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Trial - NCT05016934


Column Value
Trial registration number NCT05016934
Full text link
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05016934

First author
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

2021-08-23

Recruitment status
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - signed informed consent - previously totally immunized, i.e., two doses for corona vac (sinovac) or chadox1 (az 1222, astra zeneca, and one dose for ad26.co2.s (janssen) vaccines at least three months before enrollment - negative rt-pcr for sars-cov-2 at the moment of triage - no previous history of laboratory confirmed covid-19

Exclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

- pregnancy - participation in other vaccine trial - active decompensated chronic condition, namely, cardiovascular, respiratory, neurological, metabolic or hepatic diseases - any immunocompromise condition (primary immunodeficiencies, auto-immune diseases, long-term use of corticosteroids, solid organ transplant recipients, hematopoietic stem-cell transplant recipients, human-immunodeficiency virus active infection) - active cancer - hepatitis b or c - history of allergic reactions to any vaccine component, including excipients and preservatives (neomycin, streptomycin, polymyxin b, eggs - blood donation in the past 4 weeks before screening - received blood product in the past 3 months before screening

Number of arms
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Hospital do Coracao

Inclusion age min
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Frequency and severity of adverse events of special interest;Frequency and severity of local and systemic adverse events

Notes
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 23, 2021, 7 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Two applications of 10mcg of Versamune-CoV-2FC 28 days apart", "treatment_id": 1809, "treatment_name": "Versamune-cov-2fc", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two applications of 25mcg of Versamune-CoV-2FC 28 days apart", "treatment_id": 1809, "treatment_name": "Versamune-cov-2fc", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two applications of 50mcg of Versamune-CoV-2FC 28 days apart", "treatment_id": 1809, "treatment_name": "Versamune-cov-2fc", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]