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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
196
Tetherex Study Site
Brisbane, Queensland, Australia
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.
Time frame: 7 days following each dose
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
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