N/A
N=6
The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
COVID-19 Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT05057923 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Serum Neutralizing Receptor Binding Domain IgG Antibody Concentration — 0.2; 9.3; 35.8 ug/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bacillus subtilis (Biological)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- DreamTec Research Limited
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Neutralizing Receptor Binding Domain IgG Antibody Concentration |
0.2; 9.3; 35.8 | — |
| SECONDARY Lentirival Pseudovirus Neutralization Assay (Wild Type of SARS-CoV2) |
NA; NA; 76.33 | — |
| SECONDARY Lentirival Pseudovirus Neutralization Assay (D614G SARS-COV2 Variant) |
NA; NA; 82.4 | — |
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 spore coat.
Eligibility Criteria
Inclusion Criteria
- healthy
- age over 25 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 Sinovac over 4 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 30 days before the first dose
Data sourced from ClinicalTrials.gov (NCT05057923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.