (CEPI)

Address [1]

Marcus Thranes gate 2, 0473 Oslo

Country [1]

Norway

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Road, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2020

Approval date [1]

07/07/2020

Ethics approval number [1]

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

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paul Griffin

Address

Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD

Country

Australia

Phone

+61 402077302

Fax

p.griffin@nucleusnetwork.com.au

Contact person for public queries

Name

Paul Griffin

Address

Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD

Country

Australia

Phone

+61 402077302

Fax

p.griffin@nucleusnetwork.com.au

Contact person for scientific queries

Name

Paul Griffin

Address

Q-Pharm Pty. Ltd.,
Level 5, Clive Berghofer Cancer Research Centre (CBCRC),
300C Herston Road, Herston QLD

Country

Australia

Phone

+61 402077302

Fax

p.griffin@nucleusnetwork.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

individual participant data underlying published results only

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by sponsor, University of Queensland (UQ)
Contact rapid.response.trials@uq.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8021	Clinical study report			rapid.response.trials@uq.edu.au

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
Embase	Frontiers in the COVID-19 vaccines development.	2020	https://dx.doi.org/10.1186/s40164-020-00180-4
Embase	Immunological considerations for COVID-19 vaccine strategies.	2020	https://dx.doi.org/10.1038/s41577-020-00434-6
Embase	Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations.	2020	https://dx.doi.org/10.1080/14760584.2020.1825951
Embase	Prospect of SARS-CoV-2 spike protein: Potential role in vaccine and therapeutic development.	2020	https://dx.doi.org/10.1016/j.virusres.2020.198141
Embase	Vaccine Against Covid-19 Disease - Present Status of Development.	2020	https://dx.doi.org/10.1007/s12098-020-03475-w
Dimensions AI	Development of multi-epitope peptide-based vaccines against SARS-CoV-2	2020	https://doi.org/10.1016/j.bj.2020.09.005
Dimensions AI	Emerging Concepts and Technologies in Vaccine Development	2020	https://doi.org/10.3389/fimmu.2020.583077
Embase	A current novel perspective approach for coronavirus disease-2019 pandemic outbreak.	2021	https://dx.doi.org/10.4103/japtr.JAPTR_159_21
Embase	COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies.	2021	https://dx.doi.org/10.1016/j.ejphar.2020.173751
Embase	Deciphering Vaccines for COVID-19: where do we stand today?.	2021	https://dx.doi.org/10.1080/08923973.2020.1837867
Embase	Inside the story about the research and development of COVID-19 vaccines.	2021	https://dx.doi.org/10.7774/CEVR.2021.10.2.154
Embase	Mechanism involved in the pathogenesis and immune response against SARS-CoV-2 infection.	2021	https://dx.doi.org/10.1007/s13337-021-00687-2
Embase	Vaccine formulations in clinical development for the prevention of severe acute respiratory syndrome coronavirus 2 infection.	2021	https://dx.doi.org/10.1016/j.addr.2020.12.006
Dimensions AI	SARS-CoV-2 vaccine development and how Brazil is contributing	2021	https://doi.org/10.1590/1678-4685-gmb-2020-0320

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically