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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679909
• Other study ID #: ALT-501-101
• Status: Completed
• Phase: Phase 1
• Start date: February 25, 2021
• Est. completion date: December 21, 2022

Study information

• Verified date: August 2023
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 21, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• AdCOVID
Administered intranasally

Other:
• Placebo
Administered intranasally

Locations

Country	Name	City	State
United States	Optimal Research	Austin	Texas
United States	AGA Clinical Trials	Hialeah	Florida
United States	Optimal Research	Melbourne	Florida
United States	Optimal Research	Peoria	Illinois
United States	Optimal Research	Rockville	Maryland
United States	Clinical Trials of Texas	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)		Day 1 to Day 366
Other	Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)		Day 1 to Day 366
Primary	Reactogenicity	Counts and percentages of subjects with local and systemic events	For 7 days after vaccination
Primary	Adverse Events (AEs)	Counts and percentages of subjects with AEs	Day 1 to Day 57
Secondary	Anti-SARS-CoV-2 spike IgG antibody levels		Day 1 to Day 366
Secondary	Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus		Day 1 to Day 366