Clinical trial NCT04839042: A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Moat Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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


Eligibility 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
* 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

Primary outcomes:
measure: Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose
timeFrame: 7 days following each dose
measure: Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons
timeFrame: Up to 106 days following first dose
measure: Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay
timeFrame: Up to 106 days following first dose
Secondary outcomes:
measure: Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)
timeFrame: Up to 106 days following first dose
measure: Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA
timeFrame: Up to 106 days following first dose
measure: Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)
timeFrame: Up to 106 days following first dose
measure: Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))
timeFrame: Up to 106 days following first dose
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Tetherex Study Site
state: Queensland
Study officials:
affiliation: Moat Biotechnology Corporation
name: Russell Rother, Ph.D.
role: STUDY_DIRECTOR
References: