VXA-GI.1.NN / Vaxart - LARVOL DELTA

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: Vaxart | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

VXA-NVV-105: Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: Vaxart | Phase classification: P1b ➔ P1/2

Phase classification • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial completion date: Apr 2024 ➔ Jul 2024

Trial completion date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Infectious Disease

G1-1 Challenge: Norovirus Challenge Study (clinicaltrials.gov) - P1/2 | N=165 | Completed | Sponsor: Vaxart | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P1/2 | Trial completion date: Jun 2024 ➔ Oct 2023

Phase classification • Trial completion • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial primary completion date • Infectious Disease

G1-1 Challenge: Norovirus Challenge Study (clinicaltrials.gov) - P2b | N=165 | Active, not recruiting | Sponsor: Vaxart | Recruiting ➔ Active, not recruiting | N=120 ➔ 165

Enrollment change • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Vaxart | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

G1-1 Challenge: Norovirus Challenge Study (clinicaltrials.gov) - P2b | N=120 | Recruiting | Sponsor: Vaxart | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Vaxart | N=623 ➔ 135 | Initiation date: Dec 2022 ➔ Feb 2022

Enrollment change • Trial initiation date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=623 | Recruiting | Sponsor: Vaxart | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=623 | Not yet recruiting | Sponsor: Vaxart

New P2 trial • Infectious Disease

(VXA-G1-1-NN): 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) Administered to Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Vaxart | Recruiting ➔ Completed

Trial completion • Infectious Disease

G1-1 Challenge: Norovirus Challenge Study (clinicaltrials.gov) - P2b | N=120 | Recruiting | Sponsor: Vaxart | Trial completion date: Sep 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

(VXA-G1-1-NN): 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) Administered to Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Vaxart

New P1 trial • Infectious Disease

VXA-NVV-104: Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine (clinicaltrials.gov) - P1b; N=66; Completed; Sponsor: Vaxart; Recruiting ➔ Completed; Trial completion date: Jun 2022 ➔ Jan 2022; Trial primary completion date: Aug 2021 ➔ Jan 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

G1-1 Challenge: Norovirus Challenge Study Placeholder (clinicaltrials.gov) - P2b | N=120 | Recruiting | Sponsor: Vaxart

New P2b trial • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • PCR

VXA-NVV-105: Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines (clinicaltrials.gov) - P1b; N=30; Completed; Sponsor: Vaxart; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

VXA-NVV-104: Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine (clinicaltrials.gov) - P1b; N=66; Recruiting; Sponsor: Vaxart; N=48 ➔ 66

Clinical • Enrollment change • Infectious Disease

VXA-NVV-105: Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines (clinicaltrials.gov) - P1b; N=30; Active, not recruiting; Sponsor: Vaxart; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

VXA-NVV-105: Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines (clinicaltrials.gov) - P1b; N=30; Recruiting; Sponsor: Vaxart

Clinical • New P1 trial • Infectious Disease

VXA-NVV-103: Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines (clinicaltrials.gov) - P1; N=86; Completed; Sponsor: Vaxart; Recruiting ➔ Completed; Trial completion date: Jun 2020 ➔ Apr 2021; Trial primary completion date: Oct 2019 ➔ Jan 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

VXA-NVV-104: Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine (clinicaltrials.gov) - P1b; N=48; Recruiting; Sponsor: Vaxart

Clinical • New P1 trial • Infectious Disease