Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)

Study Overview
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Brief Summary
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A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.

Official Title
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A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: AdCOVID
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 18 to 55 years, inclusive Good general health status Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator. For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test Willingness to practice a highly effective method of contraception Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period Exclusion Criteria: Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients Pregnant or lactating women or planning to conceive a child during the next 3 months Body mass index (BMI) > 30.0 kg/m2 Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19 An acute respiratory illness Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening Chronic or current cigarette smoking Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Low Dose AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Experimental: Single Medium Dose AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Experimental: Single High Dose AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Experimental: Two Low Doses AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Experimental: Two Medium Doses AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Experimental: Two High Doses AdCOVID<br> | Biological: AdCOVID<br>* Administered intranasally<br>|
| Placebo Comparator: Single Dose Placebo<br> | Other: Placebo<br>* Administered intranasally<br>|
| Placebo Comparator: Two Dose Placebo<br> | Other: Placebo<br>* Administered intranasally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity | Counts and percentages of subjects with local and systemic events | For 7 days after vaccination | 
| Adverse Events (AEs) | Counts and percentages of subjects with AEs | Day 1 to Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-SARS-CoV-2 spike IgG antibody levels |  | Day 1 to Day 366 | 
| Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus |  | Day 1 to Day 366 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Intranasal Vaccine