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

NCT06524947 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: LKM-2023-NoV01
• Study Type: interventional
• Target: 6,600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Gastroenteropathy Due to Norovirus

Keywords

prevention

Outcome Measures

Primary Outcomes (11)

• Protective efficacy against AGE caused by four genotypes of norovirus

  Protective efficacy against AGE caused by the four genotypes included in the prophylactic vaccine (GI.1, GII.3, GII.4, GII.17) (co-infections of rotavirus and adenovirus were excluded) after 7 days of full immunization until the end of the observation period.Protective efficacy = 1 - (person-years of incidence in the vaccine group/person-years of incidence in the placebo group) × 100%; person-years of incidence = (number of cases of AGE (excluding co-infections with rotavirus and adenovirus) caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, and GII.17) after 7 days of 3 doses of the vaccine/number of person-years of observation) × 100%.

  From 7 days after full immunization to 2 years after 7 days after after full immunization

• Geometric mean titers (GMT) of IgG antibody

  Geometric mean titers of IgG antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.

  31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization

• Geometric mean titers (GMT) of HBGA blocking antibody

  Geometric mean titers of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.

  at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization

• Positive conversion rate of IgG antibodies

  Positive conversion rate of IgG antibody against norovirus (GI.1, GII.3, GII.4, GII.17) at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization.

  31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization

• Positive conversion rate of HBGA blocking antibody

  The positive conversion rate of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) was measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.

  31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization

• Geometric mean titers Growth multiplier of IgG antibody

  Geometric mean titers Growth multiplier of IgG antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.

  at 31 days after 2 doses of immunization and at 31 days after full immunization

• Geometric mean titers Growth multiplier of HBGA blocking antibody

  Geometric mean titers Growth multiplier of HBGA blocking antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.

  at 31 days after 2 doses of immunization and at 31 days after full immunization

• Occurrence of any adverse event

  Occurrence of any adverse event within 30 minutes of each dose of vaccination.

  within 30 minutes of each dose of vaccination

• Occurrence of recruited adverse event

  Occurrence of recruited adverse event between day 0 and day 7 after each dose of vaccination.

  between day 0 and day 7 after each dose of vaccination

• Occurrence of non-recruited adverse event

  Occurrence of non-recruited adverse event between day 0 and day 30 after each dose of vaccination.

  between day 0 and day 30 after each dose of vaccination

• Occurrence of serious adverse event

  Occurrence of serious adverse event from the first dose to 180 days after full immunization.

  from the first dose to 180 days after full immunization

Study Arms (6)

Infant experimental group (6 weeks -23 months)

EXPERIMENTAL

At least 6 weeks old but less than 2 years old.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)

Infant placebo control group (6 weeks -23 months)

PLACEBO COMPARATOR

At least 6 weeks old but less than 2 years old.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo

Toddler experimental group (2-5 years old)

EXPERIMENTAL

At least 2 years old but less than 6 years old.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)

Toddler placebo control group (2-5 years old)

PLACEBO COMPARATOR

At least 2 years old but less than 6 years old.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo

Children experimental group (6-13 years old)

EXPERIMENTAL

At least 6 years of age but under 14 years of age.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)

Children placebo control group (6-13 years old)

PLACEBO COMPARATOR

At least 6 years of age but under 14 years of age.

Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo

Interventions

quadrivalent recombinant norovirus vaccine (Pichia pastoris) BIOLOGICAL

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

Children experimental group (6-13 years old); Infant experimental group (6 weeks -23 months); Toddler experimental group (2-5 years old)

quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo BIOLOGICAL

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

Children placebo control group (6-13 years old); Infant placebo control group (6 weeks -23 months); Toddler placebo control group (2-5 years old)

Eligibility Criteria

• Age: 6 Weeks - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject's legal guardian agrees to participate in the trial (consent is also required for subjects 8 years of age and older), and can provide proof of legal identity, is fully informed and has signed an informed consent form, and understands and complies with the requirements of the trial protocol to participate in the follow-up visits.
• The age of the subjects on the day of enrollment is not less than 6 weeks old and not more than 13 years old, regardless of gender.
• Those younger than 12 months of age: 2.5kg ≤ birth weight ≤ 4.5kg, 37 weeks ≤ weeks of gestation ≤ 42 weeks, born in normal labor (excluding severe abnormal labor and history of severe asphyxia resuscitation).

You may not qualify if:

• Allergic to or having a history of specific reactions to any component of the investigational vaccine; Previous history of severe allergy to any vaccine or drug (such as anaphylactic shock, laryngeal edema, anaphylactic purpura, local anaphylactic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc.); People with allergic constitution.
• A history of confirmed norovirus infection within 2 years.
• Have a history of any of the following diseases or are suffering from serious diseases: ① Abnormal coagulation function: such as leukemia, congenital or acquired coagulation factor deficiency, aplastic anemia, thrombocytopenia and receiving anticoagulation therapy; ② Diseases affecting local observation: such as rational jaundice; ③Diseases affecting immune function: a history of congenital or acquired immunodeficiency or autoimmune disease; Uncontrolled lymphoproliferative diseases (such as chronic lymphocytic leukemia, Hodgkin's lymphoma, etc.); No spleen, or splenic surgery history, trauma history; ④Now suffering from infectious diseases: such as tuberculosis, viral hepatitis, etc； ⑤Neurological and psychiatric diseases: epilepsy, congenital brain hypoplasia, brain trauma, brain tumor, infection, brain nerve tissue damage caused by chemical and physical factors, etc., psychiatric history and family history； ⑥Other serious diseases that may interfere with the conduct or completion of the study: severe congenital malformations, severe developmental disorders, severe malnutrition, malignant tumors, congenital cardiovascular, liver, kidney diseases, etc.
• Received blood or blood-related products (other than hepatitis B immunoglobulin) within 1 month prior to enrollment; Long-term use of systemic immunosuppressants or other immunomodulatory drugs within 3 months (defined as use for more than 14 days).
• Have participated or are participating in other clinical trials (including drugs, biologics, or devices) within 3 months prior to enrollment.
• The investigator believes that the subject has any disease or condition that could put the subject at risk, poor adherence or inability to complete the trial as required by the protocol, and conditions that interfere with the evaluation of vaccine response.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (3)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530028, China

Location

Hunan Center for Disease Control and Prevention

Changsha, Hunan, 410153, China

Location

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, 610041, China

Location

Study Officials

• teng huang, master

  Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 29, 2024
• Study Start: July 27, 2024
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

CN (3)