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

Norovirus Infections Clinical Trial

Official title:

A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188691
• Other study ID #: CXSL1700011-I
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2019
• Est. completion date: December 13, 2020

Study information

• Verified date: April 2020
• Source: National Vaccine and Serum Institute, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups（6-17-year-old，3-5-year-old） of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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. In addition to the general exclusion criteria, specific populations should also adhere to

the following exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Gastroenteritis
• Norovirus Infections
• Norwalk Gastroenteritis

Intervention

Biological:
• Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)administered intramuscularly according to a 0, 28,(56) day vaccination schedule
• Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle)administered intramuscularly according to a 0, 28,(56) day vaccination schedule
• Norovirus Bivalent (GI.1 / GII.4) Vaccine(high)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(high)administered intramuscularly according to a 0, 28,(56)day vaccination schedule
• Normal saline
Normal saline administered intramuscularly according to a 0, 28 ,(56)day vaccination schedule
• Aluminum adjuvant
Aluminum adjuvant administered intramuscularly according to a 0, 28,(56) day vaccination schedule

Locations

Country	Name	City	State
China	qixian Center for Disease Control and Prevention	Hebi	Henan

Sponsors (4)

Lead Sponsor	Collaborator
National Vaccine and Serum Institute, China	Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd., Lanzhou Institute of Biological Products Co., Ltd, Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE of local and systemic reactions within 30 minutes after each dose		30 minutes
Primary	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
Primary	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
Primary	All SAEs within 6 months after the last dose is vaccinated		6 months
Secondary	Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies		28 days after the full vaccination
Secondary	Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies		28 days after the full vaccination
Secondary	Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers		28 days after the full vaccination
Secondary	Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates		28 days after the full vaccination