First human trial of a new COVID-19 vaccine SC-Ad6-1

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

This study is testing a new COVID-19 vaccine called SC-Ad6-1 in healthy volunteers to see how safe it is and how well it works when given in different ways.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Moat Biotechnology Corporation (Industry-sponsored)
• Locations: 1 site (Brisbane, Queensland)
• Trial ID: NCT04839042 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 clinical trial designed to evaluate the safety, reactogenicity, and immunogenicity of the investigational COVID-19 vaccine SC-Ad6-1 in healthy volunteers. The study will involve administering the vaccine through various routes including intramuscular, intranasal, and inhaled methods. Participants will receive either a single ascending dose or multiple doses of the vaccine, and the trial will monitor their responses to assess the vaccine's effects. The study is conducted at a single center in Brisbane, Queensland.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 60 who have been fully vaccinated against COVID-19.

Not a fit: Patients with significant underlying health conditions or chronic respiratory disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new option for COVID-19 prevention, potentially enhancing immunity against the virus.

How similar studies have performed: Other studies have shown success with similar vaccine approaches, but this specific vaccine is novel and represents a first-in-human evaluation.

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

Where this trial is running

Brisbane, Queensland

• Tetherex Study Site — Brisbane, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Russell Rother, Ph.D.

Conditions Covid19