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CompletedNCT04679909Updated Aug 14, 2023

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

A Phase 1 interventional study of AdCOVID and Placebo in Healthy Volunteers, sponsored by Altimmune, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Altimmune, Inc. · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Dec 2021, 4 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers

Browse trials for

Keywords

  • COVID-19
  • SARS-CoV-2
  • Intranasal Vaccine
03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 92 is close to the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Altimmune, Inc. is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 4 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Single Low Dose AdCOVID

    Biological: AdCOVID

  • Experimental
    Single Medium Dose AdCOVID

    Biological: AdCOVID

  • Experimental
    Single High Dose AdCOVID

    Biological: AdCOVID

  • Experimental
    Two Low Doses AdCOVID

    Biological: AdCOVID

  • Experimental
    Two Medium Doses AdCOVID

    Biological: AdCOVID

  • Experimental
    Two High Doses AdCOVID

    Biological: AdCOVID

  • Placebo comparator
    Single Dose Placebo

    Other: Placebo

  • Placebo comparator
    Two Dose Placebo

    Other: Placebo

Interventions

  • BiologicalAdCOVID

    Administered intranasally

  • OtherPlacebo

    Administered intranasally

06

What researchers measure

Primary outcomes

  1. Reactogenicity

    Counts and percentages of subjects with local and systemic events

    Time frame: For 7 days after vaccination

  2. Adverse Events (AEs)

    Counts and percentages of subjects with AEs

    Time frame: Day 1 to Day 57

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

07

Study locations

6 sites
  • AGA Clinical Trials
    Hialeah, Florida 33012, United States
  • Optimal Research
    Melbourne, Florida 32934, United States
  • Optimal Research
    Peoria, Illinois 61614, United States
  • Optimal Research
    Rockville, Maryland 20850, United States
  • Optimal Research
    Austin, Texas 78705, United States
  • Clinical Trials of Texas
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in Dec 2021, 9 months.

Of 176 industry-sponsored phase 1 interventional studies under COVID-19, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 9 months is above that.

Counting every sponsor, half of 314 studies reached it within 8 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2020
First posted
Dec 22, 2020
StartActual
Feb 25, 2021
Primary completionActual
Dec 1, 2021
CompletionActual
Dec 21, 2022
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04679909
Lead sponsor
Altimmune, Inc.
Responsible party
Sponsor
First posted
Dec 22, 2020
Start date
Feb 25, 2021
Primary completion
Dec 1, 2021
Completion
Dec 21, 2022
Last update
Aug 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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