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Trial registered on ANZCTR


Registration number
ACTRN12620000707965
Ethics application status
Approved
Date submitted
15/06/2020
Date registered
29/06/2020
Date last updated
8/09/2020
Date data sharing statement initially provided
29/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Placebo-Controlled Study to Evaluate the effect of the recombinant Bacillus Calmette–Guérin (BCG) vaccine VPM1002 on the Incidence or Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Participants in Australia
Scientific title
A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of the recombinant BCG VPM1002 on the Incidence or Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Participants in Australia
Secondary ID [1] 301609 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317863 0
Condition category
Condition code
Infection 315907 315907 0 0
Studies of infection and infectious agents
Infection 316024 316024 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VPM1002, a genetically modified BCG vaccine, is being developed with an aim to replace older generation BCG vaccines through demonstrating an improved safety profile and superior efficacy.

Participants will receive a single 0.1 mL intradermal injection by an investigator, research nurse or doctor that contains VPM1002, live, 2-8 x 10^5 CFU
Intervention code [1] 317822 0
Treatment: Drugs
Comparator / control treatment
Placebo: 0.1mL 0.9% sodium chloride

Participants will receive a single 0.1 mL intradermal injection by an investigator, research nurse or doctor
Control group
Placebo

Outcomes
Primary outcome [1] 324118 0
Evaluate the incidence SARS CoV-2/COVID-19 infection associated with acute respiratory symptoms between VPM1002 vaccinated participants compared with placebo as determined through the detection of COVID-19 infection in participants using validated laboratory methods within approved testing facilities. The types of test methods will be determined based on testing procedures in place
Timepoint [1] 324118 0
Participants will provide data relating to acute respiratory symptoms monthly for up to 6 months (180 days) post-vaccine administration
Primary outcome [2] 324230 0
Evaluate the incidence of laboratory confirmed SARS CoV-2/COVID-19 infection with severe, critical or life-threatening disease severity based on medical records for VPM1002 vaccinated participants compared with participants who receive placebo
Timepoint [2] 324230 0
Outcomes assessed for each occurrence for up to 6 months (180 days) post-vaccine administration
Secondary outcome [1] 383805 0
To evaluate the difference in the duration of participant reported acute respiratory symptoms using a study app for participants vaccinated with VPM1002 compared to participants receiving placebo
Timepoint [1] 383805 0
On occurrence during the 6 months (180 days) post-vaccine administration
Secondary outcome [2] 383806 0
To evaluate the difference in duration of participant reported acute respiratory symptoms consistent with SARS CoV-2/COVID-19 infection using a study app for VPM1002 vaccinated participants compared to placebo
Timepoint [2] 383806 0
On occurrence during the 6 months (180 days) post-vaccine administration
Secondary outcome [3] 383807 0
To evaluate the difference in severity of SARS-CoV-2/COVID-19 disease symptoms as reported using a study app for VPM1002 vaccinated participants compared to placebo
Timepoint [3] 383807 0
On occurrence during the 6 months (180 days) post-vaccine administration
Secondary outcome [4] 383808 0
To evaluate the difference in severity of SARS-CoV-2/COVID-19 disease symptoms as reported using a study app by participants with co-morbidities receiving VPM1002 vaccination compared to placebo
Timepoint [4] 383808 0
On occurrence of symptoms during the 6 months (180 days) post-vaccine administration
Secondary outcome [5] 383809 0
To evaluate the difference in severity of SARS-CoV-2/COVID-19 disease symptoms as reported using a study app by elderly participants aged 65 years and older receiving VPM1002 vaccination compared to participants receiving placebo
Timepoint [5] 383809 0
On occurrence of symptoms during the 6 months (180 days) post-vaccine administration
Secondary outcome [6] 383810 0
To assess the frequency and severity of adverse events following VPM1002 administration in participants such as injection site pain, redness, swelling or systemic events such as fever, headache using participant reported data using study app, body temperature readings and any hospital records as appropriate.
Timepoint [6] 383810 0
On occurrence of symptoms during the 6 months (180 days) post-vaccine administration

