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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 : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Tetherex Pharmaceuticals Corporation

Brief Summary:
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) or intranasal (IN) route in healthy volunteers.

Condition or disease Intervention/treatment Phase
Covid19 Biological: SC-Ad6-1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 or Intranasal Administration in Healthy Volunteers
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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 Intramuscular
High 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 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 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 Intranasal
High 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 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




Primary Outcome Measures :
  1. 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 and are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms. Solicited systemic adverse events for both routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills.

  2. Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons [ Time Frame: Up to 106 days following first dose ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) [ Time Frame: Up to 106 days following first dose ]
  4. Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA)) [ Time Frame: Up to 106 days following first dose ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Jonathan Stocker, Ph.D. 855-222-0722 jstocker@tetherex.com

Locations
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Australia, Queensland
Tetherex Study Site Recruiting
Brisbane, Queensland, Australia
Sponsors and Collaborators
Tetherex Pharmaceuticals Corporation
Investigators
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Study Director: Jonathan Stocker, Ph.D. Tetherex Pharmaceuticals Corporation
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Responsible Party: Tetherex Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT04839042    
Other Study ID Numbers: SC-Ad6-1-002
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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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
Additional relevant MeSH terms:
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Cloricromen
Platelet Aggregation Inhibitors