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| Column | Value |
|---|---|
| Trial registration number | NCT04685603 |
|
Full text link
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
mkaryana@gmail.com |
|
Registration date
Last imported at : Dec. 31, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-28 |
|
Recruitment status
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Unknown |
|
Study design
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Adaptive |
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Masking
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 18 years or older, in relatively good health with adequate physical and mental function including factors associated with in increased risk for medical complications associated with covid-19 infection or increased risk for exposure to sars-cov-2 |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
active covid-19 infection by pcr testing pre-existing igg or igm sars-cov-2 antibodies pregnant, known hypersensitivity to gm-csf known active immune deficiency disease or active hiv hbv, hcv, on active treatment with corticosteroids or other immunosuppressive agent participated in previous covid-19 vaccine study |
|
Number of arms
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
9 |
|
Funding
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Indonesia-MoH |
|
Inclusion age min
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Indonesia |
|
Type of patients
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
27 |
|
primary outcome
Last imported at : Dec. 31, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Frequency of any new-onset chronic medical conditions (NOCMCs);Frequency of any serious adverse events (SAEs);Frequency of medically attended adverse events (MAAEs);Frequency of solicited local and systemic reactogenicity adverse events (AEs);Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs);Safety Laboratory Values (Hematology);Safety Laboratory Values (Serum Chemistry) |
|
Notes
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Dec. 30, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "0.1 mg antigen, 0 mcg GMCSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 0 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 0 mcg GMCSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}] |