Eligibility
Key inclusion criteria
1. Male or Female participants >/= 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
2. Participants with high-risk of infection to COVID-19 cases defined as:
• Health care workers (physicians, nurses, paramedical staff) working in direct contact with COVID-19 patients
• Other high-risk participants who are aged >/= 65 years or aged >/= 18 years with co-morbidities such as:
• Insulin dependent or non-insulin dependent diabetes mellitus
• Hypertension
• Past history of completed acute myocardial infarction
• Cardiac failure of NYHA class 2 and above
• Rheumatic heart disease
• Chronic obstructive pulmonary disease, bronchiectasis or emphysema
• Chronic suppurative lung disease
• Cystic fibrosis
• Pulmonary fibrosis
3. Negative screening for SARS-CoV-2 infection (using a validated and approved PCR or serology test method) at time of consent
4. Capable of giving informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known active Mycobacterium tuberculosis disease
2. Fever (greater than or equal to 38 ºC) or any other respiratory symptoms/illnesses within the past 14 days
3. BCG vaccination in the previous 12 months
4. Has any BCG vaccine contraindication/s
5. Confirmed existing or past COVID-19 infection by PCR or serology testing methods with or without symptoms
6. Pregnant or breastfeeding women
7. Women of child-bearing potential not agreeing to use adequate contraception
8. Current active viral or bacterial infection
9. Expected vaccination during the study period, independently of the type of vaccination
10. Severely immunocompromised participants. This exclusion category comprises
a) participants with known infection by the HIV;
b) participants with solid organ transplantation;
c) participants with bone marrow transplantation;
d) participants under chemotherapy/radiotherapy;
e) participants with primary immunodeficiency;
f) treatment with any anticytokine therapies.
g) 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. Active solid or non-solid malignancy or lymphoma within the prior two years
12. Individuals known to be hypersensitive to any component of the vaccine
13. Eczema or other significant skin lesion or infection at the site/s of injection.
14. Any other medical condition which in the opinion of the investigator may affect the participant’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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The Sponsor has elected to cease the study prior to commencing recruitment for commercial reasons.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 305955 0
Commercial sector/Industry
Name [1] 305955 0
Serum Institute of India Pvt Ltd
Address [1] 305955 0
212/2, O Soli Poonawalla Road, Hadapsar
Pune - 411028
Country [1] 305955 0
India
Primary sponsor type
Commercial sector/Industry
Name
Accelagen Pty Ltd
Address
Suite 1.02, 722 High Street Kew East Victoria 3102
Country
Australia
Secondary sponsor category [1] 306503 0
Commercial sector/Industry
Name [1] 306503 0
Serum Institute of India Pvt Ltd
Address [1] 306503 0
212/2, O Soli Poonawalla Road, Hadapsar
Pune - 411028
Country [1] 306503 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306198 0
St Vincents Hospital Melbourne
Ethics committee address [1] 306198 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 306198 0
Australia
Date submitted for ethics approval [1] 306198 0
Approval date [1] 306198 0
29/05/2020
Ethics approval number [1] 306198 0

Summary
Brief summary
This is a multicentre, placebo controlled, randomized, double blind, adaptive study to evaluate the reduction in infection incidence and severity of SARS-CoV-2/ COVID-19 infection among high-risk participants by enhanced trained immune response through VPM1002 vaccine.

Participants who fulfil the criteria for high-risk of COVID-19 infection will be enrolled. The Investigator/site staff at each site will inform the healthcare workers (HCWs) about the clinical trial while other high-risk participants will be recruited through referral via COVID-19 clinics or within medical centres/aged care facilities.

Follow-up information must be entered by the participants regularly via a study specific mobile App using a phone/tablet/laptop. Participants will receive reminders to enter the data, including temperature reading to indicate the occurrence of fever.

During the follow-up, if any participant experiences fever AND cough and/or shortness of breath, all attempts should be made to obtain a throat (nasopharyngeal and/or oropharyngeal) swab or any appropriate sample as directed by the treating physician. Participants can consult/visit the study site anytime during the study for emergencies or any safety concerns.

Interim analyses are planned at 2-monthly intervals during the study to assess the efficacy and futility based on which the study will be stopped. An independent Data and Safety Monitoring Board (DSMB) will be appointed to review the safety and primary endpoint data for efficacy/futility. Safety data pertaining to incidences of SARS-CoV-2/COVID-19 infections, hospitalizations, ICU admissions and deaths and interim analysis data will be provided to the DSMB who will provide their observations to the sponsor with recommendations as to whether there are safety concerns and whether the study should continue without change, be modified, or terminated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103058 0
A/Prof Mark Bloch
Address 103058 0
Holdsworth House Medical Centre
Level 3/26 College St, Sydney NSW 2010
Country 103058 0
Australia
Phone 103058 0
+61 0293317228
Fax 103058 0
Email 103058 0
mark.bloch@holdsworthhouse.com.au
Contact person for public queries
Name 103059 0
Mr Greg Plunkett
Address 103059 0
Accelagen Pty Ltd
Suite 1.02, 722 High Street Kew East VIC 3102
Country 103059 0
Australia
Phone 103059 0
+61 0391142274
Fax 103059 0
Email 103059 0
VPM1002_covid19@accelagen.com.au
Contact person for scientific queries
Name 103060 0
Mr Greg Plunkett
Address 103060 0
Accelagen Pty Ltd
Suite 1.02, 722 High Street Kew East VIC 3102
Country 103060 0
Australia
Phone 103060 0
+61 0391142274
Fax 103060 0
Email 103060 0
VPM1002_covid19@accelagen.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from overall study population will be available within the clinical study report provided to
participating sites, and scienti c publications as prepared by Sponsor representatives or Study
Investigators.
What supporting documents are/will be available?
No other documents available
Summary results
No Results