A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

Phase 1

Active, not recruiting

• Conditions: Norovirus Infections
• Interventions: Biological: VXA G1.1 NN-T; Biological: VXA-G1.1-NN; Biological: VXA G2.4 NS-T; Biological: VXA-G2.4-NS

• Registration Number: NCT06944717
• Lead Sponsor: Vaxart

Brief Summary

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-03
• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-25
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Bivalent Low Dose Next Generation Vaccine	VXA G1.1 NN-T	Healthy participants will receive Norovirus GI.1 Norwalk VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G1.1-NN-T) (1x10\^10 infectious units (IU)) and Norovirus GII.4 Sydney VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS-T) (1x10\^10 IU) orally.
Bivalent Low Dose Next Generation Vaccine	VXA G2.4 NS-T	Healthy participants will receive Norovirus GI.1 Norwalk VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G1.1-NN-T) (1x10\^10 infectious units (IU)) and Norovirus GII.4 Sydney VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS-T) (1x10\^10 IU) orally.
Bivalent High Dose Legacy Vaccine	VXA-G1.1-NN	Healthy participants will receive Norovirus GI.1 Norwalk Vaccine Protein 1 (VP1) Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded ribonucleic acid (dsRNA) Adjuvant (VXA-G1.1-NN) (1x10\^11 IU) and Norovirus GII.4 Sydney VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS) (1x10\^11 IU) orally.
Bivalent High Dose Legacy Vaccine	VXA-G2.4-NS	Healthy participants will receive Norovirus GI.1 Norwalk Vaccine Protein 1 (VP1) Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded ribonucleic acid (dsRNA) Adjuvant (VXA-G1.1-NN) (1x10\^11 IU) and Norovirus GII.4 Sydney VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS) (1x10\^11 IU) orally.
Bivalent High Dose Next Generation Vaccine	VXA G1.1 NN-T	Healthy participants will receive VXA-G1.1-NN-T (1x10\^11 IU) and VXA-G2.4-NS-T (1x10\^11 IU) orally. A sentinel group will be enrolled, if there is positive recommendation from the safety monitoring committee, enrollment will continue in this arm.
Bivalent High Dose Next Generation Vaccine	VXA G2.4 NS-T	Healthy participants will receive VXA-G1.1-NN-T (1x10\^11 IU) and VXA-G2.4-NS-T (1x10\^11 IU) orally. A sentinel group will be enrolled, if there is positive recommendation from the safety monitoring committee, enrollment will continue in this arm.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose	7 days
Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose	Approximately 1 year
Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose	7 days
Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose	28 days
Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose	28 days
Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose	Approximately 1 year
Duration of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose	Approximately 1 year
Severity of Unsolicited AEs for 28 Days Following the Study Intervention Dose	28 days
Severity of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose	28 days
Geometric Mean Titer (GMT) at Day 0 of Serum Functional Antibody Against GI.1 Measured by Norovirus Blocking Antibody Assay (NBAA)	Day 0
GMT at Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA	Day 28
GMT at Day 0 of Serum Functional Antibody Against GII.4 Measured by NBAA	Day 0
GMT at Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA	Day 28
Geometric Mean Fold Rise (GMFR) from Day 0 to Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA	From Day 0 to Day 28
GMFR from Day 0 to Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA	From Day 0 to Day 28

Trial Locations

Locations (1)

Johnson County Clin Trials - JCCT; 🇺🇸 Lenexa, Kansas, United States