A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT04839042 |
Recruitment Status :
Recruiting
First Posted : April 9, 2021
Last Update Posted : August 22, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Biological: SC-Ad6-1 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 190 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | June 28, 2021 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: SC-Ad6-1 Low Dose Intramuscular
Low Dose SC-Ad6-1, I.M., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose |
Experimental: SC-Ad6-1 Medium Dose Intramuscular
Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose |
Experimental: SC-Ad6-1 High Dose #1 Intramuscular
High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose |
Experimental: SC-Ad6-1 High Dose #2 Intramuscular
High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., 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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., 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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose |
Experimental: SC-Ad6-1 Low Dose Intranasal
Low Dose SC-Ad6-1, I.N., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose |
Experimental: SC-Ad6-1 Medium Dose Intranasal
Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose |
Experimental: SC-Ad6-1 High Dose #1 Intranasal
High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose |
Experimental: SC-Ad6-1 High Dose #2 Intranasal
High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., 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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., 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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., 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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose |
Experimental: SC-Ad6-1 Low Dose Inhaled
Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
|
Biological: SC-Ad6-1
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)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose |
Experimental: SC-Ad6-1 High Dose Inhaled
High Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
|
Biological: SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-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.
- Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons [ Time Frame: 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 ]
- 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 ]
- 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 ]
- Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) [ Time Frame: 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 6 months prior to Day 1 (I.H. 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839042
Contact: Russell Rother, Ph.D. | 855-222-0722 | rrother@tetherex.com |
Australia, Queensland | |
Tetherex Study Site | Recruiting |
Brisbane, Queensland, Australia |
Study Director: | Russell Rother, Ph.D. | Moat Biotechnology Corporation |
Responsible Party: | Moat Biotechnology Corporation |
ClinicalTrials.gov Identifier: | NCT04839042 |
Other Study ID Numbers: |
SC-Ad6-1-002 |
First Posted: | April 9, 2021 Key Record Dates |
Last Update Posted: | August 22, 2023 |
Last Verified: | August 2023 |
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 |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Cloricromen Platelet Aggregation Inhibitors |