NCT05067933 is a Phase 2 clinical trial of VXA-CoV2-1.1-S in COVID-19, sponsored by Vaxart.

Who is sponsoring NCT05067933?

NCT05067933 is sponsored by Vaxart.

What drugs are being tested in NCT05067933?

Interventions in NCT05067933: VXA-CoV2-1.1-S, Placebo Tablets.

Is NCT05067933 still recruiting?

NCT05067933 is currently terminated. Last updated 13 April 2025.

Are results published for NCT05067933?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-04-13 · How we verify

NCT05067933

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine

Terminated Phase 2 Results posted Last updated 13 April 2025

What this trial tests

Phase 2 trial testing VXA-CoV2-1.1-S in COVID-19 in 66 participants. Terminated before completion.

Timeline

22 October 2021

Primary endpoint
10 June 2022

9 May 2023

Quick facts

Lead sponsor	Vaxart
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	prevention
Enrollment	66
Start date	22 October 2021
Primary completion	10 June 2022
Estimated completion	9 May 2023
Sites	4 locations across United States

Drugs / interventions tested

VXA-CoV2-1.1-S — full drug profile →
Placebo Tablets — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Vaxart — full company profile →

Who can join

Adults 18 to 75, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced a Solicited Symptom of Reactogenicity Primary · Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Solicited symptoms of reactogenicity were predefined systemic signs and symptoms of reactogenicity for which the participant was specifically questioned, and which were noted by the participant in their daily Solicited Symptom Diary for 7 days after each vaccination, including: * fever (any temperature 100°F or higher) * headache * myalgia (muscle pain) * abdominal pain * anorexia (defined and not eating) * nausea * vomiting * diarrhea * malaise/fatigue

Dose 1

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	16
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	10

Dose 2

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	13
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	4

Severity of Solicited Symptoms of Reactogenicity Primary · Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Dose 1

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	11
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	8
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	5
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Dose 2

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	7
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	3
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	6
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	1
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Number of Participants Who Experienced an Unsolicited Treatment-emergent Adverse Event (TEAE) During the Active Treatment Period Primary · Day 1 to Day 57

A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, occurring after first dose of study drug. A serious TEAE was any TEAE that met any of the following criteria: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent or significant disability/incapacity. * Was a congenital anomaly/birth defect. * Was a suspected transmission of any infectious agent via a m

Any TEAE

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	10
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	4

Any Serious TEAE

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	1
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Severity of Unsolicited TEAEs During the Active Treatment Period Primary · Day 1 to Day 57

All unsolicited TEAEs during the active treatment period were assessed by the investigator using the below scale: * Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities. * Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning. * Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating. * Life Threateni

Any TEAE

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	4
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	3
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	4
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	1
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Any Serious TEAE

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	1
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Number of Participants Who Experienced a Medically Attended Adverse Event (MAAE) During the Active Treatment Period Primary · Day 1 to Day 57

MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic illness/diseases (NOCI) and adverse events of special interest (AESIs) were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	6
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Severity of MAAEs During the Active Treatment Period Primary · Day 1 to Day 57

All MAAEs during the active treatment period were assessed by the investigator using the below scale: * Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities. * Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning. * Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating. * Life Threatening: Any adve

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0

Number of Participants Who Experienced a MAAE During the Safety Follow-up Period Secondary · From last dose up to 12 months post-last dose

MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. NOCI and AESIs were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	5
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	2

Severity of MAAEs During the Safety Follow-up Period Secondary · From last dose up to 12 months post-last dose

All MAAEs during the safety follow-up period were assessed by the investigator using the below scale: * Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities. * Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning. * Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating. * Life Threatening: Any adve

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	1
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Number of Participants Who Experienced a Serious TEAE During the Safety Follow-up Period Secondary · From last dose up to 12 months post-last dose

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	3
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	0

Severity of Serious TEAEs During the Safety Follow-up Period Secondary · From last-dose up to 12 months post-last dose

All serious TEAEs during the active treatment period were assessed by the investigator using the below scale: * Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities. * Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning. * Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating. * Life Threatening:

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	0
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	2
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	1

Levels of SARS-CoV2-specific Immunoglobulin G Spike (IgG-S) Antibodies by Mesoscale Discovery (MSD) Assay Secondary · Day 1, Day 29 and Day 57

SARS-CoV2-specific IgG-S antibody levels were measured on specific timepoints via MSD assay. For results below the lower limit of quantification (LLOQ), the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the upper limit of quantification (ULOQ), the value was replaced with the numeric portion of the original result.

