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Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores Expressing and Displaying the Receptor Binding Domain of Spike Protein of SARS-COV2

Expression of SARS-COV2 Spike Protein Receptor Binding Domain on Recombinant Bacillus subtilis on Spore Surface

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053747
Enrollment
Unknown
Registered
2021-11-28
Start date
2021-04-01
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

novel coronavirus pneumonia

Interventions

Case series:Bacillus subtilis spore

Sponsors

DreamTec Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. healthy; 2. age over 25 years; 3. 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); 4. participant vaccinated with Sinovac over 4 months; 5. anti-SARS CoV 2 neutralizing antibody is negative in serum.

Exclusion criteria

Exclusion criteria: 1. pregnant women; 2. history of COVID-19 infection or showing COVID-19 infection symptoms; 3. having had contact to people with known COVID-19 infection in the last 14 days; 4. 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; 5. positive real time RT-PCR COVID-19 test; 6. persons with autoimmune diseases; 7. allergic diathesis or any clinically significant allergic disease (i.e. asthma); 8. any condition that might impair the immune response; 9. recent or current immunosuppressive medication; 10. any other vaccine application 30 days before the first dose.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
Neutralizing antibody level;

Countries

China

Contacts

Public ContactKwong Wai Yeung

Dreamtec Limited

keithkwong@dreamtec.hk+852 95184614

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026