Covid19Phase 1NCT04563702
Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects
A Phase 1 study testing VXA-CoV2-1 in people with Covid19, run by Vaxart at 1 site in United States.
Trial summary
VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- VXA-CoV2-1
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 10 Oct 2021
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between the ages of 18 to 54 years, inclusive.
- Negative for SARS-CoV-2 infection at the time of screening
- In generally good health, without significant medical illness
- Demonstrates comprehension of the protocol procedures and is able to provide written informed consent.
- Available for all planned visits and willing to complete all protocol defined procedures and assessments
- Body mass index between 17 and 30 kg/m2 at screening.
- Female subjects must have a negative pregnancy test at screening and before each vaccination and fulfill an acceptable method of birth control (per protocol)
Who cannot join
- Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
- Is in a current occupation with high risk of exposure to SARS-CoV-2
- Individuals with the following underlying medical conditions who are at higher risk (or might be at higher risk) of severe illness from COVID-19 per the CDC's guidance
- Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
- Any condition that resulted in the absence or removal of the spleen.
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- Positive HIV, HBsAg or HCV tests at the screening visit.
- Stool sample with occult blood at screening.
- Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 7 days before vaccination
- Use of antibiotics, proton pump inhibitors, H2 blockers or antacids or medications known to affect the immune function within 7 to 14 days before vaccination
- Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 7 days before vaccination
- Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness
- History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug screen for drugs of abuse at screening
- History of hypersensitivity or allergic reaction to any component of the investigational vaccine
- Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a subject participating in the trial, would render the subject unable to comply with the protocol or would interfere with the evaluation of the study endpoints.
- For subjects being re-evaluated for participation in the VXA-CoV2-1.1-S boost substudy the following will also be exclusionary:
- Laboratory values outside the range of normal for platelet counts and the following coagulation tests: PT/INR, aPTT, fibrinogen, and D-dimer.
- Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
- Family or personal history of bleeding or thrombosis f. History of heparin-related thrombotic events, and/or receiving heparin treatments g. History of autoimmune or inflammatory disease h. Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:
- Recent surgery other than removal/biopsy of cutaneous lesions
- Immobility (confined to bed or wheelchair for 3 or more successive days)
- Head trauma with loss of consciousness or documented brain injury
- Receipt of anticoagulants for prophylaxis of thrombosis
- Recent clinically significant infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers VXA-CoV2-1.1-S Boost Substudy: Boost at 1 Year Post Initial Vaccination With an Adenoviral-Vector Based Vaccine VXA-CoV2-1.1-S Expressing a SARS-CoV-2 S Protein in a Subset of Subjects
VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to evaluate the safety and immunogenicity of VXA-CoV2-1 vaccine with repeat dosing at multiple dose levels. Safety and immunogenicity will be evaluated for up to 12 months after the second dose of VXA-CoV2-1.
Read the detailed description
This is an open-label, dose-ranging trial to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers aged 18 - 54 yrs old, inclusive, will be enrolled into the study. Participants will receive an oral dose of vaccine at Days 1 and a subject will also receive a second dose at Day 29; total study period will last ~ 2 months during the active phase, with a total 12 month safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the study active and follow-up periods. Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study follow-up period.
Approximately 10 healthy male and female adult volunteers 18 to 54 years old who were enrolled in the main study will be included in a boost extension substudy for an additional 12 months from dosing for a total participation period of 24-25 months.
- Conditions
- Covid19
- Being tested
- VXA-CoV2-1
- Keywords
- VXA-C0V2-1, Vaxart oral vaccine, tablet vaccine, VXA-C0V2-1.1, Boost
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXA-CoV2-1Biological
non replicating Ad5 adjuvanted oral tableted vaccine
| Study group | Role | What they receive |
|---|---|---|
| Low Dose VXA-CoV2-1 | Experimental | Low dose (1E10 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1. A subset will also receive a second dose at Day 29 Receives: Biological: VXA-CoV2-1 |
| High Dose | Experimental | High Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1 Receives: Biological: VXA-CoV2-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited symptoms of reactogenicity
Subject reported symptoms of local and systemic reactogenicity
Measured: Day 1 through Day 8 post each immunization
Grade of solicited symptoms of reactogenicity
Subject reported symptoms of local and systemic reactogenicity
Measured: Day 1 through Day 8 post each immunization
Frequency of unsolicited adverse events
Any adverse events observed or reported following vaccination
Measured: Day 1 through Day 29 post each immunization
Grade of unsolicited adverse events
Any adverse events observed or reported following vaccination
Measured: Day 1 through Day 29 post each immunization
Frequency of serious adverse events (SAEs)
Any adverse events reported following vaccination meeting definition of serious
Measured: Day 1 through Day 390
Frequency of medically-attended adverse events (MAAEs)
Any adverse events reported following vaccination meeting definition of serious
Measured: Day 1 through Day 390
Secondary outcomes (4)
SARS-CoV-2 specific IgG/IgA
SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 1 through Day 390
Neutralizing antibody titers to SARS-CoV-2
serum based assay of Ab titers
Measured: Day 1 through Day 390
Antigen-specific IgG/IgA antibody secreting (ASCs)
ASCs by ELISpot
Measured: Day 1 through Day 44
Th1/Th2 polarization
Flow Cytometry
Measured: Day 1 through Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 Sep 2020
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, repeat dose, dose ranging
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Cummings, MD, Study director, Vaxart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563702
- Sponsor's protocol ID
- VXA-COV2-101
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2020
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan on how to share individual subject's outcomes will be defined within the next few months.
