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

Moat Biotechnology

Status and phase

Enrolling

Phase 1

Conditions

Covid19

Treatments

Biological: SC-Ad6-1

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04839042

SC-Ad6-1-002

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

230 participants in 18 patient groups

SC-Ad6-1 Low Dose Intramuscular

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Intramuscular

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #1 Intramuscular

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #2 Intramuscular

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Multiple Dose Intramuscular

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #3 Intramuscular Booster

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Low Dose Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #1 Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #2 Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Multiple Dose Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #3 Intranasal Booster

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 High Dose #4 Intranasal Booster

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Low Dose Inhaled

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Medium Dose Inhaled

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Multiple High Dose Intranasal

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

SC-Ad6-1 Multiple High Dose Inhaled

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

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

Experimental group

Description:

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

Treatment:

Biological: SC-Ad6-1

Trial contacts and locations

Central trial contact

Russell Rother, Ph.D.

Data sourced from clinicaltrials.gov

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