Status:
COMPLETED
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
Lead Sponsor:
DreamTec Research Limited
Collaborating Sponsors:
Middle East Cell and Gene Therapy
National Institute of Genetic Engineering and Biotechnology
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis which express and display Spike protein of the SARS-COV2 on the spor...
Detailed Description
Bacillus subtilis is regarded as safe organism by The Food and Drug Administration and it is presented in most food sources. Preliminary experiments have shown that the genetically engineered Bacillus...
Eligibility Criteria
Inclusion
- healthy
- age over 12 years
- the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
- participant vaccinated with COVID-19 over 6 months
- anti-SARS CoV 2 neutralizing antibody is negative in serum.
Exclusion
- pregnant women
- history of COVID-19 infection or showing COVID-19 infection symptoms
- having had contact to people with known COVID-19 infection in the last 14 days
- having fever (\> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
- positive real time RT-PCR COVID-19 test.
- persons with autoimmune diseases
- allergic diathesis or any clinically significant allergic disease (i.e. asthma)
- any condition that might impair the immune response
- recent or current immunosuppressive medication
- any other vaccine application 5 months before the first dose
Key Trial Info
Start Date :
August 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05239923
Start Date
August 28 2021
End Date
December 30 2021
Last Update
February 15 2022
Active Locations (2)
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1
DreamTec Research Limited
Hong Kong, Hong Kong, 98125
2
Middle East Cell and Gene Therapy
Tehran, Iran