Day 1

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	4708.7	1555.28 – 14255.88
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	6323.8	1721.12 – 23235.26

Day 29

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	6693.2	2379.57 – 18826.24
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	10097.1	2880.93 – 35388.51

Day 57

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	12348.6	4974.39 – 30654.39
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	12868.1	4124.72 – 40145.35

Levels of SARS-CoV2-specific Immunoglobulin G Nucleocapsid (IgG-N) Antibodies by MSD Assay Secondary · Day 1, Day 29 and Day 57

SARS-CoV2-specific IgG-N antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.

Day 1

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	360.3	189.03 – 686.76
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	1516	560.05 – 4105.41

Day 29

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	593.3	258.49 – 1361.80
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	1301.6	511.21 – 3314.18

Day 57

Group	Value	95% CI
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log	898.2	376.83 – 2140.91
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log	1192.4	504.15 – 2820.21

Adverse events — posted to ClinicalTrials.gov

Time frame: Active Study Period: Day 1 to Day 57; Safety Follow-up Period: Last-dose to up to 12 months post-last dose. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Study Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log

Serious: 1/45 (2%)

Deaths: 0/45

Active Study Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log

Serious: 0/21 (0%)

Deaths: 0/21

Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log

Serious: 3/44 (7%)

Deaths: 1/44

Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log

Serious: 0/21 (0%)

Deaths: 0/21

Serious adverse events (8 terms)

Reaction	System	Active Study Period: VXA-C…	Active Study Period: VXA-C…	Safety Follow-up Period: V…	Safety Follow-up Period: V…
Hospitalization	Surgical and medical procedures	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Active Study Period: VXA-C…	Active Study Period: VXA-C…	Safety Follow-up Period: V…	Safety Follow-up Period: V…
Headache	Nervous system disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Amylase increased	Investigations	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Thirst	General disorders	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Hospitalization, Iron deficiency anaemia, Cardiac arrest, Appendicitis, Pleural effusion, Pneumonitis, Pulmonary embolism, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT05067933 adverse events section.

Sponsor's own description

Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19. Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of COVID-19 vaccines.
Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
Adenovirus type 5 SARS-CoV-2 vaccines delivered orally or intranasally reduced disease severity and transmission in a hamster model.
Langel SN, Johnson S, Martinez CI, Tedjakusuma SN, et al · · 2022 · cited 103× · PMID 35511920 · DOI 10.1126/scitranslmed.abn6868
Mucosal Vaccines, Sterilizing Immunity, and the Future of SARS-CoV-2 Virulence.
Focosi D, Maggi F, Casadevall A. · · 2022 · cited 73× · PMID 35215783 · DOI 10.3390/v14020187
Replicating Viral Vector-Based Vaccines for COVID-19: Potential Avenue in Vaccination Arena.
Chavda VP, Bezbaruah R, Athalye M, Parikh PK, et al · · 2022 · cited 40× · PMID 35458489 · DOI 10.3390/v14040759
An Overview of Recent Insights into the Response of TLR to SARS-CoV-2 Infection and the Potential of TLR Agonists as SARS-CoV-2 Vaccine Adjuvants.
Kayesh MEH, Kohara M, Tsukiyama-Kohara K. · · 2021 · cited 39× · PMID 34835108 · DOI 10.3390/v13112302
A Narrative Review of COVID-19 Vaccines.
Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
Vaccine adjuvants for infectious disease in the clinic.
Goetz M, Thotathil N, Zhao Z, Mitragotri S. · · 2024 · cited 29× · PMID 39036089 · DOI 10.1002/btm2.10663
Activation of Innate Immunity by Therapeutic Nucleic Acids.
Bishani A, Chernolovskaya EL. · · 2021 · cited 26× · PMID 34948156 · DOI 10.3390/ijms222413360

Verify or expand the search:

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Other Vaxart trials

Trials by the same sponsor.

NCT06944717 — A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years · Phase 1 · active not recruiting
NCT07254728 — A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing I · Phase 1 · completed
NCT05626803 — A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers · Phase 2 · completed
NCT05213728 — A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-v · Phase 1 · completed
NCT05212168 — Norovirus Challenge Study · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05067933 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vaxart
Last refreshed: 13 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05067933.

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