A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
NCT ID: NCT04839042
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
196 participants
INTERVENTIONAL
2021-06-28
2025-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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SC-Ad6-1 Low Dose Intramuscular
Low Dose SC-Ad6-1, I.M., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 Medium Dose Intramuscular
Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 High Dose #1 Intramuscular
High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 High Dose #2 Intramuscular
High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 Multiple Dose Intramuscular
Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 High Dose #3 Intramuscular Booster
High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1)
SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1 Low Dose Intranasal
Low Dose SC-Ad6-1, I.N., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 Medium Dose Intranasal
Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 High Dose #1 Intranasal
High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 High Dose #2 Intranasal
High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 Multiple Dose Intranasal
Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 High Dose #3 Intranasal Booster
High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 High Dose #4 Intranasal Booster
High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 Low Dose Inhaled
Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
SC-Ad6-1 Medium Dose Inhaled
Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
SC-Ad6-1 Multiple High Dose Intranasal
Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1 Multiple High Dose Inhaled
Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29)
SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled
Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29)
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
Interventions
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SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening
* Must have been fully vaccinated against COVID-19 and received last dose not less than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only), not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) and not less than 12 months prior to Day 1 (I.H. booster arms and I.N or I.H. multiple dose booster arms only)
Exclusion Criteria
* History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to Screening) or ongoing respiratory tract infection
* History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members
* History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
* Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test (non-booster arms only)
* Any history of malignant disease ≤5 years prior to registration
* History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
18 Years
60 Years
ALL
Yes
Sponsors
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Moat Biotechnology Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Russell Rother, Ph.D.
Role: STUDY_DIRECTOR
Moat Biotechnology Corporation
Locations
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Tetherex Study Site
Brisbane, Queensland, Australia
Countries
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Other Identifiers
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SC-Ad6-1-002
Identifier Type: -
Identifier Source: org_study_id
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