Publications
Langel SN, Johnson S, Martinez CI, Tedjakusuma SN, Peinovich N, Dora EG, Kuehl PJ, Irshad H, Barrett EG, Werts AD, Tucker SN. Adenovirus type 5 SARS-CoV-2 vaccines delivered orally or intranasally reduced disease severity and transmission in a hamster model. Sci Transl Med. 2022 Aug 17;14(658):eabn6868. doi: 10.1126/scitranslmed.abn6868. Epub 2022 Aug 17.
PubMed 35511920
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers VXA-CoV2-1.1-S Boost Substudy: Boost at 1 Year Post Initial Vaccination With an Adenoviral-Vector Based Vaccine VXA-CoV2-1.1-S Expressing a SARS-CoV-2 S Protein in a Subset of Subjects
- ClinicalTrials.gov ID
- NCT04563702
- Acronym / sponsor ID
- VXA-COV2-101
- Conditions
- Covid19
- Keywords
- VXA-C0V2-1, Vaxart oral vaccine, tablet vaccine, VXA-C0V2-1.1, Boost
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 24 Sep 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.
VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to evaluate the safety and immunogenicity of VXA-CoV2-1 vaccine with repeat dosing at multiple dose levels. Safety and immunogenicity will be evaluated for up to 12 months after the second dose of VXA-CoV2-1.
Detailed description
This is an open-label, dose-ranging trial to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers aged 18 - 54 yrs old, inclusive, will be enrolled into the study. Participants will receive an oral dose of vaccine at Days 1 and a subject will also receive a second dose at Day 29; total study period will last ~ 2 months during the active phase, with a total 12 month safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the study active and follow-up periods. Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study follow-up period.
Approximately 10 healthy male and female adult volunteers 18 to 54 years old who were enrolled in the main study will be included in a boost extension substudy for an additional 12 months from dosing for a total participation period of 24-25 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, repeat dose, dose ranging
| Arm | Type | Receives |
|---|---|---|
| Low Dose VXA-CoV2-1 | Experimental | Biological: VXA-CoV2-1Low dose (1E10 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1. A subset will also receive a second dose at Day 29 |
| High Dose | Experimental | Biological: VXA-CoV2-1High Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1 |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female between the ages of 18 to 54 years, inclusive.
- Negative for SARS-CoV-2 infection at the time of screening
- In generally good health, without significant medical illness
- Demonstrates comprehension of the protocol procedures and is able to provide written informed consent.
- Available for all planned visits and willing to complete all protocol defined procedures and assessments
Key exclusion criteria (25 listed)
- Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
- Is in a current occupation with high risk of exposure to SARS-CoV-2
- Individuals with the following underlying medical conditions who are at higher risk (or might be at higher risk) of severe illness from COVID-19 per the CDC's guidance
- Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
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 |
|---|---|---|
| VXA-CoV2-1non replicating Ad5 adjuvanted oral tableted vaccine | Biological | High Dose, Low Dose VXA-CoV2-1 |
Primary outcome
Frequency of solicited symptoms of reactogenicity
Time frame: Day 1 through Day 8 post each immunization
Subject reported symptoms of local and systemic reactogenicity
Grade of solicited symptoms of reactogenicity
Time frame: Day 1 through Day 8 post each immunization
Subject reported symptoms of local and systemic reactogenicity
Frequency of unsolicited adverse events
Time frame: Day 1 through Day 29 post each immunization
Any adverse events observed or reported following vaccination
Grade of unsolicited adverse events
Time frame: Day 1 through Day 29 post each immunization
Any adverse events observed or reported following vaccination
Frequency of serious adverse events (SAEs)
Time frame: Day 1 through Day 390
Any adverse events reported following vaccination meeting definition of serious
Frequency of medically-attended adverse events (MAAEs)
Time frame: Day 1 through Day 390
Any adverse events reported following vaccination meeting definition of serious
4 secondary outcomes
SARS-CoV-2 specific IgG/IgA
Time frame: Day 1 through Day 390
Neutralizing antibody titers to SARS-CoV-2
Time frame: Day 1 through Day 390
Antigen-specific IgG/IgA antibody secreting (ASCs)
Time frame: Day 1 through Day 44
Th1/Th2 polarization
Time frame: Day 1 through Day 44
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 21 Jun 2024.
- Derived from this study: PubMed 35511920Langel SN, Johnson S, Martinez CI, Tedjakusuma SN, Peinovich N, Dora EG, Kuehl PJ, Irshad H, Barrett EG, Werts AD, Tucker SN. Adenovirus type 5 SARS-CoV-2 vaccines delivered orally or intranasally reduced disease severity and transmission in a hamster model. Sci Transl Med. 2022 Aug 17;14(658):eabn6868. doi: 10.1126/scitranslmed.abn6868. Epub 2022 Aug 17.
- Individual participant dataSharing planned: Undecided. A plan on how to share individual subject's outcomes will be defined within the next few months.
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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.
James Cummings, MD study director
Vaxart, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VXA-CoV2-1 in people with Covid19, run by Vaxart at 1 site 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 7 inclusion and 25 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Frequency of solicited symptoms of reactogenicity (time frame: Day 1 through Day 8 post each immunization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563702, which also lists 1 linked publication.
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 21 Jun 2024.