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

NCT04839042 | Completed Phase 1 FDA Drug

• 1 other identifier: SC-Ad6-1-002
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• 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

• Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons

  Up to 106 days following first dose

• Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay

  Up to 106 days following first dose

Secondary Outcomes (4)

• 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

• 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

• Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)

  Up to 106 days following first dose

• Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))

  Up to 106 days following first dose

Study Arms (18)

SC-Ad6-1 Low Dose Intramuscular

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Intramuscular

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #1 Intramuscular

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #2 Intramuscular

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Multiple Dose Intramuscular

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #3 Intramuscular Booster

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Low Dose Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #1 Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #2 Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Multiple Dose Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #3 Intranasal Booster

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #4 Intranasal Booster

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Low Dose Inhaled

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Inhaled

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Multiple High Dose Intranasal

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Multiple High Dose Inhaled

EXPERIMENTAL

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

Biological: SC-Ad6-1

SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled

EXPERIMENTAL

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

Biological: SC-Ad6-1

Interventions

SC-Ad6-1 BIOLOGICAL

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

SC-Ad6-1 High Dose #1 Intramuscular; SC-Ad6-1 High Dose #2 Intramuscular; SC-Ad6-1 High Dose #3 Intramuscular Booster; SC-Ad6-1 Low Dose Intramuscular; SC-Ad6-1 Medium Dose Intramuscular; SC-Ad6-1 Multiple Dose Intramuscular

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Moat Biotechnology Corporation: lead

Study Sites (1)

Tetherex Study Site

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Russell Rother, Ph.D.

  Moat Biotechnology Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: June 28, 2021
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)