A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

NCT04188691 | Completed Phase 1 DMC

• 1 other identifier: CXSL1700011-I
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.

Conditions

Norwalk Gastroenteritis; Norovirus Infections

Outcome Measures

Primary Outcomes (4)

• AE of local and systemic reactions within 30 minutes after each dose

  30 minutes

• All active AEs within 0-7 days after each dose

  Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination

  7 days

• All non-active collection AEs within 0-28（30） days after each dose

  Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window

  28（30） days

• All SAEs within 6 months after the last dose is vaccinated

  6 months

Secondary Outcomes (4)

• Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies

  28 days after the full vaccination

• Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies

  28 days after the full vaccination

• Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers

  28 days after the full vaccination

• Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates

  28 days after the full vaccination

Study Arms (5)

vaccine group 1

EXPERIMENTAL

vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose

Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）

vaccine group 2

EXPERIMENTAL

vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose

Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）

vaccine group 3

EXPERIMENTAL

vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose

Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）

Normal saline

PLACEBO COMPARATOR

（0.5ml / dose）produced by NVSI

Biological: Normal saline

Aluminum adjuvant

PLACEBO COMPARATOR

（0.5ml / dose）produced by NVSI

Biological: Aluminum adjuvant

Interventions

Norovirus Bivalent (GI.1 / GII.4) Vaccine（low） BIOLOGICAL

Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule

vaccine group 1

Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） BIOLOGICAL

Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule

vaccine group 2

Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） BIOLOGICAL

Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule

vaccine group 3

Normal saline BIOLOGICAL

Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule

Normal saline

Aluminum adjuvant BIOLOGICAL

Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule

Aluminum adjuvant

Eligibility Criteria

• Age: 6 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 6 months to 59 years old, can provide legal identification of Chinese population;
• Based on medical history and physical examination, determined by the researcher as healthy;
• Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
• Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.

You may not qualify if:

• Axillary body temperature before inoculation on the day of entry\> 37.0 ℃;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
• Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
• Those who received immunoenhancement or inhibitor therapy within months (continuous oral or instillation for more than 14 days);
• Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
• No spleen or spleen function defect caused by any situation;
• Severe liver and kidney disease, drug-uncontrollable hypertension (systolic blood pressure\> 140mmHg, diastolic blood pressure\> 90mmHg), diabetic complications, malignant tumors, various acute diseases or chronic attacks of acute diseases;
• Have a history of chronic gastrointestinal diseases, diarrhea or other digestive system diseases, and have had gastroenteritis requiring treatment in the past 7 days;.
• Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
• Have a history of severe allergic reactions to vaccination; are allergic to any component of the test vaccine;
• Live attenuated vaccine within14 days; other vaccines received within 7 days;
• Participating in other clinical trials in the near future;
• The investigator judges other circumstances that are not suitable for participation in this clinical trial.
• Premature birth (delivery before the 37th week of pregnancy), low weight (birth \<2300g) infants under 24 months of age;
• History of salvage, birth apnea, or other causes of salvage, neurological damage, severe chronic disease (such as Down syndrome, sickle cell anemia, or neurological disorders) in children under 24 months of age.

Sponsors & Collaborators

• National Vaccine and Serum Institute, China: lead
• Lanzhou Institute of Biological Products Co., Ltd: collaborator
• Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.: collaborator
• Zhengzhou University: collaborator

Study Sites (1)

qixian Center for Disease Control and Prevention

Hebi, Henan, China

Location

MeSH Terms

Conditions

Caliciviridae Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 6, 2019
• Study Start: November 28, 2019
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2020
• Last Updated: April 22, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)