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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05067933

Run by

Vaxart

People needed

66

Starts

2021-10-22

Expected to finish

2023-05-09

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 - 75 years of age (inclusive) at the time of signing the Informed Consent Form (ICF).
• Cohort 1 ONLY - Naive of any prior vaccination for the prevention of COVID-19 (tested using a rapid antibody test) at screening and within 7 days prior to the enrollment (Day 1).
• Cohort 2 ONLY - Have received prior immunizations (both doses) with an EUA or FDA approved mRNA vaccine for the prevention of COVID-19, at least 6 months prior to enrollment (Day 1).
• In stable and good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratory tests as determined by the Investigator.
• Safety laboratory values1 within the following range criteria at screening:
• Laboratory values within normal range or grade 1 outside the range of normal with no clinical significance (NCS) for the following analytes:, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin, blood urea nitrogen (BUN), creatinine, glucose, potassium, and sodium
• Laboratory values within normal range for platelet counts2 and the following coagulation tests: PT/INR, aPTT and fibrinogen
• Body mass index (BMI) between 17 and 32 kg/m2 at screening.
• Capable of providing signed informed consent.
• Available for all planned visits and phone calls, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per vaccine dose).
• Gender and Reproductive Considerations
• Male or female participants. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Appendix 4 (Section 9.4).
• 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:
• At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause).
• 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.
• Surgically sterile
• Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to initial vaccination and until 60 days after the last vaccination.
• 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).
• 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 Medical Conditions
• 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) (assessment may be repeated during screening period).
• Current or known previous infection with 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]
• 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 Centers for Disease Control and Prevention (CDC):
• Cancer, including history of cancer or treatment within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
• Chronic kidney disease

Where it is running

• Ark Clinical Research — Long Beach, California, United States
• AMR Wichita East — Wichita, Kansas, United States
• Velocity Clinical Research, Inc, — Cleveland, Ohio, United States
• AMR Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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