NCT06524947

Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)

Phase III Clinical Trial to Evaluate the Protective Efficacy, Immunogenicity, and Safety of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in People Aged 6 Weeks to 13 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,600 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 13 Years
• Healthy volunteers: Accepted

Summary

The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.

Detailed description

Overall design: A multicenter, randomized, double-blind, placebo-controlled trial was designed. The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals. Protective effectiveness evaluation:All subjects entered the observation period 7 days after completing the first dose of immunization. Stool and/or vomit samples (if applicable) from all AGE cases occurring during the observation period were collected and AGE caused by Norovirus was identified by PCR.Primary protective efficacy was calculated using data from primary endpoint cases that occurred between 7 days after completion of full immunization and the end of the observation period. Immunogenicity evaluation:For the immunogenic subgroup of subjects (120 subjects before the study number of each age group in a clinical trial site, a total of 360 subjects), blood samples were collected before the first dose of immunization, 31 days after the second dose of immunization, 31 days, 180 days, 1 year and 2 years after the total immunization, and blood samples were 2.5\~3.0ml each time.It is used to detect anti-norovirus IgG antibody, tissue Blood group antigen (HBGA) blocking antibody, and to detect the immunogenicity of anti-norovirus. Safety evaluation:Adverse events (AE) and serious adverse events (SAE) : All enrolled subjects collected AE 30 minutes after each dose of vaccine, enlisted AE 0-7 days, non-enlisted AE 0-30 days, and SAE from the first dose to 180 days after full immunization.

Conditions

• Acute Gastroenteropathy Due to Norovirus

Interventions

Type	Name	Description
BIOLOGICAL	quadrivalent recombinant norovirus vaccine (Pichia pastoris)	Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) at a 30-day interval. Main ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoVGII.4-VP1 protein, recombinant ReNoV GII.17-VP1 protein, aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate
BIOLOGICAL	quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo	Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo at a 30-day interval. Main ingredients: aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate

Timeline

• Start date: 2024-07-27
• Primary completion: 2027-03-28
• Completion: 2027-03-28
• First posted: 2024-07-29
• Last updated: 2025-01-23

Locations

3 sites across 1 country: China