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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04839042




Registration number
NCT04839042
Ethics application status
Date submitted
7/04/2021
Date registered
9/04/2021
Date last updated
25/04/2024

Titles & IDs
Public title
A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
SC-Ad6-1-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SC-Ad6-1
Other interventions - SC-Ad6-1
Other interventions - SC-Ad6-1

Experimental: SC-Ad6-1 Low Dose Intramuscular - Low Dose SC-Ad6-1, I.M., single-dose (Day 1)

Experimental: SC-Ad6-1 Medium Dose Intramuscular - Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)

Experimental: SC-Ad6-1 High Dose #1 Intramuscular - High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1)

Experimental: SC-Ad6-1 High Dose #2 Intramuscular - High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1)

Experimental: SC-Ad6-1 Multiple Dose Intramuscular - Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22)

Experimental: SC-Ad6-1 High Dose #3 Intramuscular Booster - High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1)

Experimental: SC-Ad6-1 Low Dose Intranasal - Low Dose SC-Ad6-1, I.N., single-dose (Day 1)

Experimental: SC-Ad6-1 Medium Dose Intranasal - Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)

Experimental: SC-Ad6-1 High Dose #1 Intranasal - High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1)

Experimental: SC-Ad6-1 High Dose #2 Intranasal - High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1)

Experimental: SC-Ad6-1 Multiple Dose Intranasal - Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22)

Experimental: SC-Ad6-1 High Dose #3 Intranasal Booster - High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1)

Experimental: SC-Ad6-1 High Dose #4 Intranasal Booster - High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1)

Experimental: SC-Ad6-1 Low Dose Inhaled - Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1)

Experimental: SC-Ad6-1 Medium Dose Inhaled - Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1)

Experimental: SC-Ad6-1 Multiple High Dose Intranasal - Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29)

Experimental: SC-Ad6-1 Multiple High Dose Inhaled - Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29)

Experimental: SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled - Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29)


Other interventions: SC-Ad6-1
SC-Ad6-1, I.M., single or multiple-dose

Other interventions: SC-Ad6-1
SC-Ad6-1, I.N., single or multiple-dose

Other interventions: SC-Ad6-1
SC-Ad6-1, I.H., single or multiple-dose
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose
Timepoint [1] 0 0
7 days following each dose
Primary outcome [2] 0 0
Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons
Timepoint [2] 0 0
Up to 106 days following first dose
Primary outcome [3] 0 0
Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay
Timepoint [3] 0 0
Up to 106 days following first dose
Secondary outcome [1] 0 0
Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)
Timepoint [1] 0 0
Up to 106 days following first dose
Secondary outcome [2] 0 0
Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA
Timepoint [2] 0 0
Up to 106 days following first dose
Secondary outcome [3] 0 0
Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)
Timepoint [3] 0 0
Up to 106 days following first dose
Secondary outcome [4] 0 0
Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))
Timepoint [4] 0 0
Up to 106 days following first dose

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Tetherex Study Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Moat Biotechnology Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04839042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Russell Rother, Ph.D.
Address 0 0
Moat Biotechnology Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Russell Rother, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
855-222-0722
Fax 0 0
Email 0 0
rrother@tetherex.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04839042