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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: AdCOVID; Other: Placebo

• Registration Number: NCT04679909
• Lead Sponsor: Altimmune, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-22
• Study Start: 2021-02-25
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Low Dose AdCOVID	AdCOVID	-
Two Medium Doses AdCOVID	AdCOVID	-
Two High Doses AdCOVID	AdCOVID	-
Single High Dose AdCOVID	AdCOVID	-
Two Dose Placebo	Placebo	-
Two Low Doses AdCOVID	AdCOVID	-
Single Medium Dose AdCOVID	AdCOVID	-
Single Dose Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Day 1 to Day 57	Counts and percentages of subjects with AEs
Reactogenicity	For 7 days after vaccination	Counts and percentages of subjects with local and systemic events

Secondary Outcome Measures

Name	Time	Method
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus	Day 1 to Day 366
Anti-SARS-CoV-2 spike IgG antibody levels	Day 1 to Day 366

Trial Locations

Locations (3)

AGA Clinical Trials; 🇺🇸 Hialeah, Florida, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States

Optimal Research; 🇺🇸 Austin, Texas, United States