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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

Tracking Information
First Submitted Date  ICMJE April 7, 2021
First Posted Date  ICMJE April 9, 2021
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2021)
  • 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.
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2021)
  • 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. Solicited systemic adverse events 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: SC-Ad6-1
    SC-Ad6-1, I.M., single or multiple-dose
  • Biological: SC-Ad6-1
    SC-Ad6-1, I.N., single or multiple-dose
Study Arms  ICMJE
  • Experimental: SC-Ad6-1 Low Dose Intramuscular
    Low Dose SC-Ad6-1, I.M., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 Medium Dose Intramuscular
    Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 High Dose Intramuscular
    High Dose SC-Ad6-1, I.M., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 Multiple Dose Intramuscular
    Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 Low Dose Intranasal
    Low Dose SC-Ad6-1, I.N., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 Medium Dose Intranasal
    Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 High Dose Intranasal
    High Dose SC-Ad6-1, I.N., single-dose (Day 1)
    Intervention: Biological: SC-Ad6-1
  • Experimental: SC-Ad6-1 Multiple Dose Intranasal
    Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22)
    Intervention: Biological: SC-Ad6-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2021)
80
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2021)
40
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jonathan Stocker, Ph.D. 855-222-0722 jstocker@tetherex.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04839042
Other Study ID Numbers  ICMJE SC-Ad6-1-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tetherex Pharmaceuticals Corporation
Study Sponsor  ICMJE Tetherex Pharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jonathan Stocker, Ph.D. Tetherex Pharmaceuticals Corporation
PRS Account Tetherex Pharmaceuticals Corporation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP