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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05542693 |
|
Full text link
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
2022-09-15 |
|
Recruitment status
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥ 18 years complete primary vaccination with cominarty (pfizer) or covishield (oxford/astrazeneca) vaccines, and at least one booster dose with cominarty (pfizer) or covishield (oxford/astrazeneca) vaccines. the last duration being at least 4 before the study duration. adult in a healthy condition or with a stable health status if pre-existing medical history. sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study for women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit and use an effective contraceptive method. |
|
Exclusion criteria
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
history of covid-19 in the 30 days before study enrollment. participation in other clinical studies in the last 12 (two) months. receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment. receive a blood or immunoglobulin transfusion within 90 days before study enrollment; blood donation up to 30 days before inclusion in the study; chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs. history of autoimmune disease or immunosuppression. rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site. body mass index (bmi) > 35. known or suspected drug or alcohol abuse in the last 6 months; history of previous anaphylaxis or severe allergic reactions to the vaccine, products known to contain polyethene glycol (peg) or unknown allergens. history of myocarditis or carditis. |
|
Number of arms
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Azidus Brasil |
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Inclusion age min
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
300 |
|
primary outcome
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination);Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority) |
|
Notes
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "5\u00b5g", "treatment_id": 562, "treatment_name": "Hdt 301 vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10\u00b5g", "treatment_id": 562, "treatment_name": "Hdt 301 vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |