A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

Start Date26 Jan 2023

Sponsor / Collaborator

Vaxart, Inc.

NCT05213728

/ CompletedPhase 1

A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered to Healthy Adult Volunteers

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

Start Date24 Jan 2022

Sponsor / Collaborator

Vaxart, Inc.

NCT05212168

/ CompletedPhase 1/2

A Phase 2b Double-Blinded, Randomized, Placebo-Controlled, Human Norovirus GI.1 (Norwalk Virus Inoculum) Challenge Study Following Administration of an Oral, Single-dose Norovirus Vaccine Expressing GI.1 VP1 and dsRNA Adjuvant to Protect Against Norovirus Gastroenteritis (NVG) in Healthy Adult Volunteers

This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo.
* Arm 1: VXA-G1.1-NN oral vaccine tablets [1x1011 IU±0.5 log]
* Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets
Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.

Start Date27 Dec 2021

Sponsor / Collaborator

Vaxart, Inc.

100 Clinical Results associated with Monovalent norovirus Vaccine(Vaxart)

100 Translational Medicine associated with Monovalent norovirus Vaccine(Vaxart)

100 Patents (Medical) associated with Monovalent norovirus Vaccine(Vaxart)

Literatures (Medical) associated with Monovalent norovirus Vaccine(Vaxart)

05 Mar 2025·Science Translational Medicine

An oral norovirus vaccine tablet was safe and elicited mucosal immunity in older adults in a phase 1b clinical trial

Article

Author: Cummings, James F. ; Cuevas-Juárez, Esmeralda ; Greco, Susan N. ; Pasetti, Marcela F. ; Shriver, Mallory ; Tedjakusuma, Sarah N. ; Tucker, Sean N. ; Gutierrez, Samanta ; Lester, Colin A. ; Braun, Molly R. ; Neuhaus, Elena D. ; Flitter, Becca A.

Norovirus is a leading cause of acute gastroenteritis globally, with infections in older adults associated with heightened severity and increased risk of mortality. Currently, no licensed vaccines are available to prevent norovirus infection. We developed an orally administered vaccine tablet (VXA-G1.1-NN) that delivers a nonreplicating adenoviral vector expressing norovirus GI.1 major capsid protein VP1 to the small intestine. Here, we report safety and immunogenicity results of a randomized, double-blind, placebo-controlled clinical trial (NCT04854746) that investigated the oral administration of VXA-G1.1-NN in two groups of healthy older adults aged 55 to 65 and 66 to 80 years. VXA-G1.1-NN was administered orally at three dose levels by prime and boost, 28 days apart. Immunization was well tolerated regardless of dose, with mild to moderate reported solicited symptoms and no related serious or grade 3 adverse events. Oral delivery of VXA-G1.1-NN elicited VP1-specific serum immunoglobulin G (IgG) and IgA and functional antibodies in a dose-dependent manner 28 days postvaccination and remained above baseline for 210 days. Moreover, robust circulating VP1-specific IgA antibody-secreting cells were detected 1 week postvaccination along with IgA + plasmablasts expressing the mucosal-homing marker α4β7. VP1-specific IgA increased in saliva and nasal lining fluid 28 days postvaccination in both age groups and remained above baseline concentrations through 210 days, demonstrating durable mucosal responses. This clinical trial established that oral administration of VXA-G1.1-NN is safe, well tolerated, and induces robust systemic and mucosal immune responses in adults up to 80 years old.

News (Medical) associated with Monovalent norovirus Vaccine(Vaxart)

15 Oct 2024

·www.globenewswire.com

Vaxart to Present Norovirus Data at IDWeek 2024 Underscoring Commitment to Address Significant Unmet Need

SOUTH SAN FRANCISCO, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it will present research demonstrating the potential of its norovirus oral pill vaccine candidate at IDWeek taking place October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles. With no currently approved vaccines against norovirus, Vaxart remains committed to progressing what it believes to be the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. Norovirus sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. Adults ≥65 years old are at high-risk for severe symptoms and clinical outcomes including longer disease duration and death. The annual disease burden from norovirus in the United States is estimated to be $10.6 billion Presentation Information: Title: A Phase 2 Double-Blind, Placebo-Controlled Study Showing Oral Tableted Norovirus Vaccine VXA-G1.1-NN is Immunogenic, Efficacious, and Reduces Viral Shedding Following Norovirus ChallengeSpeaker: Dr. Sean Tucker, Founder and Chief Scientific Officer of VaxartDate: Thursday, October 17Time: 3:45 p.m. PTRoom: 404 AB Title: A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 years Old and Their Breast-feeding InfantsSpeaker: Dr. Lam Nguyen, Medical Director & Head of Pharmacovigilance of VaxartDate: Saturday, October 19, 2024Time: 2:15 p.m. PTRoom: 403 B About VaxartVaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and to eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Contact Vaxart Media and Investor RelationsMatt SteinbergFINN PartnersIR@vaxart.com(646) 871-8481 This press release was published by a CLEAR® Verified individual.

