A Phase 1, Single Center, Open Label, Single Dose, Dose Escalation Study to Determine the Safety and Immunogenicity of a Novel Bivalent Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Volunteers Aged ≥ 18 Years and ≤ 80 Years Old
Sponsor study identifier
interventional
60
1 country
1
Study Start
March 3, 2025
Actual (reported)Primary Completion
April 14, 2026
Actual (reported)Study Completion
April 14, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 14, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2025
Actual (reported)April 17, 2025
Actual (reported)April 25, 2025
Actual (reported)April 14, 2026
Actual (reported)April 14, 2026
Actual (reported)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
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.
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.
Legacy vaccine, administered orally.
Legacy vaccine, administered orally.
Johnson County Clin Trials - JCCT
Lenexa, Kansas, 66219, United States
60 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2025
First Posted
April 25, 2025
Study Start
March 3, 2025
Actual (reported)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
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.
Next generation vaccine, administered orally.
Next generation vaccine, administered orally.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 14, 2026
Actual (reported)Study Completion
April 14, 2026
Actual (reported)Last Updated
July 27, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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