Healthy VolunteersPhase 1NCT04679909
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
A Phase 1 study testing AdCOVID in people with Healthy Volunteers, run by Altimmune, Inc. at 6 sites in United States.
Trial summary
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AdCOVID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Feb 2021to 21 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Optimal Research
Austin, Texas, 78705
AGA Clinical Trials
Hialeah, Florida, 33012
Optimal Research
Melbourne, Florida, 32934
Optimal Research
Peoria, Illinois, 61614
Optimal Research
Rockville, Maryland, 20850
Clinical Trials of Texas
San Antonio, Texas, 78229
About this study
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
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- AdCOVID, Placebo
- Keywords
- COVID-19, SARS-CoV-2, Intranasal Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCOVIDBiological
Administered intranasally
PlaceboOther
Administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Single Low Dose AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Single Medium Dose AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Single High Dose AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Two Low Doses AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Two Medium Doses AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Two High Doses AdCOVID | Experimental | Not described Receives: Biological: AdCOVID |
| Single Dose Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Two Dose Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Counts and percentages of subjects with local and systemic events
Measured: For 7 days after vaccination
Adverse Events (AEs)
Counts and percentages of subjects with AEs
Measured: Day 1 to Day 57
Secondary outcomes (2)
Anti-SARS-CoV-2 spike IgG antibody levels
Measured: Day 1 to Day 366
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
Measured: Day 1 to Day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start25 Feb 2021
- Primary completion1 Dec 2021
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679909
- Sponsor's protocol ID
- ALT-501-101
- Status last verified
- Aug 2023
- First submitted
- 21 Dec 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04679909
- Acronym / sponsor ID
- ALT-501-101
- Conditions
- Healthy Volunteers
- Keywords
- COVID-19, SARS-CoV-2, Intranasal Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single Low Dose AdCOVID | Experimental | Biological: AdCOVID |
| Single Medium Dose AdCOVID | Experimental | Biological: AdCOVID |
| Single High Dose AdCOVID | Experimental | Biological: AdCOVID |
| Two Low Doses AdCOVID | Experimental | Biological: AdCOVID |
| Two Medium Doses AdCOVID | Experimental | Biological: AdCOVID |
| Two High Doses AdCOVID | Experimental | Biological: AdCOVID |
| Single Dose Placebo | Placebo comparator | Other: Placebo |
| Two Dose Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdCOVIDAdministered intranasally | Biological | Single High Dose AdCOVID, Single Low Dose AdCOVID, Single Medium Dose AdCOVID, Two High Doses AdCOVID, Two Low Doses AdCOVID, Two Medium Doses AdCOVID |
| PlaceboAdministered intranasally | Other | Single Dose Placebo, Two Dose Placebo |
Primary outcome
Reactogenicity
Time frame: For 7 days after vaccination
Counts and percentages of subjects with local and systemic events
Adverse Events (AEs)
Time frame: Day 1 to Day 57
Counts and percentages of subjects with AEs
2 secondary outcomes
Anti-SARS-CoV-2 spike IgG antibody levels
Time frame: Day 1 to Day 366
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
Time frame: Day 1 to Day 366
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AdCOVID in people with Healthy Volunteers, run by Altimmune, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactogenicity (time frame: For 7 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.