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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vaxart
• Treatments: Vaccines

Criteria

Inclusion Criteria

1. 18 - 75 years of age

2. Cohort 1 - Naive of any prior vaccination for the prevention of COVID-19

3. Cohort 2 - Have received prior immunizations (both doses) with an EUA (Emergency Use Authorized) or FDA approved mRNA vaccine for the prevention of COVID-19, at least 6 months prior to enrollment.

4. In stable and good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratory tests

5. Safety laboratory values within the following range criteria at screening:

1. Laboratory value of < grade 1 elevation from normal or decrease from normal with no clinical significance for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin,

2. Laboratory value of < grade 1 from normal with no clinical significance (NCS) for:

• decreased: albumin and total protein,

• elevated: amylase, blood urea nitrogen (BUN), and creatine phosphokinase (CPK) and creatine, and

• elevated or decreased: calcium, glucose, potassium, and sodium

3. Laboratory values within the range of normal for platelet counts and protocol specified coagulation tests

6. BMI between 17 and 30 kg/m2 at screening.

7. Capable of providing signed informed consent.

8. Available for all planned visits and phone calls, and willing to complete all protocol-defined procedures and assessments

9. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

10. Female participants must not be breastfeeding and must have a negative pregnancy test at screening and before each vaccination and fulfill one of the following criteria:

1. At least 1 year post-menopausal (Women under 60 years will need to verify post-menopausal status via a follicle stimulating hormone (FSH) test if another option to prevent potential pregnancy will not be utilized for 30 days prior to baseline vaccination and until 60 days after the last vaccination.)

2. Surgically sterile

3. Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to initial vaccination and until 60 days after the last vaccination.

4. A reliable form of contraception must be approved by the Investigator (e.g., double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches).

5. Not be sexually active (abstinent) or be in a relationship with partner who is sterile (must be discussed with site staff and documented).

Exclusion Criteria

1. Clinically significant acute illness within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam)

2. Current or known previous infection with COVID-19 (SARS-CoV-2) or receipt of any therapeutic for the prevention or treatment of COVID-19, middle-east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS). [EUA or FDA approved mRNA vaccines for the prevention of SARS-CoV-2 infection taken at least 6 months prior to enrollment are permitted in Cohort 2]

3. 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 guidance from the CDC (Center for Disease Control):

1. Cancer, including history of cancer or treatment within past 3 years

2. Chronic kidney disease

3. Chronic obstructive pulmonary disease (COPD)

4. Immunocompromised state from solid organ transplant, or other medical condition

5. Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies

6. Sickle cell disease

7. Uncontrolled type 2 diabetes mellitus

8. Asthma (moderate to severe)

9. Cerebrovascular disease

10. Cystic fibrosis

11. Uncontrolled hypertension or high blood pressure

12. Immunocompromised state from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines

13. Neurologic conditions, such as dementia

14. Liver disease

15. Pregnancy or breast feeding

16. Pulmonary fibrosis

17. Chronic smoking (≥ 1 cigarette per day)

18. Thalassemia

19. Type 1 diabetes mellitus

4. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.

5. Any condition that resulted in the absence or removal of the spleen.

6. Any other condition that in the clinical judgment of the Investigator would jeopardize the safety or rights of a participant participating in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints.

Diagnostic Assessments

7. Temperature ≥38.0ºC (100.4°F) within 24 hours prior to study vaccination.

8. Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at the screening visit.

9. Stool sample with occult blood at screening.

10. Receipt of a licensed influenza vaccine within 14 days prior to baseline vaccination or another licensed vaccine within 28 days prior to baseline vaccination, or planned administration during the study active period.

11. Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 1 week before vaccination or planned use during the active study period.

12. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 1 week before vaccination or planned use during the active study period.

13. Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 14 days before vaccination or planned use during the active study period.

14. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs), sulfonylureas, and angiotensin II blockers within 1 week before vaccination or planned use during the active study period.

15. Positive urine drug screen for drugs of abuse at screening

16. Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination, or planned use within the duration of the study.

17. Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.

18. Any significant hospitalization within the last year which in the opinion of the Investigator or Sponsor could interfere with study participation.

19. History of drug, alcohol or chemical abuse within 1 year of screening.

20. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.

21. Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:

1. Family or personal history of bleeding or thrombosis

2. History of heparin-related thrombotic events, and/or receiving heparin treatments

3. History of autoimmune or inflammatory disease

4. 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