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A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers

Sponsor
Tetherex Pharmaceuticals Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04839042
Collaborator
(none)
130
Enrollment
1
Location
13
Arms
14.1
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: SC-Ad6-1
  • Biological: SC-Ad6-1
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 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 :
Jun 28, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose [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 [Up to 106 days following first dose]

  3. Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay [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) [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 [Up to 106 days following first dose]

  3. Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) [Up to 106 days following first dose]

  4. Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA)) [Up to 106 days following first dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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) and not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tetherex Study Site Brisbane Queensland Australia

Sponsors and Collaborators

  • Tetherex Pharmaceuticals Corporation

Investigators

  • Study Director: Russell Rother, Ph.D., Tetherex Pharmaceuticals Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tetherex Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT04839042
Other Study ID Numbers:
  • SC-Ad6-1-002
First Posted:
Apr 9, 2021
Last Update Posted:
May 5, 2022
Last Verified:
Apr 1, 2022
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:
COVID-19
Cloricromen

Study Results

No Results Posted as of May 5, 2022