Oral Vaccine for COVID-19

Recruiting at 144 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vaxart

Must not be taking: Antibiotics, Antacids, NSAIDs, others

Disqualifiers: Autoimmune, Immunodeficiency, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.1 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19).

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, such as antibiotics, proton pump inhibitors, H2 blockers, antacids, and nonsteroidal anti-inflammatory drugs, at least 7 days before the study and during the study. Additionally, medications that affect the immune system or gastrointestinal motility must be stopped within specific timeframes before the study. Please consult with the study team for guidance on your specific medications.

What data supports the effectiveness of the oral COVID-19 vaccine treatment VXA-CoV2-3.1?

Research on similar oral vaccines shows they can trigger strong immune responses and protect against COVID-19 in animal studies, suggesting potential effectiveness for VXA-CoV2-3.1. ^{1 2 3 4 5}

What makes the oral COVID-19 vaccine VXA-CoV2-3.1 unique compared to other COVID-19 treatments?

The oral COVID-19 vaccine VXA-CoV2-3.1 is unique because it is administered by mouth, unlike most COVID-19 vaccines which are given as injections. This could make it easier to distribute and administer, especially in areas with limited healthcare resources. ^{6 7 8 9 10}

Research Team

James Cummings, MD

Principal Investigator

Vaxart, Inc.

Eligibility Criteria

This trial is for adults who have already been vaccinated against COVID-19. Participants should be in good health and not currently infected with COVID-19. The full eligibility criteria are not provided, so additional requirements may apply.

Inclusion Criteria

I agree to use effective birth control before and after the study.

I have completed the COVID-19 vaccination series with 2 or more mRNA doses.

I tested negative for COVID-19 before starting the trial.

Exclusion Criteria

I have not had any serious health or mental issues needing frequent treatment in the last 3 months, except well-controlled diabetes.

Any known allergies to components contained in the investigational product (including fish gelatin) or comparator or latex allergy (including polyethylene glycol [PEG] allergies) and/or history of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain

I haven't taken antibiotics or stomach acid-related meds in the last 7 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the VXA-CoV2-3.1 oral vaccine or the COMIRNATY® injectable vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of treatment-emergent adverse events

12 months

Treatment Details

Interventions

• VXA-CoV2-3.1 (Virus Therapy)

Trial Overview The study is testing the effectiveness of a new oral vaccine tablet called VXA-CoV2-3.1 compared to an existing mRNA booster shot, COMIRNATY®, for preventing symptoms of COVID-19 in previously immunized adults.

Participant Groups

Group I: VXA-CoV2-3.1 Experimental Treatment 1 Intervention

Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 tablet oral vaccine.

Group II: COMIRNATY® Active Control 1 Intervention

Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® injectable COVID-19 vaccine.

Who Is Running the Clinical Trial?

Vaxart

Lead Sponsor

Trials

22

Recruited

11,400+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Oral delivery of a chitosan adjuvanted COVID-19 vaccine provides long-lasting and broad-spectrum protection against SARS-CoV-2 variants of concern in golden hamsters. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protective Efficacy of Gastrointestinal SARS-CoV-2 Delivery against Intranasal and Intratracheal SARS-CoV-2 Challenge in Rhesus Macaques. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Oral Administration of Universal Bacterium-Vectored Nucleocapsid-Expressing COVID-19 Vaccine is Efficacious in Hamsters. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Full efficacy and long-term immunogenicity induced by the SARS-CoV-2 vaccine candidate MVA-CoV2-S in mice. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Oral Immunization with rVSV Bivalent Vaccine Elicits Protective Immune Responses, Including ADCC, against Both SARS-CoV-2 and Influenza A Viruses. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of sequential intravenous/oral moxifloxacin therapy in pneumonia: results of the first post-marketing surveillance study with intravenous moxifloxacin in hospital practice. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Opportunities for Oral Antibiotic Therapy in Bone and Joint Infections. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of enteral feeding on the oral bioavailability of moxifloxacin in healthy volunteers. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Moxifloxacin--a new fluoroquinolone antibacterial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical and Economic Impact of Implementing OVIVA Criteria on Patients With Bone and Joint Infections in Outpatient Parenteral Antimicrobial Therapy. [2021]