NCT05626803 - A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers | Biotech Hunter

Enrollment

135

Participants

Timeline

Start Date

January 26, 2023

Primary Completion Date

October 16, 2023

Study Completion Date

October 16, 2023

Conditions

Norovirus Infections

Interventions

DRUG

Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose

The first 10 sentinel subjects will receive open label high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose

DRUG

Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose

50 subjects will receive high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose

DRUG

Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose

50 subjects will receive Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets; total dose is 1×10 to the power 11 IU/dose

DRUG

Placebo

25 subjects will receive matching placebo

Trial Locations (3)

55114

Nucleus Network Pty Ltd, Saint Paul

66219

Johnson County Clin-Trials, Lenexa

90806

Ark Clinical Research, Long Beach