None listed
Conditions
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.
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
Sponsors
Accelagen Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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.
Outcome results
None listed