COVID-19 Pandemic Clinical Trial
Official title:
Human Pilot Test of an Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine
Verified date | June 2022 |
Source | DreamTec Research Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis spore extract which contain Spike protein of the SARS-COV2 on the spore coat.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 85 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Macau | Macao Greater Bay Area Association of Healthcare Providers | Macau |
Lead Sponsor | Collaborator |
---|---|
DreamTec Research Limited | DreamTec Cytokine Limited |
Macau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the safety of the engineered Bacillus subtilis spore coat extract | To measure the weight changes in kilograms and number of incidence of adverse event from the beginning of the administration to 30 days after the administration | 3 months | |
Primary | Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2 | To measure the concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2 before the administration and 14, 28 days after the administration | 3 months |
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