Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects
Scientific Title of Study
A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects
Plot No 64, Vanagaram-Ambattur Rd, Ayanambakkam, Kil Ayanambakkam,
Chennai-600095, Tamil Nadu
Chennai
9840411858
jayasree.krishnan@yahoo.co.in
Dr Muralidhar Tambe
B. J. Medical College
Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001, Maharashtra, India Pune
9423007898
deanbjmcpune@gmail.com
Dr Bhaskar Deshmukh
Baramati Hospital
New Indapur Ring Road, behind K Moropant Sabhagruha, Near Central Building, Baramati-413102,Maharashtra. Pune
02112-220940
bhaskar.jedhe@gmail.com
Dr Suninder Singh Arora
Batra Hospital and Medical Research Centre
1 Tughlakabad Institutional Area, Mehrauli Badarpur Road New Delhi-110062 South
9810113414
drssarora@gmail.com
Dr Sanjay Lalwani
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Department of Pediatrics,
Pune-Satara Road, Katraj Dhankawadi,Pune-411043 Pune
9822051716
sanjaylalwani2007@rediffmail.com
Dr Nita Shanbhag
Dr D Y Patil Hospital
Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra Mumbai
9322402424
nita@eyesurgeon.in
Dr Kirti Sabnis
Fortis Hospitals Limited
101, Mulund Goregaon Link Road, Bhandup West, Mumbai, Maharashtra - 400078 India Mumbai
9626553112
drkirtisangeet@gmail.com
Dr Avinash Gawande
Government Medical College and Hospital
Medical College Square Road, Nagpur-440003, Maharashtra Nagpur
Coronavirus as the cause of diseases classified elsewhere
Patients
Encounter for immunization
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Placebo, 0.9% sodium chloride
Dose : 0.1 ml, single dose to be administered as an intradermal injection
Intervention
recombinant BCG vaccine, VPM1002
Dose : 0.1 ml, single dose of the reconstituted vaccine to be administered as an intradermal injection
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or Female subjects ≥ 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
2. Test negative for SARS-CoV-2 infection (RT-PCR test) at screening
3. Capable of giving informed consent
ExclusionCriteria
Details
1. Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection
2. Received BCG vaccine within one year prior to screening
3. Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days
4. Pregnant or lactating women
5. Women of child-bearing potential not agreeing to use adequate contraception
6. Current active viral or bacterial infection
7. Expected vaccination during the study period, independently of the type of vaccination
8. Severely immunocompromised subjects.
9. Active solid or non-solid malignancy or lymphoma within the prior two years
10. Individuals known to be hypersensitive to any component of the vaccine
11. Eczema or other significant skin lesion or infection at the site/s of injection.
12. Any other medical condition which in the opinion of the investigator may affect the subject’s safety or study participation and conduct
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs
2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects
3.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among HCWs
4.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among other high-risk subjects
up to 6 months (180 days) following vaccine administration
Secondary Outcome
Outcome
TimePoints
1.Duration of COVID-19 symptoms in HCWs
2.Duration of COVID-19 symptoms in other high-risk subjects
3.Severe Disease Outcomes in HCWs
4.Severe Disease Outcomes in other high-risk subjects
5.Severe Disease Outcomes among in elderly subjects (greater than or equal to 60 years)
6.Severe Disease Outcomes among subjects with Co-morbidities
7.Incidence of Adverse Events and Serious Adverse Events
up to 6 months (180 days) following vaccine administration
Target Sample Size
Total Sample Size="5946" Sample Size from India="5946"
This is a placebo controlled, multicentric, randomized, double blind, adaptive study to evaluate the reduction in infection incidence and severity of SARS-CoV-2/ COVID-19 infection among high-risk subjects by enhanced trained immune response through VPM1002 vaccine. Subjects who provide informed consent will be assessed for eligibility criteria. The subjects who fulfill all the eligibility criteria will be randomized in a 2:1 ratio to receive a single dose (0.1 ml) of either VPM1002 or placebo, administered as an intradermal injection. The duration of follow-up will be based on the results of interim analysis however the maximum follow-up period will be up to 180 days.
