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OpenTrials
Completed

NCT Number: NCT04679909

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AGA Clinical Trials, Hialeah, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AdCOVID

Biological

Administered intranasally

Placebo

Other

Administered intranasally

Primary outcomes

  1. Reactogenicity

    Time frame: For 7 days after vaccination

    Counts and percentages of subjects with local and systemic events

  2. Adverse Events (AEs)

    Time frame: Day 1 to Day 57

    Counts and percentages of subjects with AEs

Secondary outcomes

  1. Anti-SARS-CoV-2 spike IgG antibody levels

    Time frame: Day 1 to Day 366

  2. Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus

    Time frame: Day 1 to Day 366

Other outcomes

  1. Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)

    Time frame: Day 1 to Day 366

  2. Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)

    Time frame: Day 1 to Day 366

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 22, 2020
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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