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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839042
• Other study ID #: SC-Ad6-1-002
• Status: Recruiting
• Phase: Phase 1
• Start date: June 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Moat Biotechnology Corporation
• Contact: Russell Rother, Ph.D.
• Phone: 855-222-0722
• Email: rrother[@]tetherex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), intranasal (IN) or inhaled (IH) route in healthy volunteers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose
• SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose
• SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose

Locations

Country	Name	City	State
Australia	Tetherex Study Site	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Moat Biotechnology Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with solicited local and systemic adverse events for 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
Primary	Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons		Up to 106 days following first dose
Primary	Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay		Up to 106 days following first dose
Secondary	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
Secondary	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
Secondary	Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)		Up to 106 days following first dose
Secondary	Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))		Up to 106 days following first dose