25 and older, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Serum Neutralizing Receptor Binding Domain IgG Antibody ConcentrationPrimary· Day 0, 27, 42 post oral administration
Concentration of neutralizing IgG antibody against receptor binding domain of spike protein in SARS-COV2
Day 0
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
0.2
± 0.1
Day 27
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
9.3
± 5.4
Day 42
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
35.8
± 8.8
Lentirival Pseudovirus Neutralization Assay (Wild Type of SARS-CoV2)Secondary· Day 0, 27, 42 post oral administration
The ability of neutralization against SARS-CoV-2 was tested by an in vitro pseudo-virus neutralization assay. The lentivirus carrying a GFP gene was pseudotyped with the spike protein from a wild type of SARS-CoV-2. The pseudoviruses were then pre-incubated with serially diluted serum samples from orally vaccinated volunteers before being added to A549 lung carcinoma cells expressing human ACE2 and human TMPRSS2. The percentage of infection rate was measured with a fluorescent plate reader by counting GFP-positive cells. The results were fitted with a non-linear regression model. The dilution
EC50 of Day 27 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
NA
± NA
EC50 of Day 0 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
NA
± NA
EC50 of Day 42 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
76.33
± 38.7
Lentirival Pseudovirus Neutralization Assay (D614G SARS-COV2 Variant)Secondary· Day 0, 27, 42 post oral administration
The ability of neutralization against SARS-CoV-2 was tested by an in vitro pseudo-virus neutralization assay. The lentivirus carrying a GFP gene was pseudotyped with the spike protein from a D614G variant of SARS-CoV-2. The pseudoviruses were then pre-incubated with serially diluted serum samples from orally vaccinated volunteers before being added to A549 lung carcinoma cells expressing human ACE2 and human TMPRSS2. The percentage of infection rate was measured with a fluorescent plate reader by counting GFP-positive cells. The results were fitted with a non-linear regression model. The dilut
EC50 of Day 27 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
NA
± NA
EC50 of Day 0 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
NA
± NA
EC50 of Day 42 Serum diltuion in Pseudovirus inhibition assay
Group
Value
95% CI
Generation of Neutralizing Antibody for Unvaccinated Participants
82.4
± 29.2
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by DreamTec Research Limited
Last refreshed: 31 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05057923.