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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2022-12-21

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single Low Dose AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Single Medium Dose AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Single High Dose AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Two Low Doses AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Two Medium Doses AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Two High Doses AdCOVID

Group Type EXPERIMENTAL

AdCOVID

Intervention Type BIOLOGICAL

Administered intranasally

Single Dose Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered intranasally

Two Dose Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered intranasally

Interventions

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AdCOVID

Administered intranasally

Intervention Type BIOLOGICAL

Placebo

Administered intranasally

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes