A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
April 23, 2024 updated by: Moat Biotechnology Corporation
A Phase 1, First-In-Human, Open-label, Single Ascending Dose and Multidose Study to Assess the Safety, Reactogenicity, and Immunogenicity of the Adenovirus Vector SARS-CoV-2 Investigational Product SC-Ad6-1 Given Via Intramuscular, Intranasal or Inhaled Administration in Healthy Volunteers
This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
230
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Russell Rother, Ph.D.
- Phone Number: 855-222-0722
- Email: rrother@tetherex.com
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia
- Recruiting
- Tetherex Study Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Key Inclusion Criteria:
- Adult males and females, 18 to 60 years of age (inclusive)
- 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)
Key Exclusion Criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SC-Ad6-1 Low Dose Intramuscular
Low Dose SC-Ad6-1, I.M., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Medium Dose Intramuscular
Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #1 Intramuscular
High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #2 Intramuscular
High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Multiple Dose Intramuscular
Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #3 Intramuscular Booster
High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Low Dose Intranasal
Low Dose SC-Ad6-1, I.N., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Medium Dose Intranasal
Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #1 Intranasal
High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #2 Intranasal
High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Multiple Dose Intranasal
Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #3 Intranasal Booster
High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 High Dose #4 Intranasal Booster
High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Low Dose Inhaled
Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: SC-Ad6-1 Medium Dose Inhaled
Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
|
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: 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, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: 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, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
|
Experimental: 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, I.M., single or multiple-dose
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1, I.H., single or multiple-dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
|
|
Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
|
|
Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose
Time Frame: 7 days following each dose
|
Solicited local adverse events are defined as pain, redness and swelling at the site of dose administration for the intramuscular arms, are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms and are defined as stuffy nose, runny nose, dry mouth, mouth sores, sore or scratchy throat and cough for the inhalation arms.
Solicited systemic adverse events for all routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills.
|
7 days following each dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
|
Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
|
Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
|
Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))
Time Frame: Up to 106 days following first dose
|
Up to 106 days following first dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Russell Rother, Ph.D., Moat Biotechnology Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 7, 2021
First Posted (Actual)
April 9, 2021
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-Ad6-1-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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