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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05743335 |
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Full text link
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
banji.oduola@immornabio.com |
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Registration date
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
2023-02-24 |
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Recruitment status
Last imported at : March 18, 2023, 8 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 18, 2023, 8 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
main inclusion criteria sex: male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. age: 18 years of age or older, at screening. status: healthy subjects. subjects must have completed the full doses for primary vaccination with an approved sars-cov-2 vaccine and may have received booster dose(s), with the last vaccination (can be 2nd dose of primary vaccination or booster dose) having occurred at least 4 months prior to enrollment. main exclusion criteria current or prior symptomatic or asymptomatic sars-cov-2 infection confirmed by an approved or authorized rapid antigen test on day 1 or within 4 months prior to day 1. subjects with significant exposure (as defined by current cdc guidance) to someone with laboratory confirmed sars-cov-2 infection or covid-19 with the past 14 days prior to the screening visit. subjects with fever or signs of acute infection at the time of enrollment and vaccination. subjects who are taking medications that may prevent or treat covid-19. subjects who received convalescent serum or prior therapeutic antibodies against sars-cov-2 within 4 months before day 1. subjects with history of myocarditis or pericarditis, or with aes after mrna vaccination that are in nature and severity beyond the common aes expected and necessitating medical intervention. subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease. |
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Exclusion criteria
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Immorna Biotherapeutics, Inc. |
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Inclusion age min
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : March 18, 2023, 8 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
262 |
|
primary outcome
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
AE frequency;Injection site reaction;Medical AE frequency;SAE frequency;Solicited systemic reaction frequency;Unsolicited treatment-emergent AE frequency |
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Notes
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Phase 1", "treatment_id": 2692, "treatment_name": "Jcxh-221", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase 2", "treatment_id": 2692, "treatment_name": "Jcxh-221", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase 1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |