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| Column | Value |
|---|---|
| Trial registration number | NCT04871737 |
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Full text link
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 9, 2022, 3 p.m. Source : ClinicalTrials.gov |
sponce@procliniq.com |
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Registration date
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
2021-05-04 |
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Recruitment status
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - adult men and women ≥18 year-old and ≤55-year-old. - signed informed consent. - no respiratory disease within last 21 days prior to first dose administration. - body mass index from 18.0 to 29.0 kg/m2. - negative rt-pcr for sars-cov-2 infection. - negative test for anti-sars-cov-2 igm and igg antibodies. - o2 saturation ≥92% by pulse oximetry. - normal ct scan of thorax. - no symptoms from clinical history and normal physical exam at screening visit. - lab test values within normal ranges for all the following: urinalysis. liver enzymes. renal function tests. cholesterol and triglycerides. fasting glucose. hematology. - negative test for hbsag, anti-hcv and anti-hiv antibodies. negative vdrl test. - normal electrocardiogram. - negative pregnancy test for women with childbearing potential. - agreement of all sexually- active volunteers to use highly effective contraceptives over the study period and up to 30 days after the last administration of the experimental vaccine. - commitment from all participants to keep social distancing, use of mask and frequent hand washing with soap or antibacterial gel during the study period. |
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Exclusion criteria
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
- history of hypersensitivity or allergy to any ingredient of the vaccine. - history of severe anaphylactic reaction. - history of seizures. - history of chronic diseases or cancer. - vaccination against sars-cov-2 with approved or experimental vaccines. - participation in any other study with an experimental intervention within the last 3 months. - administration of any other drug or herbal preparation within the last 30 days. - any vaccine administered within the last 30 days, including influenza vaccine. - fever at the time of entry. - blood transfusion or blood components transfusion within the last 4 months. - regular activity related to work, social interaction or entertainment that represents an exposure to sars-cov-2 higher than that of the general population, as per investigator judgement. - drug and alcohol abuse. - any medical or not medical condition that could interfere with patient safety, study compliance or data interpretation, as per investigator judgement. |
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Number of arms
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
10 |
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Funding
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Laboratorio Avi-Mex, S.A. de C.V. |
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Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
55 |
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Countries
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Mexico |
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Type of patients
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
91 |
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primary outcome
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: adverse events;Safety: Oxygen saturation;Safety: Pregnancy test;Safety: Pregnancy test;Safety: Urinalysis |
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Notes
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Dose: 10 7.0-7.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 7.5-7.99 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 8.0-8.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 7.0-7.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 7.5-7.99 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 8.0-8.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 7.0-7.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 7.5-7.99 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 8.0-8.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose: 10 8.0-8.49 EID 50/dose", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}] |