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Trial - NCT05239923


Column Value
Trial registration number NCT05239923
Full text link
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05239923

First author
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Keith Kwong

Contact
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

2022-02-15

Recruitment status
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

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

Number of arms
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

1

Funding
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

DreamTec Research Limited

Inclusion age min
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

12

Inclusion age max
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Hong Kong;Iran

Type of patients
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

35

primary outcome
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2;Safety of the engineered Bacillus subtilis

Notes
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1931, "treatment_name": "Bacillus subtilis", "treatment_type": "Bacterial antigen-spore expression vector", "pharmacological_treatment": "Vaccine"}]