10400 Participants Needed

Oral Vaccine for COVID-19

Recruiting at 144 trial locations
MD
CH
MA
ND
Overseen ByNick D'Amato
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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-CoV2-3.1.12345

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.678910

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-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19).In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.

Research Team

JC

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.
See 5 more

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.
See 25 more

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 COMIRNATYยฎ 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
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, COMIRNATYยฎ, for preventing symptoms of COVID-19 in previously immunized adults.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: VXA-CoV2-3.3Experimental Treatment1 Intervention
If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of VXA-CoV2-3.3 (KP.2 vaccine).
Group II: VXA-CoV2-3.1 Safety Sentinel CohortExperimental Treatment1 Intervention
Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine.
Group III: COMIRNATYยฎ Safety Sentinel CohortActive Control1 Intervention
Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATYยฎ (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine.
Group IV: COMIRNATYยฎActive Control1 Intervention
If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of 2024-2025 formula of COMIRNATYยฎ mRNA COVID-19 injectable vaccine.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vaxart

Lead Sponsor

Trials
22
Recruited
11,400+

Findings from Research

The study identified an effective oral COVID-19 vaccine candidate, rVSVฮ”G-Sdelta, which produced long-lasting neutralizing antibodies against multiple SARS-CoV-2 variants for up to one year.
In tests on golden hamsters, this vaccine demonstrated significant cross-protection against various strains of SARS-CoV-2, reducing viral replication and improving lung health after infection.
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.Wang, S., Cui, H., Zhang, C., et al.[2023]
The study found that administering live SARS-CoV-2 orally in rhesus macaques resulted in weak immunogenicity, with limited virus replication in the gastrointestinal tract and minimal mucosal antibody response.
Despite the weak immune response, there was some partial protection against respiratory SARS-CoV-2 challenges, indicating that while the oral vaccine shows potential, further optimization of the formulation and delivery method is necessary.
Protective Efficacy of Gastrointestinal SARS-CoV-2 Delivery against Intranasal and Intratracheal SARS-CoV-2 Challenge in Rhesus Macaques.Yu, J., Collins, ND., Mercado, NB., et al.[2022]
The oral delivery of the rLVS ฮ”capB/MN COVID-19 vaccine effectively protects hamsters from severe disease caused by high-dose SARS-CoV-2, showing comparable efficacy to other administration methods like intradermal and intranasal routes.
This vaccine targets conserved proteins of the virus, making it potentially effective against emerging variants, and its oral formulation could significantly improve vaccination rates, especially in low-resource settings where injectable vaccines are challenging to administer.
Oral Administration of Universal Bacterium-Vectored Nucleocapsid-Expressing COVID-19 Vaccine is Efficacious in Hamsters.Jia, Q., Bielefeldt-Ohmann, H., Maison, RM., et al.[2023]

References

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]
Protective Efficacy of Gastrointestinal SARS-CoV-2 Delivery against Intranasal and Intratracheal SARS-CoV-2 Challenge in Rhesus Macaques. [2022]
Oral Administration of Universal Bacterium-Vectored Nucleocapsid-Expressing COVID-19 Vaccine is Efficacious in Hamsters. [2023]
Full efficacy and long-term immunogenicity induced by the SARS-CoV-2 vaccine candidate MVA-CoV2-S in mice. [2022]
Oral Immunization with rVSV Bivalent Vaccine Elicits Protective Immune Responses, Including ADCC, against Both SARS-CoV-2 and Influenza A Viruses. [2023]
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]
Evaluation of Opportunities for Oral Antibiotic Therapy in Bone and Joint Infections. [2023]
Effects of enteral feeding on the oral bioavailability of moxifloxacin in healthy volunteers. [2018]
Moxifloxacin--a new fluoroquinolone antibacterial. [2018]
10.United Statespubmed.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]
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