VaccinePhase 2Phase 1

07 Sep 2023

·www.fiercebiotech.com

Vaxart norovirus vaccine fails to stop symptoms in midphase test but hits on other endpoints

Vaxart’s stock rose 1.7% to 81 cents in premarket trading. Vaxart is still looking a little queasy. The biotech delivered mixed data on its oral monovalent norovirus vaccine candidate, with the failure to cut acute gastroenteritis in the challenge study ensuring a muted response from investors despite successes on other endpoints. For the midphase challenge study, investigators randomized people to receive VXA-G1.1-NN, an adenoviral-vector based norovirus vaccine, or placebo. One month after vaccination, the subjects entered an isolation ward and were exposed to the norovirus strain targeted by the vaccine. One primary endpoint looked at the rate of acute gastroenteritis by monitoring subjects for symptoms such as diarrhea, vomiting and nausea in the week after they were exposed to the virus. VXA-G1.1-NN failed to perform significantly better than placebo on a composite endpoint of norovirus gastroenteritis, with 44.7% of participants suffering symptoms in the treatment group compared to 56.9% in the control. Talking on a conference call with investors to discuss the results, James Cummings, M.D., chief medical officer at Vaxart, predicted that the vaccine may perform better outside of the artificial challenge environment. “We use lots of copies of virus to ensure a high infection rate. In nature, 10 to 15 copies of virus is generally enough to give certain susceptible individuals disease. Field efficacy generally goes up, because the amount of inoculum that is causing disease that will be seen in the field is far lower than what is seen in the challenge study,” Cummings said. “My projection is that we would see an improvement in the decrease of [acute gastroenteritis] with our vaccine.” The potential for the vaccine to perform better in field studies was one cause for optimism identified by Vaxart. Infection data were another positive. In the 76 recipients of VXA-G1.1-NN, Vaxart saw a norovirus infection rate of 47.9%. The infection rate was lower than the 81.5% figure seen in the control group, resulting in a statistically significantly 29% relative risk reduction. Vaxart sees the finding as evidence that its vaccine can reduce viral transmission. “The 29% rate of infection certainly decreases the chance of transmitting virus to others, and I would fold into that the decrease in viral shedding as well,” Cummings said. “That may also decrease transmission in those close contact environments. That's, to me, the two-pronged benefit of those findings.” The company is continuing to analyze the data to inform a larger phase 2b trial and identify ways to cut the size and duration of a planned registration trial. Vaxart is also working on a bivalent vaccine that may provide broader protection. Investors were largely unmoved by the update, sending the biotech’s stock up 1.7% to 81 cents in premarket trading.

VaccinePhase 2Clinical Result

100 Deals associated with Monovalent norovirus Vaccine(Vaxart)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Norovirus Infections	Phase 2	United States	Vaxart, Inc.	26 Jan 2023
Gastroenteritis	Phase 2	United States	Vaxart, Inc.	27 Dec 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05212168 (G1-1 Challenge, CTgov)	Phase 1/2	Norovirus Infections \| Gastroenteritis	165	VXA-G1.1 (VXA-G1.1-NN)	buvdlsnrxh = lapiybfaie fzxhuldrbo (vinpeonytj, dbprbqeboq - xyavdvwyra) View more	-	06 May 2025
				placebo (Placebo)	buvdlsnrxh = crpsqzmlft fzxhuldrbo (vinpeonytj, jnffajfcyb - fudbpqzdvz) View more
NCT05626803 (CTgov)	Phase 2	Norovirus Infections	135	VXA-GII.4-NS+VXA-G1.1-NN (Bivalent GI.1/GII.4 Vaccine Medium Dose)	ueprwfavil = yzgmvjnulu hcuxqmxbaj (tpmgayyloy, aanalbpkue - qchgozofnj) View more	-	15 Apr 2025
				Bivalent GI.1/GII.4 Vaccine (Bivalent GI.1/GII.4 Vaccine High Dose)	ueprwfavil = dmifgjnuwn hcuxqmxbaj (tpmgayyloy, eytlwhrjfh - owfghodotf) View more
NCT04875676 (VXA-NVV-105, CTgov)	Phase 1/2	Norovirus Infections	30	VXA-G1.1-NN (Cohort 1 (4-week Boost Vaccination))	pdobshwexy(esdgpscrxy) = gpkazcsuve octngykebo (stcncuubua, jjyeuldlvd - lezwkkzqmg) View more	-	22 May 2024
				VXA-G1.1-NN (Cohort 2 (8-week Boost Vaccination))	pdobshwexy(esdgpscrxy) = yxwicqcqcc octngykebo (stcncuubua, rocamiippv - igpzsoafpp) View more

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