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
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
Accelagen Pty Ltd
3,468 participants
Jun 30, 2020
Interventional
Conditions
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.
Eligibility
Inclusion Criteria15
- Male or Female participants >/= 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
- 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
- Negative screening for SARS-CoV-2 infection (using a validated and approved PCR or serology test method) at time of consent
- Capable of giving informed consent
Exclusion Criteria21
- Known active Mycobacterium tuberculosis disease
- Fever (greater than or equal to 38 ºC) or any other respiratory symptoms/illnesses within the past 14 days
- BCG vaccination in the previous 12 months
- Has any BCG vaccine contraindication/s
- Confirmed existing or past COVID-19 infection by PCR or serology testing methods with or without symptoms
- Pregnant or breastfeeding women
- Women of child-bearing potential not agreeing to use adequate contraception
- Current active viral or bacterial infection
- Expected vaccination during the study period, independently of the type of vaccination
- 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
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Individuals known to be hypersensitive to any component of the vaccine
- Eczema or other significant skin lesion or infection at the site/s of injection.
- Any other medical condition which in the opinion of the investigator may affect the participant’s safety or study participation and conduct.
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Interventions
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
Locations(1)
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ACTRN12620000707965